New Publication Establishes Strong Clinical Validation of Signatera™ for MRD Assessment in Lymphoma

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Signatera demonstrates 100% positive predictive value for treatment response assessment, detects recurrence months earlier than imaging, and supports precise, individualized lymphoma management through serial ctDNA monitoring

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of new data in Blood Neoplasia, validating the prognostic and predictive value of Signatera in patients with both newly diagnosed and relapsed/refractory (R/R) lymphoma.

PET/CT scans serve as the standard tool for assessing treatment response in lymphoma, but their performance is limited, with positive predictive value (PPV) reported as low as 50% and negative predictive value (NPV) as low as 80%.^1-3 To address this unmet need, the National Comprehensive Cancer Network^® (NCCN^®) guidelines were recently updated to include circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) assessment as a confirmatory method for positive PET/CT scans.

The prospective, real-world study conducted by Galanina et al. evaluated a representative cohort of 144 newly diagnosed or R/R patients across 14 distinct indolent and aggressive lymphoma subtypes, with analysis of 1,105 plasma samples collected at baseline, during therapy, at the end of therapy (EOT), and throughout surveillance. Signatera status was compared to standard-of-care imaging and clinical outcomes to evaluate its predictive and prognostic utility in real-world disease management. Key findings include:

• Superior prognostic ability over PET/CT:
  • EOT Signatera-positivity was prognostic of significantly inferior event-free survival (EFS) (adj HR: 45.33; p<0.0001) and was the strongest independent predictor of EFS in a multivariate analysis (HR: 80.83 vs. PET/CT HR: 5.18; p<0.001).
  • Signatera demonstrated superior PPV vs. PET/CT at EOT (100% vs. 62%; p<0.0001). Among discordant ctDNA/PET cases, the Signatera test result was confirmed as correct in 85% of instances.
  • During surveillance, Signatera-positivity was strongly prognostic (HR: 33.74; p<0.0001), demonstrating a sensitivity of 91% and specificity of 92%.
• Predictive of response across the treatment continuum:
  • Signatera clearance during 1L therapy was associated with significantly improved EFS (adj HR: 8.57; p=0.0005).
  • For R/R patients post CAR-T therapy, Signatera clearance was associated with durable remission, while Signatera-positive patients experienced disease progression or death, and a median durable treatment interval of 16.1 vs. 1.97 months, respectively (p=0.0091).

“Lymphoma is an incredibly diverse group of cancers and this study shows that Signatera delivers consistent and reliable insights across multiple lymphoma subtypes,” said Natalie Galanina, M.D., corresponding author of the study. “Findings suggest that Signatera can complement traditional imaging by identifying patients who may benefit from earlier changes in management. ctDNA/MRD assessment is transforming how we evaluate treatment response, offering the opportunity to move beyond conventional imaging and toward more precise, individualized, and dynamic treatment decisions. I’m excited to incorporate this approach into routine clinical practice to further personalize care for patients with hematologic malignancies.”

“The ability to reliably detect and monitor molecular residual disease over time has the potential to impact the approach to treatment of lymphoma,” said Minetta Liu, M.D., chief medical officer, oncology and early cancer detection, Natera. “By enabling visibility into recurrence earlier than imaging, Signatera testing creates a window for more timely, risk-adapted interventions that could meaningfully change patient management.”

References

1. Kostakoglu L, Martelli M, Sehn LH, et al. End-of-treatment PET/CT predicts PFS and OS in DLBCL after first-line treatment: results from GOYA. Blood Advances. 2021;5(5):1283-1290. doi:10.1182/bloodadvances.2020002690.
2. Roschewski, Mark, et al. “Circulating Tumor DNA as Measurable Residual Disease in Aggressive B-Cell Lymphoma: A Narrative Review.” JAMA Oncology, vol. 11, no. 4, 2025, pp. 416–422.
3. Adams HJA, Nievelstein RAJ, Kwee TC. Prognostic value of complete remission status at end-of-treatment FDG-PET in R-CHOP-treated diffuse large B-cell lymphoma: systematic review and meta-analysis. British Journal of Haematology. 2015;170(2):185-191. doi:10.1111/bjh.13420.

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, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in 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/20260828724062/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

positive predictive value medical

Positive predictive value is a measure of how likely it is that a positive result actually indicates a true positive. For investors, it helps assess how reliable a signal or indicator is in predicting real opportunities or risks, similar to how knowing that a weather forecast predicts rain accurately helps you decide whether to carry an umbrella. A higher positive predictive value means greater confidence that a positive signal truly reflects a meaningful event.

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.

circulating tumor DNA medical

Fragments of DNA shed by cancer cells into the bloodstream that act like tiny fingerprints of a tumor; they can be detected with a blood test rather than a biopsy. Investors care because circulating tumor DNA (ctDNA) enables faster, lower-cost ways to detect disease, track treatment response, identify emerging resistance and enroll patients in trials—factors that can materially affect the commercial prospects of diagnostics and therapeutics.

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.

event-free survival medical

Event-free survival measures the length of time after a treatment or diagnosis during which a patient does not experience a predefined negative outcome, such as disease progression, relapse, or death. For investors, longer event-free survival in clinical trials signals that a therapy may be effective and durable, improving its chances of regulatory approval and commercial success — think of it like a warranty period before problems reappear.

multivariate analysis technical

A statistical approach that examines several variables at once to see how they relate to each other and to an outcome, such as returns, risk, or sales. For investors it helps separate the influence of different factors—like market trends, company size, or interest rates—so you can identify which ones drive performance and make more informed forecasts and risk assessments. Think of it as tasting a stew to judge which ingredients matter most to the final flavor.