Signatera™ in Head and Neck Cancer: Three New Publications Demonstrate Strong Clinical Performance and Actionability

The studies evaluated chemotherapy benefit and recurrence surveillance in both HPV-positive and HPV-negative head and neck cancer.

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Findings show Signatera’s predictive and prognostic abilities in a cancer that carries recurrence rates of up to 60%, along with excellent performance of the test in both HPV-positive and HPV-negative subtypes

AUSTIN, Texas--(BUSINESS WIRE)--

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced three peer-reviewed publications in npj Precision Oncology, JAMA Otolaryngology, and Advances in Radiation Oncology, highlighting the performance of its Signatera test in head and neck squamous cell carcinoma (HNSCC).

HNSCC carries recurrence rates of up to 60% depending on stage, and traditional surveillance modalities (e.g., imaging) are limited by high rates of false-positive results and low sensitivity.^1-3 Human papillomavirus (HPV) can be a major driver of HNSCC and defines two distinct forms of the disease, HPV-positive (HPV+) and HPV-negative (HPV-).

npj Precision Oncology
In an institutional cohort study, patients were prospectively tested with Signatera after curative-intent surgical resection. Key findings included:

• Predictive benefit: Post-operative, pre-adjuvant Signatera-status was predictive of adjuvant chemotherapy benefit in mucosal HNSCC. Among Signatera-positive patients, chemotherapy was associated with a 35% absolute reduction in 2-year locoregional recurrence (28.6% vs. 63.3% without). Signatera-negative patients saw no difference in disease-free survival (DFS), locoregional recurrence, and distant metastases, regardless of adjuvant chemotherapy treatment.
• Outperformed high-risk factors: Signatera outperformed clinicopathologic risk factors for prognostication of disease free survival risk.

JAMA Otolaryngology
In this study of 168 patients, Signatera was evaluated in the pre-treatment and surveillance settings, with the following key findings:

• High baseline detection of molecular residual disease (MRD): 92.2% of pre-treatment samples were Signatera-positive.
• Strong MRD performance across HPV+ and HPV- patients: Serial Signatera testing showed 95.2% sensitivity and 99.4% negative predictive value, with 100% specificity and 100% positive predictive value in the surveillance setting.

Advances in Radiation Oncology
In a retrospective analysis of 97 patients with stage 1-4 HNSCC, key findings on Signatera’s clinical utility during post-definitive treatment surveillance included:

• Advance detection of recurrence over imaging: Serial Signatera testing detected recurrence by a median of 4.3 months before radiographic progression, with 91.7% sensitivity and 96.4% specificity.
• Excellent MRD performance across HPV+ and HPV- subtypes: Signatera achieved 100% sensitivity in HPV+ patients, outperforming TTMV-HPV DNA assays commonly used to detect recurrence in this patient population.⁴
• Multivariate analysis: Signatera-positivity was the only independent predictor of progression-free survival in a multivariate analysis, outperforming clinical stage, p16 status, and tumor location.

“Head and neck cancer is difficult to treat and carries high recurrence rates, underscoring the importance of catching relapse as early as possible,” said Michael Krainock, MD, PhD, MBA, Medical Director, Oncology, Natera. “Collectively, these new studies demonstrate Signatera’s ability to detect recurrence well in advance of clinical signs and predict which patients were likely to benefit from adjuvant chemotherapy.”

References

1. Hulse K, Hurley R, Lowit A, Maguire R, Paterson C, Douglas CM. Patient-reported symptoms in the detection of head and neck cancer recurrence: a systematic review. Front Oncol. 2025;15:1632592
2. NCCN Clinical Practice Guidelines in Oncology. Head and Neck Cancers. V2.2026
3. Isles, M.G., McConkey, C. and Mehanna, H.M. (2008), A systematic review and meta-analysis of the role of positron emission tomography in the follow up of head and neck squamous cell carcinoma following radiotherapy or chemoradiotherapy. Clinical Otolaryngology, 33: 210-222. https://doi.org/10.1111/j.1749-4486.2008.01688.x.
4. Ferrandino RM, Chen S, Kappauf C, et al. Performance of Liquid Biopsy for Diagnosis and Surveillance of Human Papillomavirus–Associated Oropharyngeal Cancer. JAMA Otolaryngol Head Neck Surg. 2023;149(11):971–977. doi:10.1001/jamaoto.2023.1937

About Natera

Natera is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, San Carlos, California, and Boulder, Colorado. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

View source version on businesswire.com: https://www.businesswire.com/news/home/20261104932386/en/

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.

Key Terms

hnscc medical

HNSCC stands for head and neck squamous cell carcinoma, a type of cancer that starts in the flat lining cells that cover the surfaces of the mouth, throat and related structures. It matters to investors because treatments, clinical trial results, regulatory approvals or changes in diagnosis rates can directly affect the commercial prospects and valuation of companies developing therapies or diagnostics for this disease—think of it as a market signal tied to demand for specific medical products.

hpv medical

Human papillomavirus (HPV) is a family of common viruses that infect skin and mucous membranes; some types cause harmless warts while others can lead to precancerous changes and cancers such as cervical cancer. For investors, HPV matters because vaccines, diagnostic tests, screening programs, and treatments drive regulatory approvals, public health policy, and recurring revenue streams for healthcare companies—think of it as a prevalent health risk that creates ongoing demand for prevention and care products.

molecular residual disease medical

Molecular residual disease is the tiny amount of cancer that can remain in the body after treatment and is detectable only by sensitive tests that find cancer DNA or other molecular traces. It matters to investors because these measurements can predict relapse, guide whether additional therapy is needed, and shape the market for diagnostics and drugs—much like finding embers after a fire helps decide if more firefighting is required.

negative predictive value medical

Negative predictive value is a measure of how reliable a negative result is in confirming that a person or situation is truly free of a problem or condition. For investors, it indicates the likelihood that a negative signal or indicator truly means there is no risk or issue present, helping them assess how much trust to place in avoiding potential problems based on current information.

adjuvant chemotherapy medical

Adjuvant chemotherapy is drug treatment given after the main cancer therapy, usually surgery, to kill leftover cancer cells and lower the chance the disease will come back. For investors it matters because approval, clinical success or broader use of adjuvant therapy can expand a drug’s eligible patient pool, influence regulatory decisions and materially change sales and long‑term revenue—like a follow-up insurance policy that determines ongoing demand and value.