Naveris

Naveris

Molecular diagnostics for HPV-related cancers

Overview

Naveris develops and sells molecular diagnostic tests, including NavDx, a blood test that detects HPV-associated cancers (such as head and neck cancers) at an early stage, using blood and saliva samples for the detection of viral DNA/RNA linked to cancer. Its products are used by healthcare providers to aid early cancer detection and guide clinical management, and the company also pursues drug development and clinical trials as potential future revenue streams. Unlike some competitors that focus only on generic cancer screening, Naveris centers its offering on viral-associated cancers and leverages a noninvasive blood-based assay to identify cancer signal early, supporting oncologists and surgeons in decision-making. The company aims to transform cancer detection, drug development, and clinical trials by applying its diagnostic technology to improve patient outcomes and accelerate development pipelines.

About Naveris

Simplify's Rating
Why Naveris is rated
B
Rated A on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

Data & Analytics

Biotechnology

Healthcare

Company Size

51-200

Company Stage

Acquired

Total Funding

$69.9M

Headquarters

Waltham, Massachusetts

Founded

2017

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Simplify's Take

What believers are saying

  • Naveris reported about $35 million 2025 revenue, more than doubling year over year.
  • First-quarter 2026 revenue reached $12 million with 65% gross margins and breakeven losses.
  • Over 130,000 commercial tests and 2023 Medicare coverage support repeat-use adoption.

What critics are saying

  • NavDx remains a CLIA laboratory-developed test with no FDA clearance or approval.
  • Guardant, Natera, and tumor-informed MRD platforms can take oncology surveillance share.
  • A Medicare rate cut or coverage reversal would crater Naveris revenue overnight.

What makes Naveris unique

  • NavDx is the only Medicare-covered MRD assay for HPV-positive head and neck and anal cancers.
  • CareDx closed Naveris on July 1, 2026, paying $161.8 million upfront.
  • The platform uses tumor tissue-modified viral DNA, avoiding tissue dependence and broadening surveillance.

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Funding

Total Funding

$69.9M

Above

Industry Average

Funded Over

4 Rounds

Acquisition funding comparison data is currently unavailable. We're working to provide this information soon!
Acquisition Funding Comparison
Coming Soon

Benefits

Remote Work Options

Growth & Insights and Company News

Headcount

6 month growth

2%

1 year growth

1%

2 year growth

0%
MD+DI
May 4th, 2026
CareDx acquires liquid biopsy firm Naveris for up to $260M.

CareDx acquires liquid biopsy firm Naveris for up to $260M. The deal comes on the heels of CareDx divesting its Lab Products business to EuroBio Scientific for $170 million. Omar Ford, Editor-in-Chief, MD+DI, Informa Markets - Engineering May 4, 2026 CareDx is diving deeper into the oncology space with the acquisition, nearly a month after the company shed its Lab Products business to EuroBio Scientific. The deal, which is expected to close in 3Q26, calls for an upfront cash payment of $160 million, with the potential for an additional $100 million in milestones. Waltham, MA-based Naveris has developed blood-based tests that monitor for signs of rejection after kidney, heart, and lung transplantation. The company has also developed NavDx, a liquid biopsy test that can detect human papillomavirus (HPV)-driven cancers earlier and with greater accuracy than scans or traditional biopsies. Benefits of acquiring Naveris. CareDX said Naveris had an estimated 2025 revenue of $34 million and is expected to grow 30% to 40% annually for the next three years, neutral to CareDx's FY2026 Adjusted EBITDA guidance. "Naveris extends our platform into a large specialty oncology market where our model already applies and where we can lead," said John Hanna, President and CEO of CareDx, according to a Seeking Alpha transcript of the call. "It allows us to stay disciplined about where we compete, focusing on indications where molecular monitoring is differentiated and scalable. As we evaluated this opportunity, we were particularly focused on the long-term impact of our growth and returns to shareholders, and we have a strong conviction that this investment can deliver both within the framework of our existing operating model." Naveris employs about 100 individuals and has performed more than 130,000 commercial tests to date. The test received Medicare coverage in 2023 and is a leading solution in Head & Neck and Anal cancer MRD surveillance. "Naveris has developed and commercialized a liquid biopsy monitoring platform proven to detect cancer earlier and with greater accuracy than conventional approaches," said James B. McNally, CEO of Naveris. "We are thrilled to be combining forces with CareDx to fulfill our mission of improving patient outcomes by delivering disruptive technology that transforms cancer care and expanding patient access to precision medicine." Editor-in-Chief, MD+DI, Informa Markets - Engineering Omar Ford is a seasoned journalist specializing in medical technology, healthcare innovation, and the medical device and diagnostics industry. As the editor-in-chief of Medical Device + Diagnostics Industry (MD+DI), he has earned a reputation as a leading authority in the field, offering in-depth insights into the latest trends, regulatory changes, and technological advancements shaping the future of healthcare. Omar has been a featured speaker at MD&M and MEDevice events. Omar has written for several publications prior to MD+DI. He is a former contributor at Bioworld Medtech, an online publication owned by Clarivate. He was a general assignment reporter for the Beaufort Gazette and an education and county reporter for the Griffin Daily News. He is the 2001 winner of the Judson Chapman Award from the South Carolina Press Association and the 2003 McClatchy President's Award recipient. Omar has a bachelor's degree in print journalism from the University of South Carolina. Throughout his tenure at MD+DI, Omar has covered a wide array of topics, including medical technology innovations, regulatory affairs, market dynamics, and the growing impact of artificial intelligence in healthcare. Omar is the host of the Let's Talk Medtech podcast.

Citybiz
Apr 28th, 2026
CareDx to Acquire Naveris in $160M Deal Expanding Into Precision Oncology Testing

Under the terms of the deal, CareDx will pay $160 million in upfront cash consideration, with up to an additional $100 million tied to future revenue milestones. The companies said they expect the transaction to close in the third quarter of 2026, subject to customary conditions.

Business Wire
Apr 28th, 2026
CareDx announces agreement to acquire Naveris, A leader in viral-mediated cancer MRD surveillance testing.

CareDx announces agreement to acquire Naveris, A leader in viral-mediated cancer MRD surveillance testing. Transaction extends CareDx's Precision Medicine Testing Services strategy into specialty oncology with a Medicare-reimbursed commercial-stage MRD test and platform addressing a $4.5 Billion TAM Estimated 2025 Revenue of $34 Million is expected to grow 30-40% annually for the next three years and neutral to CareDx's FY2026 Adjusted EBITDA guidance BRISBANE, Calif.-(BUSINESS WIRE)-CareDx, Inc. (Nasdaq: CDNA) - The Transplant Company(TM), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced it has entered into a definitive agreement to acquire Naveris, a commercial stage precision oncology diagnostics company with a highly differentiated and Medicare-reimbursed, blood-based monitoring solution for viral-mediated cancers. The transaction is an extension of CareDx's strategy to focus on its U.S. Precision Medicine Testing Services and Patient and Digital Solutions. The definitive agreement provides for an up-front cash consideration of $160 million with up to an additional $100 million based on the achievement of revenue milestones. Naveris' highly differentiated liquid biopsy platform is based on Tumor Tissue Modified Viral (TTMV(R) DNA. The platform measures fragments of viral DNA released from tumor tissue into the bloodstream, serving as a highly accurate biomarker in human papillomavirus (HPV)-driven cancers. This tumor-naïve testing is designed to support the management of patients from diagnosis through post-treatment molecular residual disease (MRD) surveillance. Naveris reported unaudited revenue of $34 million in 2025, which we forecast to grow 30-40% annually for the next three years. For the first quarter of 2026, Naveris reported unaudited revenue of approximately $12 million, gross margins of 65% and net operating loss of $0.2 million. CareDx estimates the transaction will not impact its 2026 AEBITDA guidance and plans to provide further guidance following the close of the transaction. "Today's announcement accelerates our growth strategy in Precision Medicine Testing Services and Patient & Digital Solutions. We are focused on being a leader in concentrated specialty markets where a high burden of disease drives repeat testing. Naveris fits that profile with a differentiated technology that is early in its adoption," said John Hanna, President & CEO of CareDx. "Naveris is poised for strong growth, leveraging our core capabilities - building belief in molecular testing, simplifying clinical workflow, and generating evidence for coverage and reimbursement." Naveris employs approximately 100 individuals and has performed more than 130,000 commercial tests to date. The test received Medicare coverage in 2023 and is a leading solution in Head & Neck and Anal cancer MRD surveillance. "Naveris has developed and commercialized a liquid biopsy monitoring platform proven to detect cancer earlier and with greater accuracy than conventional approaches," said James B. McNally, Chief Executive Officer of Naveris. "We are thrilled to be combining forces with CareDx to fulfill our mission of improving patient outcomes by delivering disruptive technology that transforms cancer care and expanding patient access to precision medicine." The parties anticipate the transaction to close in the third quarter of 2026, subject to customary closing conditions. Goldman Sachs is acting as the exclusive financial advisor to CareDx in connection with the transaction. Fenwick & West is acting as legal advisor to CareDx. J.P. Morgan Securities LLC is acting as the exclusive financial advisor to Naveris in connection with the transaction. Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal advisor to Naveris. About CareDx CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company's integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com. About Naveris A portfolio company of B-FLEXION Life Sciences, Naveris is a privately held, commercial-stage precision oncology diagnostics company focused on improving outcomes for patients with viral-driven cancers. Founded in 2017, the Company develops and commercializes novel molecular diagnostics designed to enable earlier cancer detection and more personalized disease management. Naveris' proprietary NavDx(R) test is a clinically validated circulating tumor DNA blood test that detects tumor tissue-modified viral (TTMV(R) HPV DNA to support post-treatment surveillance and molecular residual disease (MRD) assessment in HPV-driven cancers. The Company operates high-complexity clinical laboratories in Massachusetts and North Carolina that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center and certified under CLIA. For more information, please visit www.naveris.com and www.NavDx.com. Forward Looking Statements This press release includes forward-looking statements related to CareDx including statements regarding the expected completion and timing of the acquisition, the anticipated impact of the transaction on CareDx's business, financial profile, and operating results, the benefits of the Naveris product, reimbursement coverage for the Naveris product, the achievement of CareDx's financial and operational goals and its expectations and prospects for 2026, the ability of CareDx to advance Naveris' platform technologies on a timely basis, if at all, the ability to satisfy all closing conditions and complete the transaction, difficulties or unanticipated expenses in connection with integrating the companies, and other statements that are not historical facts. These forward-looking statements are based on information currently available to CareDx and its current expectations, and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, the failure to obtain required regulatory approvals or satisfy closing conditions, delays in completing the transaction, general economic and market factors, and other risks discussed in CareDx's filings with the Securities and Exchange Commission (the "SEC"), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed by CareDx with the SEC on February 25, 2026, and other reports that CareDx has filed with the SEC. Any of these risks may cause CareDx's actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx's forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. More News From CareDx, Inc. BRISBANE, Calif.-( BUSINESS WIRE )-CareDx, Inc. (Nasdaq: CDNA) - The Transplant Company(TM), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Financial Highlights Revenue of $118 million, an increase of 39% year-over-year Testing services revenue of $91 m... BRISBANE, Calif.-( BUSINESS WIRE )-CareDx, Inc. (Nasdaq: CDNA) - The Transplant Company(TM), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced its participation at the International Society of Heart and Lung Transplantation (ISHLT) 2026 Annual Meeting, taking place April 22-25 in Toronto, Canada. The real-world clinical use and scient... BRISBANE, Calif.-( BUSINESS WIRE )-CareDx, Inc. (Nasdaq: CDNA) - The Transplant Company(TM), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today introduced AlloSeq Nano, a nanopore-based HLA (human leukocyte antigen) and ABO blood type genotyping solution, at the European Federation for Immunogenetics (EFI) Conference 2026. AlloSeq Nano is an inn... CareDx, Inc. NASDAQ:CDNA Release Versions

HealthTech HotSpot
Jan 9th, 2026
Naveris(R) to Highlight New Publications at the 44th Annual J.P. Morgan Healthcare Conference

Naveris(R) to highlight new publications at the 44th Annual J.P. Morgan Healthcare Conference. DURHAM, N.C. - (BUSINESS WIRE) - Naveris, Inc., the leader in precision oncology diagnostics for viral-driven cancers, today announced that it will be highlighting new data supporting the use of blood-based ctDNA tests to improve post-treatment surveillance protocols in both head-and-neck and anal cancers at the 44th Annual J.P. Morgan Healthcare Conference, to be held January 12-15, 2026, in San Francisco, CA. Recent data published in Cancers reinforces the value of the Naveris Tumor Tissue Modified Viral (TTMV(R) HPV DNA technology in the surveillance of anal squamous cell carcinoma (ASCC). The Company's flagship NavDx(R) test demonstrated high per-test positive predictive value (PPV) of 98% and negative predictive value (NPV) of 95% for recurrence detection in the surveillance setting. Additionally, NavDx helped resolve 92% of clinically indeterminate findings (CIFs).[i] These results reinforce the clinical utility of NavDx testing as part of a comprehensive surveillance protocol and align with recently expanded Medicare coverage for the use of NavDx in ASCC molecular residual disease (MRD) testing. "We are pleased to share significant business updates at the J.P. Morgan Healthcare Conference including our recently expanded Medicare coverage for NavDx in anal cancer MRD, new clinical data that reinforces the clinical utility of NavDx in anal cancer surveillance, and the impactful clinical consensus statement that highlights the utility of ctHPVDNA in head and neck cancer surveillance," commented James McNally, Chief Executive Officer of Naveris. Naveris management will present these updates on Wednesday, January 14, 2026 at 2:30 p.m. PT at the 44th Annual J.P. Morgan Healthcare Conference. Naveris is a privately held, commercial-stage precision oncology diagnostics company focused on improving outcomes for patients with viral-driven cancers. Founded in 2017, the Company develops and commercializes novel molecular diagnostics designed to enable earlier cancer detection and more personalized disease management. Naveris' proprietary NavDx(R) test is a clinically validated circulating tumor DNA blood test that detects tumor tissue - modified viral (TTMV(R) HPV DNA to support post-treatment surveillance and molecular residual disease (MRD) assessment in HPV-driven cancers. The Company operates high-complexity clinical laboratories in Massachusetts and North Carolina that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center and certified under CLIA. For more information, please visit www.naveris.com and www.NavDx.com.

Morningstar
Jan 10th, 2025
Naveris Announces Expansion of the NavDx(R) Test in Anal Cancer Molecular Residual Disease Surveillance

Naveris, Inc., the leader in precision oncology diagnostics for viral-induced cancers, today announced the expanded commercial availability of the NavDx test for Molecular Residual Disease (MRD) detection in anal squamous cell carcinoma (ASCC) patients.

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