What changed in this filing

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Item 1. Business

2026-03-30 compared with 2025-03-31 · 338 added, 487 removed, 650 unchanged (56% of the section changed)

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esoteric molecular diagnostic testing and pathology services to aid physicians in their evaluation of cancer risk in patients with indeterminate

biopsies and a perceived high risk of cancer from clinical features.

We develop and commercialize genomic tests and related first-line

assays that can personalize medicine to help improve patient diagnosis and management.

biopsies and a perceived risk of cancer from clinical features.

We develop and commercialize genomic tests that can personalize medicine

to help improve patient diagnosis and management.

Due to the decision of CMS to cease reimbursement coverage of our PancraGEN ®

test for assessing the risk of pancreatic cyst progression to cancer on April 24, 2025 which resulted in specimens for first-line fluid

chemistry and PancraGEN ® testing not being accepted by the Company after May 2, 2025, we are currently concentrating our

efforts on our molecular diagnostic tests for thyroid cancer, ThyGeNEXT ® and ThyraMIR ® v2.

Customer Category

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● Cancer Centers

Clinical services that help guide patient management decisions by providing information on the diagnosis and prognosis of indeterminate specimens.

Guidance on genetic marker-related pharmaceutical treatment options, when available, is also provided.

● Commercial laboratories

● Pathology groups

Clinical services that help guide patient management decisions by providing information on the diagnosis and prognosis of indeterminate specimens.

Guidance on genetic marker-related pharmaceutical treatment options, when available, is also provided.

Our clinical services’

customers consist primarily of physicians, hospitals, cancer centers, commercial laboratories, pathology groups and clinics.

customer for ThyGeNEXT ® and ThyraMIR ® v2 products in 2024 was Laboratory Corporation of America ®

customer in 2025 for ThyGeNEXT ® and ThyraMIR ® v2 was Laboratory Corporation of America ® or

Our revenue channels include reimbursement by Medicare, Medicare Advantage, Medicaid, and direct client billings (for example,

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The global esoteric molecular

diagnostics market, valued at $29.9 billion (USD) in 2023 and is expected to grow to $48.3 billion (USD) by 2029 with a Compound Annual

Growth rate or CAGR of 8.5% between 2023 and 2029, according to MarketsandMarkets™ (Report Code:

MD5930, published June 2024).

diagnostics market, valued at $29.6 billion (USD) in 2025, is projected to grow to $32.6 billion (USD) in 2026 and to $75.9 billion (USD)

by 2034, exhibiting a Compound Annual Growth rate, or CAGR, of 11.12% during the forecast period, according to Fortune Business Insights™

FBI108868, Updated January, 2026).

We believe that the specialty

molecular diagnostics market offers significant growth and strong patient value given the substantial opportunity it affords to lower

healthcare costs by helping to reduce unnecessary surgeries and ensuring the appropriate frequency of monitoring.

We are keenly focused

on growing our test volumes;

securing additional insurance coverage and reimbursement;

healthcare costs by helping to reduce unnecessary surgeries.

We are keenly focused on growing our test volumes;

securing additional insurance

coverage and reimbursement;

maintaining and growing our current reimbursement;

supporting revenue growth for our molecular diagnostic tests;

introducing related first-line product and service extensions;

and expanding

our business by developing and promoting synergistic products in our markets.

We also believe that BarreGEN ® is a potentially

significant pipeline product, and we are continuing to support the development process.

supporting revenue growth for our molecular diagnostic

and expanding our business by developing and promoting synergistic products in our markets.

United States Clinical

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The American Cancer Society annually estimates new

cancer cases and deaths within the United States.

In 2025, there will be an estimated 2,041,910 new cancer cases and 618,120 cancer deaths,

corresponding to ~1,700 deaths per day.

The cancer burden is also shifting from older to younger adults and from men to women.

Additionally,

while cancer is the second most common cause of death in the United States, exceeded only by heart disease, it is the leading cause of

death among men aged 60-79 years of age and women aged 40-79 years of age.

cancer cases and deaths within the United States (US).

In 2026, there will be an estimated 2.1 million new cancer cases and more than

626,000 cancer deaths, corresponding to about 1,700 deaths per day.

In the United States, cancer

remains one of the most significant causes of mortality, ranking second overall and representing the primary cause of death for individuals

under the age of 85.

Over the course of a lifetime, roughly one in three men and one in three women will be diagnosed with an invasive

While cancer continues to be diagnosed most frequently in adults aged 65 and older, a growing share of cases now occurs in younger

Nearly three in ten diagnoses arise in individuals between 50 and 64 years of age, and approximately one in eight occur in

people younger than 50.

The incidence, deaths and

economic loss caused by cancer are staggering.

Cancer-attributed medical care costs in the United States are substantial and projected

to increase dramatically by 2030 to an estimated $246 billion (USD).

The following table taken from Common Cancer Types, originally published

by the National Cancer Institute (Updated:

May 10, 2024) shows estimated new cases and deaths in 2024 in the United States for selected

major cancer types:

Cancer-attributed medical care costs in the US are substantial and projected to increase

dramatically by 2030 to an estimated $246 billion (USD).

The following table adapted from the American Cancer Society ( Cancer Facts

& Figures 2026) shows estimated new cases and deaths in 2026 in the United States for selected major cancer types:

Estimated New Cases

Estimated Deaths

Breast (Female – Male)

310,720-2,790

Colon and Rectal (Combined)

Kidney (Renal Cell and Renal Pelvis)

Kidney (and Renal Pelvis)

Leukemia (All Type)

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Non-Hodgkin’s Lymphoma

goal is to drive exceptional growth while becoming a leader in providing high-quality and dependable personalized medicine.

strategy is to grow our business organically and by selectively partnering—which could potentially include licensing,

acquisitions or mergers, to generate positive returns for our shareholders.

We expect to not only continue to further develop our

existing gastrointestinal and endocrine assays but to also expand our presence in other markets where we have expertise and access.

Our existing customer base and broad-based capabilities provide us a unique window not only into our current customers’ needs

but also permit us to anticipate their future needs.

Given the potential loss of PancraGEN ® reimbursement, we

will adapt our strategy to mitigate the impact and continue to drive growth.

American Cancer Society.

Facts & Figures 2026.

American Cancer Society;

Our primary goal is to drive

exceptional growth while becoming a leader in providing high-quality and dependable personalized medicine.

Our strategy is to grow our

business organically and by selectively partnering—which could potentially include licensing, acquisitions or mergers, to generate

positive returns for our shareholders.

We expect to continue to further develop our existing endocrine assays and to also expand our presence

in other markets where we have expertise and access.

Our existing customer base and broad-based capabilities provide us a unique window

not only into our current customers’ needs but also permit us to anticipate their future needs.

Given the loss of CMS reimbursement

for PancraGEN ® which we discontinued in May 2025, we are adapting our strategy to mitigate the impact and continue to drive

The key tactics to achieve

our goals include:

Expanding awareness and use

of our existing commercial products, especially ThyGeNEXT ® and ThyraMIR ® v2 through omnichannel marketing

Continuing the clinical development and commercialization of BarreGEN ® , our esophageal cancer risk classifier for Barrett’s Esophagus, and accelerating and further expanding clinical studies for our inline assays;

Expanding awareness and use of our existing commercial products, ThyGeNEXT ® and ThyraMIR ® v2 through omnichannel marketing programs;

Implementation of automation and focus on improved operating efficiencies in the clinical laboratories to provide consistent superior quality testing and reporting at reduced costs;

Broadening coverage and reimbursement for our clinical tests including:

support of an internal managed care team;

Key Opinion Leaders to educate on the validity and utility of our testing services;

payer relationships and in-network contracts serving our diagnostic customers.

Continuing support of an internal managed care team;

Utilizing Key Opinion Leaders to educate on the validity and utility of our testing services;

Establishing payer relationships and in-network contracts serving our diagnostic customers.

Expanding our commercial sales staff rationally, while supporting our products with high quality data and studies;

Exploring partnering opportunities to acquire new technologies;

Exploring partnering or other opportunities to acquire new technologies and products;

Expanding understanding and utilization of our bioinformatics data to improve our assays and elevate scientific understanding of the genetic drivers of cancer progression and aggressiveness.

Additionally, we will focus on diversifying

our product portfolio and exploring new revenue streams.

Additionally, we will focus on diversifying our

product portfolio and exploring new revenue streams.

This includes investing in research and development to bring innovative diagnostic

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We aim to provide physicians

and patients with diagnostic options for detecting genomic and other molecular alterations that are associated with gastrointestinal,

endocrine, and lung cancers.

and patients with diagnostic options for detecting genomic and other molecular alterations that are associated with endocrine and potentially

other cancers.

Our clinical services’ customers consist primarily of physicians, hospitals and clinics.

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commercializes clinically useful molecular diagnostic tests and molecular pathology services.

We commercialize genomic tests and related

first-line assays principally focused on risk-stratification of cancer to help personalize medicine and improve patient diagnosis and

Our tests and services provide mutational analysis of genomic material contained in suspicious cysts, nodules, and lesions

with the goal of better informing surgery or surveillance treatment decisions in patients suspected of pancreatic, thyroid and other cancers.

We commercialize esoteric diagnostic tests

that are principally focused on risk-stratification of cancer to help personalize medicine and improve patient diagnosis and management.

Our tests and services provide pathological, mutational and epigenetic analysis of fine-needle aspiration (FNA) biopsies derived from

thyroid nodules, with the goal of better informing surgery or surveillance treatment decisions in patients suspected of thyroid cancer.

The molecular diagnostic tests we offer enable healthcare providers to stratify cancer risk, helping to avoid unnecessary surgical treatment

in patients at low risk, while also helping to identify patients that would benefit from increased surveillance or surgical intervention.

in patients at low risk, while also helping to identify patients that would benefit from a consideration of surgical intervention.

Our mission is to assist

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Our laboratory is licensed pursuant

to federal law under Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) and are accredited by College of American

Pathologists (“CAP”) and our products are approved by New York State.

We are leveraging our laboratory to refine and commercialize

our assays and products.

We aim to provide physicians and patients with diagnostic options for detecting genomic and other molecular alterations

that are associated with gastrointestinal, endocrine, and other cancers.

Our customers consist primarily of physicians, hospitals, and

We currently have five commercialized

to federal law under Clinical Laboratory Improvement Amendments of 1988 (CLIA) and is accredited by the College of American Pathologists

(CAP) and our products are approved by New York State.

We are leveraging our laboratory to refine and commercialize our assays and products.

We aim to provide physicians and patients with diagnostic options for detecting genomic and other molecular alterations that are associated

with endocrine cancer.

Our customers consist primarily of physicians, hospitals, and clinics.

We currently have two commercialized

molecular diagnostic tests in the marketplace:

PancraGEN ® , a pancreatic cyst and pancreaticobiliary solid lesion genomic

test that helps physicians better risk-stratify pancreaticobiliary cancers using our proprietary PathFinderTG ® platform

and full integration of clinical factors; PanDNA ® , an alternate reporting option of the PathFinderTG platform, that

provides physicians the “molecular only” information provided within PancraGEN;

ThyGeNEXT ® , an oncogenic mutation

panel that helps “rule-in” and “rule-out” malignancy in thyroid nodules; ThyraMIR ® v2, used

in combination with ThyGeNEXT ® , which further stratifies thyroid nodules for malignancy risk utilizing a proprietary microRNA

gene expression classifier;

and RespriDx ® a genomic test that also utilizes our PathFinderTG ® platform,

to help physicians differentiate metastatic or recurrent lung cancer from the presence of newly formed primary lung cancer.

Gastrointestinal Cancer Products

Our current diagnostic assay,

PancraGEN ® , is a reporting option of our proprietary PathFinderTG ® platform.

This platform is designed to

use advanced clinical algorithms to accurately risk-stratify patients suspected of having pancreatic cancer by assessing panels of DNA

abnormalities in patients who have pancreaticobiliary lesions (cysts or solid masses).

PanDNA ® is a “molecular only”

reporting option of PathFinderTG ® and is used by physicians who prefer to perform their own integration of first-line testing

results to stratify pancreatic cancer risk.

Based on the American Cancer

Society Cancer 2025 Cancer Facts and Figures, pancreatic cancer is the third leading cause of cancer deaths in the U.S.

(estimated) with

an average five-year survival rate of 13%.

PancraGEN ® and PanDNA ® assess the risk of malignancy in pancreatic

cysts and pancreaticobiliary solid lesions, which have potential for developing into cancer.

We believe that PancraGEN ®

is the leader in the market for integrated molecular diagnostic tests for determining risk of pancreaticobiliary malignancy.

estimate that the immediate addressable market for PancraGEN ® is approximately 124,000 mucinous indeterminate pancreaticobiliary

lesions annually or approximately $200 million annually based on the current size of the patient population and reimbursement rates.

date, PancraGEN ® testing has been used in over 80,000 clinical cases.

The National Pancreatic Cyst Registry study published

in Endoscopy in 2015 demonstrated that PancraGEN ® more accurately determined the malignancy potential of pancreatic

cysts than international consensus 2012 imaging criteria, helping to ensure that surgery is reserved for the most appropriate patients.

This is important because pancreatic surgery is high-risk surgery with over 40% postoperative morbidity rates and 0%–15% postoperative

mortality rates.

(Ahola, et al, March 2020, doi.org/10.1177/1457496919900411 ) When molecular analysis is not performed, the vast

majority of all pancreatic cyst surgeries are performed on cystic lesions that do not harbor malignancy.

The American Gastroenterological

Association 2015 Guidelines have cautioned that many pancreatic surgeries have been performed unnecessarily for lesions that will not

progress to invasive adenocarcinoma.

In addition, the 2016 guidelines published by the American Society of Gastroenterology Endoscopy

(ASGE) in Gastrointestinal Endoscopy included a specific recommendation for use of molecular testing in specific circumstances where other

types of testing and analysis have not provided sufficient data on which to determine the best course of action for patient treatment.

Most recently, the International

Association of Pancreatology (IAP) reviewed and revised their guidelines with a main objective being to update their patient management

These revised guidelines indicate that molecular markers can be used when the diagnosis of a pancreatic cyst is unclear and

will alter surveillance.

Additionally, the guidelines further indicate that molecular markers, such as the ones found within PancraGEN ® ,

can be useful in identifying the presence of high-grade dysplasia and invasive carcinoma.

( Pancreatology .

S1424-3903(23)01883-5.

10.1016/j.pan.2023.12.009).

Accordingly, we believe that PancraGEN ® provides a highly reliable diagnostic and prognostic

option that can accurately stratify cancer risk in circumstances where risk of cancer is otherwise uncertain.

As described below, on January

9, 2025, the Company announced the new LCD established non-coverage for its PancraGEN ® test, and it would stop offering

the test and would not accept specimens for first-line fluid chemistry and PancraGEN ® testing after February 7, 2025.

January 27, 2025, the Company announced that CMS had directed its Medicare Administrative Contractors, Novitas and First Coast Service

Options, Inc., to delay implementation of the Genetic Testing for Oncology LCD (L39365), from February 23, 2025 until April 24, 2025.

For more information, please see Part I – Item 1 – “Business – Government Regulations and Industry Guidelines

- Third Party Coverage and Reimbursement for our Clinical Services – Novitas LCD for PancraGEN .”

ThyGeNEXT ® , an oncogenic mutation panel that helps “rule-in”

and “rule-out” malignancy in thyroid nodules and ThyraMIR ® v2, used in combination with ThyGeNEXT ® ,

to help in further refining the malignancy risk of indeterminate thyroid nodules utilizing a proprietary microRNA gene expression classifier.

Endocrine Cancer Products

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guidance aligned to FDA-approved therapies for RET, NTRK , and other markers found within the panel.

ThyGeNEXT ® works

with our unique microRNA-based endocrine cancer diagnostic test, ThyraMIR ® v2.

This assay measures the expression of eleven

distinct microRNAs.

The combined analysis of the ThyGeNEXT ® and ThyraMIR ® v2 test results provides very narrow

malignancy risk ranges to help guide patient management decision-making.

The ThyGeNEXT ® assay

evaluates the most common mutations associated with thyroid cancer.

The results of this mutational analysis are then combined with the

results of our unique microRNA-based endocrine cancer diagnostic test, ThyraMIR ® v2.

This assay measures the expression

of eleven distinct microRNAs by both an algorithmic and pairwise expression analysis to further refine malignancy risk.

The microRNA analysis

can also inform malignancy risk in the absence of an identified mutation within the mutational analysis.

The combined analysis provided

by the ThyGeNEXT ® and ThyraMIR ® v2 testing platform, provides very high-performance metrics and narrow malignancy

risk ranges to help guide patient management decision-making.

We estimate the total market

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and throat (“ENT”), and other specialists evaluate thyroid nodules for possible cancer by collecting cells through fine-needle

Aspiration (“FNA”) that are then analyzed by cytopathologists to determine whether or not a thyroid nodule is cancerous.

is estimated that approximately 25% or well over 100,000 biopsies analyzed annually yield indeterminate results, meaning they cannot be

diagnosed as definitely being malignant or benign by cytopathology alone.

In the past, guidelines recommended that some patients with

indeterminate cytopathology results undergo surgery to remove all or part of their thyroid to obtain an accurate diagnosis by looking

directly at the thyroid tissue.

aspiration (FNA) biopsies that are then analyzed by cytopathologists to determine whether or not a thyroid nodule is cancerous.

estimated that approximately 25% or well over 100,000 biopsies analyzed annually yield indeterminate results, meaning they cannot be diagnosed

as definitely being malignant or benign by cytopathology alone.

In the past, guidelines recommended that some patients with indeterminate

cytopathology results undergo surgery to remove all or part of their thyroid to obtain an accurate diagnosis by looking directly at the

thyroid tissue.

According to a study published by Wang, et al.

in 2011, in approximately 77% of these cases, the thyroid

nodule proved to be benign.

Current practice and guidelines, such as those from the National Comprehensive Cancer Network (“NCCN”)

and American Thyroid Association (“ATA”), support use of molecular analysis for nodules with indeterminate cytology results

as this testing can prove beneficial to further characterize these lesions and help support optimal patient management.

We believe that our Endocrine

Cancer Products franchise for indeterminant thyroid nodules, ThyGeNEXT ® + ThyraMIR ® v2, is quite strong and

provides a solid foundation for continued growth and profitability should there be any change to existing test-specific local coverage

determinations for other Interpace testing services.

Lung Cancer Product — RespriDx ®

Test and Metastatic versus Primary Platform

RespriDx ® compares

the mutational fingerprint of two or more sites of cancer to determine whether the neoplastic deposits are representative of a recurrence

(metastasis) of lung cancer or a new primary or independent tumor.

The test, which currently provides only nominal revenues, defines the

presence or absence of cancer in atypical cytology by comparing the mutational profile with that of known previous cancer.

assists in determining the most appropriate course of treatment, whether chemotherapy, surgery, or other modalities.

in 2011, in approximately 77% of these cases, the thyroid nodule proved

to be benign.

Current practice and guidelines, such as those from the American Thyroid Association (ATA), support use of molecular analysis

for nodules with indeterminate cytology results as this testing can prove beneficial to further characterize these lesions and help support

optimal patient management.

The Endocrine Cancer Products

franchise for indeterminant thyroid nodules, ThyGeNEXT ® + ThyraMIR ® v2, continues to demonstrate its strength

in providing a solid foundation for continued growth, profitability, and Company expansion into other product offerings.

CLIA Certified and CAP Accredited Laboratory

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Our commercialization efforts

for our clinical services are mainly focused on endocrine (thyroid), and gastroenterologic (pancreatic) cancers.

Communication of our

marketing messaging and value propositions is accomplished through multiple channels, including two field-based commercial sales teams

of approximately 40 representatives and managers.

In addition, we employ medical science liaisons (MSLs)—therapeutic specialists

with advanced scientific training to aid in communicating complex scientific and medical information to leading physicians.

Other channels

of communication include print, digital advertising, social media, a web presence, peer-reviewed publications, and trade show exhibits.

We believe that our molecular diagnostic tests provide value to payers, physicians, and patients by improving patient care and lowering

healthcare costs through avoidance of unnecessary surgeries, reducing the morbidity associated with unnecessary surgeries for patients,

and providing better diagnostic and prognostic insights to physicians.

We support the value propositions of our tests through rigorous

science that supports the analytical and clinical validity as well as clinical utility of our tests.

for our clinical services are focused on endocrine (thyroid) cancer.

Communication of our marketing messages and value propositions is

accomplished through multiple channels, including a field-based commercial sales team of approximately 30 representatives and managers.

In addition, we employ therapeutic specialists with advanced scientific training to aid in communicating complex scientific and medical

information to leading physicians.

Other channels of communication include print, digital advertising, social media, a web presence, peer-reviewed

publications, and trade show exhibits.

We believe that our molecular diagnostic tests provide value to payers, physicians, and patients

by improving patient care and lowering healthcare costs through avoidance of unnecessary surgeries and by providing better diagnostic

and prognostic insights to physicians.

We support the value propositions of our tests through rigorous science that supports the analytical

and clinical validity as well as clinical utility of our tests.

We also communicate to payers,

integrated delivery systems and hospital systems about our molecular diagnostic tests’ value through highly trained professionals

who are experienced in reimbursement and business-to-business selling and through face-to-face meetings, phone calls, digital communications

and advisory boards.

who are experienced in reimbursement and business-to-business selling and through face-to-face meetings, phone calls, and digital communications.

We compete on the basis of

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other resources than we have.

Many of our competitors also offer broader product lines outside of the molecular diagnostic testing market,

and many have greater brand recognition than we do.

Moreover, our competitors may make rapid technological developments that may result

in our technologies and products becoming obsolete before we recover the expenses incurred to develop them or before they generate significant

Increased competition may lead to pricing pressures and competitive practices that could have a material adverse effect on our

market share and our ability to attract new business opportunities as well as our business, financial condition and results of operations.

Many of our competitors also offer broader product lines and some have greater brand recognition.

our competitors may make rapid technological developments that may result in our technologies and products becoming obsolete before we

recover the expenses incurred to develop them or before they generate significant revenue.

Increased competition may lead to pricing pressures

and competitive practices that could have a material adverse effect on our market share and our ability to attract new business opportunities

as well as our business, financial condition and results of operations.

We also compete with physicians

and the medical community who use traditional methods or local institution-created tests to diagnose gastrointestinal and endocrine cancers.

We believe that we will need to continue to educate physicians and the medical community on the value and benefits of our molecular diagnostic

tests in order to change clinical practices and continue to support the use of molecular diagnostic tests in clinical guidelines.

and the medical community who use traditional methods or local institution-created tests to diagnose endocrine cancers.

We believe that

we will need to continue to educate physicians and the medical community on the value and benefits of our molecular diagnostic tests in

order to change clinical practices and continue to support the use of molecular diagnostic tests in clinical guidelines.

Specifically, in regard to

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Afirma test in partnership with Veracyte.

Sonic, Inc., or Sonic, offers ThyroSeq ® , a diagnostic test that analyzes genetic

alterations using next-generation sequencing.

We are currently not aware

of any direct competitors to PancraGEN ® that fully integrate clinical, imaging, cytology, and molecular information to

stratify patients’ risk for malignancy and inform physicians on the best course of action, i.e., surgery or surveillance and surveillance

interval length.

The University of Pittsburgh Medical Center now offers PancreaSeq ® , a Next Generation Sequencing panel

that focuses on the analysis of mutations in oncogenes and tumor suppressor genes, most of which may help establish the type of pancreatic

cyst present and some of which may help establish the presence of malignancy.

Some of these related genomic regions are included in PancraGEN ® .

This competitive laboratory test also does not follow current physician patient management decision-making which includes the integration

of clinical features to fully characterize a patient’s risk for pancreatic cancer.

Importantly, there has been no long-term clinical

validation or utility studies completed on any gene panel for pancreatic cyst fluid other than that associated with PancraGEN ® .

PancraGEN ® has been validated in multiple studies and peer reviewed publications and has been used in over 80,000 patients

with up to approximately ~8 years of patient follow-up information.

Given the size of the Barrett’s

Esophagus market, there are companies who are either in the process of developing assays and LDTs to identify the condition or who have

started to commercialize diagnostic tests, such as the methylated biomarker test currently being marketed by Lucid Diagnostics.

We anticipate

that this space will become increasingly competitive as new diagnostic tests come to market in the future.

Sonic Healthcare USA, Inc., or Sonic, offers ThyroSeq ® , a diagnostic test that

analyzes genetic alterations using next-generation sequencing.

It is also possible that

we face future competition from other laboratory-developed tests (LDT’s), developed by commercial laboratories or by other diagnostic

companies utilizing different technologies in the gastrointestinal and endocrine cancer molecular diagnostic tests space.

we may face future competition from other laboratory-developed tests (LDTs), developed by commercial laboratories or by other diagnostic

companies utilizing similar or different technologies in the endocrine cancer molecular diagnostic tests space.

Research and Development

We continue to generate and

publish clinical evidence mainly related to our key products, including ThyGeNEXT ® and ThyraMIR ® v2 and PancraGEN ® .

publish clinical evidence mainly related to our products, ThyGeNEXT ® and ThyraMIR ® v2.

We conduct our research and

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covering our existing and future products and technologies.

As of December 31, 2024, we owned nine issued United States Patents.

As of December 31, 2025, we owned ten issued United States Patents.

patents are directed to, amongst other things, methods of measuring carcinoembryonic antigen in a biological sample;

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adjustments or extensions.

Our patents are directed to certain of the technologies relating to detecting, diagnosing, and classifying

Our patents are directed to certain technologies relating to detecting, diagnosing, and classifying

thyroid tumors, pancreatic cysts and other forms of gastrointestinal disorders, such as Barrett’s esophagus.

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January 13, 2017.

October 2014, we acquired RedPath Integrated Pathology Inc.

In October 2014, we acquired

RedPath Integrated Pathology Inc.

(RedPath) which included its pancreatic and gastrointestinal assets.

In May 2025, we discontinued sales

of PancraGEN ® , our molecular diagnostic test for pancreatic cancer, following the loss of CMS reimbursement.

Additionally,

we have a broad and growing trademark portfolio.

We have secured trademark registrations for the marks AccuCEA ® (or TM),

PancraGEN ® , PanDNA ® , BarreGEN ® and miR Inform ® in the United States,

and miR Inform ® with the World Intellectual Property Organization.

We have secured trademark registrations for the marks PancraGEN ® , PanDNA ® ,

and BarreGEN ® in the United States.

rely on a combination of trade secrets and proprietary processes to protect our intellectual property.

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Our most significant suppliers for reagents and

supplies include Thermo Fisher Scientific Inc., Illumina, Inc., Qiagen N.V., and F.

supplies include Thermo Fisher Scientific Inc., Illumina, Inc., Qiagen N.V., Mettler-Toledo Rainin, LLC., and F.

Hoffmann-La Roche AG.

While we have developed alternate

sourcing strategies for most of these materials and vendors, we cannot be certain whether these strategies will be effective or the alternative

sources will be available when we need them.

If these suppliers can no longer provide us with the materials we need to perform the tests

and for our collection kits, if the materials do not meet our quality specifications or are otherwise unusable, if we cannot obtain acceptable

substitute materials, or if we elect to change suppliers, an interruption in test processing could occur, we may not be able to deliver

patient reports and we may incur higher one-time switching costs.

Any such interruption may significantly affect our future revenue, cause

us to incur higher costs, and harm our customer relationships and reputation.

In addition, in order to mitigate these risks, we maintain

inventories of these supplies at higher levels than would be the case if multiple sources of supply were available.

If our test volume

decreases or we switch suppliers, we may hold excess lab supplies with expiration dates that occur before use which would adversely affect

our losses and cash flow position.

As we introduce any new test, we may experience supply issues as we ramp test volume.

While we have developed alternate sourcing strategies for most of these materials and vendors, we cannot be certain whether these strategies

will be effective or the alternative sources will be available when we need them.

If these suppliers can no longer provide us with the

materials we need to perform the tests and for our collection kits, if the materials do not meet our quality specifications or are otherwise

unusable, if we cannot obtain acceptable substitute materials, or if we elect to change suppliers, an interruption in test processing

could occur, we may not be able to deliver patient reports and we may incur higher one-time switching costs.

Any such interruption may

significantly affect our future revenue, cause us to incur higher costs, and harm our customer relationships and reputation.

in order to mitigate these risks, we maintain inventories of these supplies at higher levels than would be the case if multiple sources

of supply were available.

If our test volume decreases or we switch suppliers, we may hold excess lab supplies with expiration dates that

occur before use which would adversely affect our losses and cash flow position.

As we introduce any new test, we may experience supply

issues as we ramp test volume.

Government Regulations and Industry Guidelines

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exercised enforcement discretion over most LDTs.

On April 29, 2024, however, the FDA published a final rule on LDTs, in which the FDA

outlines its plans to end enforcement discretion for many LDTs in five stages over a four-year period.

In Phase 1 (effective May 6, 2025),

clinical laboratories running LDTs will be required to comply with medical device (adverse event) reporting and correction/removal reporting

requirements, as well as requirements for maintenance of complaint files under the FDA’s quality systems regulation (QSR).

2 (effective May 6, 2026), clinical laboratories will be required to comply with all other device requirements (e.g., registration/listing,

labeling, investigational use), except for the remaining QSR requirements and premarket review.

In Phase 3 (effective May 6, 2027), clinical

laboratories will be required to comply with all remaining applicable QSR requirements.

In Phase 4 (effective November 6, 2027), clinical

laboratories will be required to comply with premarket review requirements for high-risk tests (i.e., tests subject to the premarket approval

(PMA) requirement).

Finally, in Phase 5 (effective May 6, 2028), clinical laboratories will be required to comply with premarket review

requirements for moderate- and low-risk tests (i.e., tests subject to the de novo or 510(k) requirement).

Under the final rule, several

types of tests will be eligible for some degree of continued enforcement discretion.

For example, LDTs approved by the New York State

Department of Health will be exempt from premarket review requirements but will remain subject to the requirements of Phases 1 through

Similarly, LDTs first marketed prior to May 6, 2024 that are not subsequently modified, or are modified only in certain limited ways,

will be exempt from the premarket review and most quality systems requirements, but will remain subject to the requirements of Phases

The FDA notes, however, that it retains discretion to pursue enforcement action for violations of the Federal Food, Drug and

Cosmetic Act at any time and intends to do so when appropriate.

The FDA further explains that it may update any of the enforcement discretion

policies set forth in the final rule as circumstances warrant or if the circumstances that inform those policies change, consistent with

the FDA’s good guidance practices.

To the extent the FDA ultimately

regulates certain LDTs, our LDTs may be subject to certain additional regulatory requirements.

Complying with the FDA’s requirements

can be expensive, time-consuming, and subject us to significant or unanticipated delays.

Insofar as we may be required to obtain premarket

clearance or approval to perform or continue performing an LDT, we cannot assure you that we will be able to obtain such authorization.

Even if we obtain regulatory clearance or approval where required, such authorization may not be for the intended uses that we believe

are commercially attractive or are critical to the commercial success of our tests.

As a result, the application of the FDA’s requirements

to our tests could materially and adversely affect our business, financial condition, and results of operations.

On April 29, 2024, the FDA published a final rule that would have amended FDA’s

device regulations to phase out enforcement discretion for many LDTs.

On March 31, 2025, the District Court for the Eastern District of

Texas vacated the final rule.

As of the date of this filing, the vacatur remains in effect and FDA has not implemented the rule.

FDA continues to exercise enforcement discretion over most LDTs, consistent with historical practice.

The FDA retains authority

to regulate in vitro diagnostics as medical devices, and it is possible that the FDA could pursue new rulemaking, that Congress could

enact legislation addressing IVCTs or LDTs, or that a future court or agency action could alter the current framework.

Were FDA regulation

of LDTs to be reestablished in whole or in part in the future, our LDTs could become subject to additional regulatory requirements, including

potential premarket review, quality system, registration, or reporting obligations.

We cannot predict whether or when the FDA or Congress

may pursue further action.

Compliance with any such requirements could be expensive, time-consuming, and could subject us to significant

or unanticipated delays.

To the extent the FDA ultimately regulates certain LDTs, our LDTs may be subject to certain additional regulatory

requirements.

Complying with the FDA’s requirements can be expensive, time-consuming, and subject us to significant or unanticipated

Insofar as we may be required to obtain premarket clearance or approval to perform or continue performing an LDT, we cannot assure

you that we will be able to obtain such authorization.

Even if we obtain regulatory clearance or approval where required, such authorization

may not be for the intended uses that we believe are commercially attractive or are critical to the commercial success of our tests.

a result, the application of the FDA’s requirements to our tests could materially and adversely affect our business, financial condition,

and results of operations.

Additionally, if the FDA were in the future to require premarket review or device-level compliance for laboratory

developed tests, we could become subject to quality system regulations applicable to medical device manufacturers.

Failure to comply with applicable

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the effect of such proposals on our business.

Whether via statute, regulation, or sub-regulatory

action, any FDA effort to end enforcement discretion for LDTs is likely to continue to be met with resistance by certain sections of industry.

Multiple lawsuits have been filed challenging the April 2024 LDT final rule, in which the plaintiffs argue that the FDA lacks authority

to regulate LDTs as medical devices.

We cannot predict the likelihood of success of these or any other such actions, nor can we quantify

the effect of such efforts on our business.

Healthcare, Fraud, Abuse and Anti-Kickback

The federal Anti-Kickback

Statute makes it a felony for a person or entity, including a laboratory, to “knowingly and willfully” offer, pay, solicit

or receive remuneration, directly or indirectly, to another person or entity if the payment is intended to induce the recipient to refer

an individual to a person or to purchase, order, arrange for or recommend the purchase of any item or service that is reimbursable under

any federal health care program.

A violation of the Anti-Kickback Statute, which is an intent-based statute, may result in imprisonment

of up to 10 years and fines of up to $100,000 for each violation, or both.

Convictions under the Anti-Kickback Statute result in mandatory

exclusion from federal health care programs, generally for a minimum of five years.

In addition, the United States Department of Health

and Human Services (HHS) has the authority to impose civil monetary penalties and fines and to exclude healthcare providers and others

engaged in prohibited activities from Medicare, Medicaid and other federal health care programs.

Civil monetary penalties may be imposed

of up to $124,732 per violation and damages of up to three times the total amount of remuneration offered, paid, solicited or received

(these per-claim penalties are adjusted for inflation from time to time).

Violations of the Anti-Kickback Statute may, also incur liability

under the federal False Claims Act, discussed in more detail below, which prohibits, among other things, knowingly presenting, or causing

to be presented, a false or fraudulent claim for payment to the U.S.

Statute makes it a felony for a person or entity, including a laboratory, to (among other things) “knowingly and willfully”

offer, pay, solicit or receive remuneration, directly or indirectly, in exchange for or to induce the referral of an individual to a person

or to purchase, order, arrange for or recommend the purchase of any item or service that is reimbursable under any federal health care

A violation of the Anti-Kickback Statute, which is an intent-based statute, may result in imprisonment of up to 10 years and

fines of up to $100,000 for each violation, or both.

Convictions under the Anti-Kickback Statute result in mandatory exclusion from federal

health care programs, generally for a minimum of five years.

In addition, the United States Department of Health and Human Services (HHS)

has the authority to impose civil monetary penalties and fines and to exclude healthcare providers and others engaged in prohibited activities

from Medicare, Medicaid and other federal health care programs.

Civil monetary penalties may be imposed of up to $127,973 per violation

and damages of up to three times the total amount of remuneration offered, paid, solicited or received (these per-claim penalties are

adjusted for inflation from time to time).

Further, claims resulting from a violation of the Anti-Kickback Statute constitute false or

fraudulent claims under the federal False Claims Act, discussed in more detail below.

Although the Anti-Kickback

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by federal health care programs.

In addition to the Anti-Kickback

Statute, the Eliminating Kickbacks in Recovery Act of 2018, (EKRA) was enacted as part of the Substance Use-Disorder Prevention that Promotes

Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act).

In addition to the Anti-Kickback Statute, the

Eliminating Kickbacks in Recovery Act of 2018, (EKRA) was enacted as part of the Substance Use-Disorder Prevention that Promotes Opioid

Recovery and Treatment for Patients and Communities Act (SUPPORT Act).

EKRA is an all-payer anti-kickback law that makes it a criminal

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not issued proposed or final regulations or other guidance interpreting EKRA.

Recent enforcement actions and judicial interpretations

suggest that EKRA may apply more broadly than initially anticipated, including potentially to certain commission-based compensation arrangements

for laboratory sales personnel.

Regulatory guidance remains limited and enforcement interpretations may evolve.

Several other healthcare

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“usual charge” and “substantially in excess” are ambiguous and subject to varying interpretations.

federal False Claims Act, discussed in more detail below, prohibits, among other things, a person from knowingly submitting a claim, making

a false record or statement in order to secure payment or retaining an overpayment by the federal government.

In addition to actions initiated

by the government itself, the False Claims Act authorizes actions to be brought on behalf of the federal government by a private party,

known as a relator, having knowledge of the alleged fraud.

Because the complaint is initially filed under seal, the action may be pending

for some time before the defendant is even aware of the action.

If the government is ultimately successful in obtaining redress in the

matter or if the relator succeeds in obtaining redress without the government’s involvement, then the relator will receive a percentage

of the recovery.

Penalties under the federal False Claims Act can include up to three times the damages sustained by the federal program

and between $13,946 and $27,894 per claim (these per-claim penalties are adjusted for inflation from time to time).

Further, numerous

states have enacted state false claims acts that apply to state government programs.

Finally, the Social Security Act includes its own

provisions that prohibit the filing of false claims or submitting false statements in order to obtain payment.

Violation of these provisions

may result in fines, imprisonment or both, and possible exclusion from Medicare or Medicaid programs.

federal False Claims Act, discussed in more detail below, prohibits, among other things, a person from knowingly submitting a false or

fraudulent claim and making a false record or statement in order to secure payment or retaining an overpayment by the federal government.

In addition to actions initiated by the government itself, the False Claims Act authorizes actions to be brought on behalf of the federal

government by a private party, known as a relator, having knowledge of the alleged fraud.

Because the complaint is initially filed under

seal, the action may be pending for some time before the defendant is even aware of the action.

If the government is ultimately successful

in obtaining redress in the matter or if the relator succeeds in obtaining redress without the government’s involvement, then the

relator will receive a percentage of the recovery.

Penalties under the federal False Claims Act can include up to three times the damages

sustained by the federal program and between $14,308 and $28,619 per claim (these per-claim penalties are adjusted for inflation from

time to time).

Further, numerous states have enacted state false claims acts that apply to state government programs.

Finally, the Social

Security Act includes its own provisions that prohibit the filing of false claims or submitting false statements in order to obtain payment.

Violation of these provisions may result in fines, imprisonment or both, and possible exclusion from Medicare or Medicaid programs.

We are also subject to the

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that these arrangements are designed properly or that they do not trigger liability.

Under existing laws, all arrangements must have a

legitimate purpose and compensation must be fair market value.

Under existing laws, arrangements generally must

be commercially reasonable and often compensation must be fair market value.

These terms require some subjective analysis.

Safe harbors in the anti-kickback

laws do not necessarily equate to exceptions in the Stark Law;

and there is no guarantee that the government will not take issue with

the relationships between the laboratories and the healthcare providers.

in the anti-kickback laws do not necessarily equate to exceptions in the Stark Law;

and there is no guarantee that the government will

not take issue with the relationships between the laboratories and the healthcare providers.

HIPAA, Fraud and Privacy Regulations

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The FTC uses its

broad grant of authority to regulate data privacy and security, using its powers to investigate and bring lawsuits.

Where appropriate,

the FTC can seek a variety of remedies, such as but not limited to requiring the implementation of comprehensive privacy and security

programs, biennial assessments by independent experts, monetary redress to consumers, and provision of robust notice and choice mechanisms

to consumers.

broad grant of authority to regulate data privacy and security, using its powers to investigate, fueled by its authority to issue civil

investigative demands, and bring lawsuits.

Where appropriate, the FTC can seek a variety of remedies, such as but not limited to requiring

the implementation of comprehensive privacy and security programs, data and/or algorithmic disgorgement, biennial assessments by independent

experts, monetary redress to consumers, and provision of robust notice and choice mechanisms to consumers.

The FTC is not the sole regulator

in the federal arena, with the Department of Justice, or DOJ, taking recent steps to protect Americans’ bulk sensitive data against

intrusion or access by countries of concern.

The recent DOJ Final Rule on Preventing Access to Bulk US Sensitive Data by Countries of

Concern, codified at 28 CFR Part 202, imposes detailed prohibitions and/or restrictions on certain data transfers to certain named countries

or individuals.

So far, those countries include China (including Hong Kong and Macao), Cuba, Iran, North Korea, Russia, and Venezuela.

While the Final Rule is subject to enforcement by the DOJ and Attorney General, private litigants have cited violations of the rule in

their state UDAP claims.

In addition to the FTC Act

states have unfair and deceptive acts and practices statutes, known as UDAP statutes, that are substantively similar to the

FTC Act and have been applied in the privacy and data security context.

These UDAP statutes vary in substance and strength from state

and other federal laws/rules, many U.S.

states have unfair and deceptive acts and practices statutes, known as UDAP statutes, that are

substantively similar to the FTC Act and have been applied in the privacy and data security context.

These UDAP statutes vary in substance

and strength from state to state.

Many have broad prohibitions against unfair and deceptive acts and practices.

These statutes generally allow for private rights

of action, and are enforced by the states’ Attorneys General.

More than a dozen states

These statutes generally

allow for private rights of action and are enforced by the states’ Attorneys General.

More than twenty states

have adopted comprehensive consumer privacy laws that are in effect or will take effect within the next 12 to 24 months, and regulate

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measures to safeguard the personal information that is collected and regulate categories of “sensitive” data such as information

associated with minors, citizenship, and other personal data for which these state laws have designated special protection.

do not, however, apply to personal information that constitutes PHI under HIPAA, de-identified data as defined under HIPAA or in some

instances, HIPAA-regulated entities.

As a result, we do not or likely will not have compliance obligations with respect to most testing

and patient information we collect and process.

However, we are required to comply with these consumer privacy laws insofar as we collect

other categories of consumers’ personal information, for example from website visitors.

These state consumer privacy laws are generally

enforced by the respective state Attorney General.

California’s law also includes a private right of action for certain data breaches.

associated with minors, citizenship, consumer-generated health information (outside of HIPAA-covered PHI), and other personal data for

which these state laws have designated special protection.

These laws do not, however, apply to personal information that constitutes

PHI under HIPAA, de-identified data as defined under HIPAA or in some instances, HIPAA-regulated entities.

As a result, we do not or likely

will not have compliance obligations with respect to most testing and patient information we collect and process.

However, we are required

to comply with these consumer privacy laws insofar as we collect other categories of consumers’ personal information, for example

from website visitors.

These state consumer privacy laws are generally enforced by the respective state Attorney General.

law also includes a private right of action for certain data breaches.

Washington State has passed

the My Health My Data Act or MHMDA, which comes into effect on March 31, 2024.

the My Health My Data Act or MHMDA, which came into effect on March 31, 2024.

MHMDA regulates consumer health data that is not otherwise

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Should the company become subject to an action brought under MHMDA, it could have an impact on our operations.

and Connecticut has passed substantially similar consumer privacy health laws that have or will come into effect in 2024.

Nevada and Connecticut laws do not include a private right of action.

Dozens of other states in

the United States are currently considering similar, consumer data privacy laws, which could impact our operations if enacted.

and Connecticut have passed substantially similar consumer privacy health laws that came into effect in 2024 and 2023, respectively.

the Nevada and Connecticut laws do not include a private right of action.

Certain state laws, including

biometric and genetic privacy statutes, may impose additional requirements beyond HIPAA with respect to the collection, storage, and use

of genetic information.

Some of these statutes include private rights of action, which may increase litigation risk.

Dozens of other states

in the United States are currently considering similar, consumer data privacy laws, which could impact our operations if enacted.

Healthcare Reform

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Medicare reimbursement programs are complex

and often ambiguous and are continuously being evaluated and modified by the Centers for Medicare and Medicaid Services (CMS).

to receive timely reimbursements from third-party payers is dependent on our ability to submit accurate and complete billing statements,

and/or correct and complete missing and incorrect billing information.

Missing and incorrect information on reimbursement submissions

slows down the billing process and increases the aging of accounts receivable.

We must bill Medicare directly for tests performed for

Medicare patients and must accept Medicare’s fee schedule for the covered tests as payment in full.

State Medicaid programs are

generally prohibited from paying more than the Medicare fee schedule.

and often ambiguous and are continuously being evaluated and modified by CMS.

Our ability to receive timely reimbursements from third-party

payers is dependent on our ability to submit accurate and complete billing statements, and/or correct and complete missing and incorrect

billing information.

Missing and incorrect information on reimbursement submissions slows down the billing process and increases the aging

of accounts receivable.

We must bill Medicare directly for tests performed for Medicare patients and must accept Medicare’s fee

schedule for the covered tests as payment in full.

State Medicaid programs are generally prohibited from paying more than the Medicare

fee schedule.

Since 2021, we have been contracted with XIFIN, Inc.

a healthcare billing services management company, to help manage our third-party billing.

(“XIFIN”), a healthcare billing services management company,

to help manage our third-party billing.

Some billing arrangements

require us to bill multiple payers, and there are several other factors that complicate billing (e.g., disparity in coverage and information

requirements among various payers;

and incomplete or inaccurate billing information provided by ordering physicians).

Several private

payers have implemented pre-authorization requirements for molecular and genetic testing, including Anthem Blue Cross Blue Shield and

United Healthcare, as well as various lab benefit companies such as American Imaging Management, Inc., or AIM, and Beacon Lab Benefits

Solutions, or Beacon.

In addition, more commercial payers are contracting with and delegating risk for lab services costs to lab benefits

management companies (e.g.

requirements among various payers and incomplete or inaccurate billing information provided by ordering physicians).

Several private payers

have implemented pre-authorization requirements for molecular and genetic testing, including Anthem Blue Cross Blue Shield and United

Healthcare, as well as various lab benefit companies such as American Imaging Management, Inc., or AIM, and Beacon Lab Benefits Solutions,

In addition, more commercial payers are contracting with and delegating risk for lab services costs to lab benefits management

companies (e.g.

eviCore healthcare, AIM, and Beacon).

This requires us to go through their technology assessment process to

secure coverage and obtain a contract as an in-network lab provider for our services.

We incur additional costs as a result of our participation

in Medicare and Medicaid programs because diagnostic testing services are subject to complex, stringent and frequently ambiguous federal

and state laws and regulations, including those relating to coverage, billing and reimbursement.

Additionally, auditing for compliance

with applicable laws and regulations as well as internal compliance policies and procedures adds further cost and complexity to the billing

Further, our billing systems require significant technology investment and, as a result of marketplace demands, we need to continually

invest in our billing systems.

Changes in laws and regulations could further complicate our billing and increase our billing expense.

CMS establishes procedures and continuously evaluates and implements changes to the reimbursement process and requirements for coverage.

This requires us to go through their technology assessment process to secure coverage

and obtain a contract as an in-network lab provider for our services.

Laboratory benefit managers may require separate technology assessments,

prior authorization protocols, or contractual arrangements as a condition of coverage.

Failure to obtain or maintain approval could materially

reduce test volume.

We also incur additional costs as a result of our participation in Medicare and Medicaid programs because diagnostic

testing services are subject to complex, stringent and frequently ambiguous federal and state laws and regulations, including those relating

to coverage, billing and reimbursement.

Additionally, auditing for compliance with applicable laws and regulations as well as internal

compliance policies and procedures adds further cost and complexity to the billing process.

Further, our billing systems require significant

technology investment and, as a result of marketplace demands, we need to continually invest in our billing systems.

Changes in laws and

regulations could further complicate our billing and increase our billing expense.

CMS establishes procedures and continuously evaluates

and implements changes to the reimbursement process and requirements for coverage.

As an integral part of our

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may not provide adequate reimbursement rates, if covered.

Further, one payer’s determination to provide coverage does not assure

Further, one payer’s determination to provide coverage does not ensure

that other payers will also provide coverage for the test.

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Certain Medicaid programs require Medicaid recipients to pay co-payment amounts for diagnostic information services.

The Medicare Part

B program contains fee schedule payment methodologies for clinical testing services performed for covered patients.

Historically, the

Medicare Clinical Laboratory Fee Schedule, or CLFS, has been subject to local variations in pricing.

The Medicare Part B program

contains fee schedule payment methodologies for clinical testing services performed for covered patients.

CMS publishes annual updates

to the Clinical Laboratory Fee Schedule, or CLFS, which is subject to local variations in pricing.

In April 2014, President Obama signed

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from such 6-month period (January 1 through June 30 in the applicable year) to CMS between January 1 through March 31 of the following

CMS posted the first new Medicare CLFS rates (based on weighted median private payer rates) in November 2017 and the new rates

became effective on January 1, 2018.

Payment reductions based on PAMA-derived rates have been implemented for applicable tests and may continue through 2027 subject to

statutory caps and any further legislative modification.

Congress and CMS have continued to take legislative and administrative action

that may delay, modify, or otherwise affect PAMA reporting and CLFS implementation, which may affect future payment rates for our tests.

PAMA, as amended by the Protecting

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approved Clinical Diagnostic Laboratory Tests (“CDLTs”) that are not Advanced Diagnostic Laboratory Tests.

Under these laws,

the next data reporting period is January 1, 2025 through March 31, 2025, and will be based upon the data collected during the January

1, 2019 to June 30, 2019 period.

Any reductions to payment rates resulting from the new methodology are limited to 10% per test per year

in each of the years 2018 through 2020 and to 15% per test per year in each of the years 2025 through 2027.

Payments will not be reduced

for 2021through 2024 for CDLTs.

The most recent

data reporting period concluded on March 31, 2025 and was based on the data collected from January 1, 2019 through June 30, 2019.

reductions to payment rates resulting from the new methodology are limited to 10% per test per year in each of the years 2018 through

2020 and to 15% per test per year in each of the years 2025 through 2027.

Payments will not be reduced for 2021through 2024 for CDLTs.

Under the revised Medicare

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offering Medicare Advantage plans and of beneficiary enrollment in these plans.

Commercial health plans that

might not cover one or all of our tests for their commercially insured members are required to follow the Novitas LCD coverage policy

for their Medicare Advantage members.

To the extent we maintain the LCD coverage policies with Novitas for our products, any shift of

members from traditional Medicare to Medicare Advantage plans does not represent a risk of lost revenue.

In recent years, in an effort

to control costs, states also have mandated that Medicaid beneficiaries enroll in private managed care arrangements.

Medicare Advantage plans

generally must provide coverage at least as favorable as Original Medicare for items and services covered by Original Medicare, but such

plans may impose utilization management, prior authorization, network or other coverage restrictions.

Local coverage determinations and

Medicare Administrative Contractor policies (including LCDs issued by Novitas) are influential in determining coverage for Medicare beneficiaries,

but Medicare Advantage plans and commercial payers may impose additional requirements that affect utilization and reimbursement.

extent we maintain the LCD coverage policies with Novitas for our products, any shift of members from traditional Medicare to Medicare

Advantage plans does not represent a risk of lost revenue.

In recent years, in an effort to control costs, states also have mandated that

Medicaid beneficiaries enroll in private managed care arrangements.

The current position of our

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of the law is now or will be in the future consistent with government guidance and interpretation.

Changes in regulatory interpretation

or the classification of laboratory developed tests as medical devices could alter this analysis and subject us to reporting obligations,

including as a result of future FDA rulemaking or legislation.

In December 2019, our Medicare

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Effective January 1, 2023, the gapfill price for ThyGeNEXT ® was set at $1,266.07.

Novitas LCD for PancraGEN

On June 5, 2023 we announced

that Novitas issued the final LCD of Genetic Testing for Oncology (L39365) which, if implemented, would have established non-coverage

for the Company’s widely used PancraGEN ® test effective July 17, 2023.

On July 6, 2023, Novitas announced that it

would not be implementing the final Genetic Testing for Oncology LCD (L39365) as scheduled on July 17, 2023.

Novitas then issued a new,

virtually identical proposed LCD affecting the same companies and tests and reaching the same conclusions as noted in the previously rescinded

LCD on July 27, 2023.

In response, we participated in a public meeting presentation and submitted detailed written comments supporting

the use of PancraGEN ® .

The timing and content of any final, implemented LCD was uncertain at that time.

As a result, we

are able to continue offering PancraGEN ® and the related Point2 ® fluid chemistry tests for amylase, CEA,

and glucose throughout 2024.

On January 9, 2025, the Company announced the new LCD established non-coverage for its PancraGEN ®

test, and it would stop offering the test and would not accept specimens for first-line fluid chemistry and PancraGEN ® testing

after February 7 th , 2025.

On January 27, 2025, the Company announced that CMS had directed its MACs, Novitas and First Coast

Service Options, Inc., to delay implementation of the Genetic Testing for Oncology LCD (L39365), from February 23, 2025 until April 24,

The Company stated that this change of effective date will allow the Trump Administration time to fully review the proposed policy

changes, re-evaluate for themselves the supporting clinical evidence for the PancraGEN ® assay, and fully assess the negative

impact on patient care if the currently proposed LCD comes into effect.

In the event Novitas ultimately restricts coverage for the PancraGEN ®

test, our liquidity could be negatively impacted.

Reporting Segments

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which is the business of developing and selling diagnostic clinical services.

As of March 21, 2025, we

had 111 full time employees and 111 total employees.

As of March 2, 2026, we had

102 full time employees and 102 total employees.

We are not party to a collective bargaining agreement with any labor union.

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Series C Preferred Stock Investment by 1315

Capital and Ampersand

October 10, 2024, the Company, Ampersand 2018 Limited Partnership (“Ampersand”) and 1315 Capital II, L.P.

(“1315 Capital

and, together with Ampersand, the “Investors”) entered into an Exchange Agreement (the “Exchange Agreement”) pursuant

to which the Company exchanged (the “Exchange”) an aggregate of 47,000 shares of the Company’s existing Series B convertible

Capital and Ampersand and Conversion into Common Stock

On October 10, 2024, the

Company, Ampersand 2018 Limited Partnership (“Ampersand”) and 1315 Capital II, L.P.

(“1315 Capital” and, together

with Ampersand, the “Investors”) entered into an Exchange Agreement (the “Exchange Agreement”) pursuant to which

the Company exchanged (the “Exchange”) an aggregate of 47,000 shares of the Company’s existing Series B convertible

preferred stock of the Company, par value $0.01 per share (the “Series B Preferred Stock”), comprised of 28,000 shares of

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In the Exchange, Ampersand received 28,000 shares of Series C Preferred Stock and 1315 received 19,000 shares of Series C Preferred Stock.

Series C Preferred Stock is convertible into the Company’s common stock, par value $0.01 per share (the “Common Stock”)

at a conversion price of $2.02 per share of Common Stock (subject to further adjustment in the event of any stock dividend, stock split,

combination, or other similar recapitalization affecting such shares) (the “Series C Conversion Price”) which was the closing

price of the Common Stock on the date of the Exchange Agreement.

The Series C Preferred Stock does not have a liquidation preference over

the Common Stock in the event of a sale or dissolution of the Company, does not have director designation rights and includes limited

customary protective provisions.

The Series B Preferred Stock had a conversion price of $6.00 per share of Common Stock and included additional

protective provisions not applicable to the Series C Preferred Stock, including (i) limitations on the Board of Directors of the Company

(the “Board”) to declare dividends, (ii) director designation rights for each of the Investors, (iii) liquidation rights of

holders upon “deemed liquidation” events, including a liquidation preference over the Common Stock, (iv) limitations on the

ability to authorize, issue or create debt securities, (v) limitations on the ability to enter into mergers or acquisitions and (vi) limitations

on the ability to conduct public offerings of the Company’s Common Stock.

closing of the transactions contemplated by the Exchange Agreement occurred on October 11, 2024 following the satisfaction of customary

conditions set forth in the Exchange Agreement and did not result in the receipt of any cash proceeds by the Company.

Certificate of Designation

of Series C Convertible Preferred Stock

connection with the Exchange, on October 11, 2024, the Company filed a Certificate of Designation of Preferences, Rights and Limitations

of Series C Convertible Preferred Stock (the “Certificate of Designation”), with the Secretary of State of the State of Delaware.

Each capitalized term used herein and not otherwise defined shall have the meaning ascribed to it in the Certificate of Designation.

any matter presented to the stockholders of the Company for their action or consideration at any meeting of stockholders of the Company

(or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Series C Preferred Stock will be entitled

to cast the number of votes equal to the number of whole shares of Common Stock, into which the shares of Series C Preferred Stock held

by such holder are convertible as of the record date for determining stockholders entitled to vote on such matter.

Except as provided

by law or by the Certificate of Designation, holders of Series C Preferred Stock will vote together with the holders of Common Stock as

a single class and on an as-converted to Common Stock basis.

Certificate of Designation provides that from and after the Issuance Date and subject to the terms of the Certificate of Designation,

each share of Series C Preferred Stock is convertible, at any time and from time to time, at the option of the holder into a number of

shares of Common Stock equal to the product of the Series C Conversion Ratio (the “ Series C Conversion Ratio ”) and

the number of shares of Series C Preferred Stock to be converted.

The Series C Conversion Ratio is calculated by dividing the Stated Value

per share of Series C Preferred Stock by the Series C Conversion Price.

The Series C Conversion Ratio is subject to adjustment in the

event of any stock dividend, stock split, combination, or other similar recapitalization which results in the adjustment of the Series

C Conversion Price.

aggregate number of shares of Common Stock that may be issued through conversion of all of the Exchange Shares is 23,267,326 shares (subject

to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization affecting such

Mandatory Conversion

prior to the Company’s listing of Common Stock on The Nasdaq Stock Market, all outstanding shares of Series C Preferred Stock shall

automatically convert into a number of shares of Common Stock equal to the product of the Series C Conversion Ratio and the number of

shares of Series C Preferred Stock owned by each holder.

Certificate of Designation does not provide for mandatory dividends on the Series C Preferred Stock.

Dividends may be declared and paid

on the Series C Preferred Stock from funds lawfully available and as determined by the Board.

Protective Provisions

so long as any shares of Series C Preferred Stock are outstanding, the written consent of each holder of the then outstanding shares of

Series C Preferred Stock is required for the Company or its subsidiaries to (i) amend, waive, alter or repeal the preferences, rights,

privileges or powers of the holders of the Series C Preferred Stock, (ii) amend, alter or repeal any provision of the Certificate of Designation

in a manner adverse to the holders of the Series C Preferred Stock or (iii) authorize, create or issue any equity securities senior to

or pari passu with the Series C Preferred Stock.

any voluntary or involuntary liquidation, dissolution or winding up of the Company, the holders of shares of Series C Preferred Stock

then outstanding will be entitled to be paid out of the assets of the Corporation available for distribution to its stockholders on a

pari passu basis with the holders of the Common Stock of the Company.

Amended and Restated

Investor Rights Agreement

connection with the Exchange, on October 10, 2024, the Company and the Investors entered into an amended and restated investor rights

agreement (the “Amended and Restated Investor Rights Agreement”), which amended and restated that certain Amended and Restated

Investor Rights Agreement, dated as of January 15, 2020, among the Company and the Investors (the “Prior Investor Rights Agreement”).

Pursuant to the Amended and Restated Investor Rights Agreement, the Company and the Investors established certain terms and conditions

concerning the rights of and restrictions on the Investors with respect to the ownership of the Series C Preferred Stock of the Company.

Amended and Restated Investor Rights Agreement provides the Investors with (1) demand registration rights exercisable beginning on the

date of the Closing and subject to certain limitations described therein, (2) piggy-back registration rights at any time the Company proposes

to file a registration statement under the Securities Act, with respect to an offering of equity securities, or securities or other obligations

exercisable or exchangeable for, or convertible into, equity securities, subject to certain exceptions described therein, and (3) shelf

registration rights.

On January 20, 2026,

the Company announced that all shares of Series C Preferred Stock have been converted into common stock, resulting in the issuance of

approximately 23,267,327 shares of Interpace common stock (calculated as $1,000 stated value per preferred share divided by the $2.02

conversion price).

Of this amount, 1315 Capital

owns approximately 9,405,941 shares of common stock, or approximately 34% of Interpace’s outstanding common stock, and Ampersand

owns 13,861,386 shares of common stock, or approximately 50% of Interpace’s outstanding common stock, in both cases subject to change

in connection with subsequent issuance activity and public float changes.

Available Information

6 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business