Natera Announces Commercial Payor Coverage for Signatera™

Rhea-AI Summary

Natera, Inc. (NASDAQ: NTRA) has announced significant advancements in commercial coverage for its Signatera molecular residual disease test. Effective March 1, 2023, Blue Shield of California will cover Signatera for all solid tumor patients, marking the company's first pan-cancer policy. Additionally, as of January 1, 2023, Blue Cross and Blue Shield of Louisiana will provide coverage for colorectal and bladder cancer monitoring. This underscores the medical necessity and enhanced access to Signatera testing, which has been validated through approximately 40 peer-reviewed publications for its efficacy in detecting cancer recurrence earlier than traditional methods.

Positive

• First commercial coverage for Signatera by Blue Shield of California effective March 1, 2023.
• Pan-cancer coverage policy for adjuvant and recurrence monitoring announced.
• Coverage for colorectal and muscle invasive bladder cancer monitoring from Blue Cross and Blue Shield of Louisiana effective January 1, 2023.
• Signatera supported by approximately 40 peer-reviewed publications validating its clinical utility.

Negative

• None.

Pan-cancer policy from Blue Shield of California covers adjuvant, recurrence monitoring, and treatment monitoring

Multi-cancer policy from BCBS of Louisiana covers CRC, Bladder, and IO monitoring

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced the Company’s first commercial coverage policies for its molecular residual disease test, Signatera, including its first pan-cancer coverage policy for adjuvant, recurrence monitoring, and treatment monitoring.

Effective March 1, 2023, Blue Shield of California now provides commercial coverage of Signatera for plan members diagnosed with any solid tumors. Specifically, the policy describes tumor-informed ctDNA testing with Signatera as medically necessary for patients with stage I-IV cancer to provide information for (1) adjuvant or targeted therapy; and/or (2) monitoring for relapse or progression, including but not limited to the use of immunotherapy.

In addition, effective January 1, 2023, Blue Cross and Blue Shield of Louisiana is providing coverage of serial testing with Signatera for plan members diagnosed with colorectal and muscle invasive bladder cancer and for pan-cancer immunotherapy monitoring.

“Following the recent breast cancer coverage decision by Medicare, achieving our first commercial coverage policies for Signatera – including one that encompasses pan-cancer coverage – is another major milestone for Natera and the patients who will now have enhanced access to tumor-informed ctDNA testing,” said John Fesko, chief business officer. “These developments underscore the medical necessity of Signatera to inform critical treatment decisions and detect recurrence earlier.”

Data supporting the clinical validity and utility of Signatera has been published in approximately 40 peer-reviewed publications, including validation across multiple cancer types to detect recurrence earlier than standard diagnostic tools^1,2 and to improve the assessment of treatment response in conjunction with imaging.³

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual's tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.

About Natera

Natera™ is a global leader in cell-free DNA testing, 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 validated by more than 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. 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 our expectations of the reliability, accuracy and performance of our tests, or our expectations 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.

References

1. Reinert T, Henriksen TV, Christensen E, et al. Analysis of plasma cell-free DNA by ultradeep sequencing in patients with stages I to III colorectal cancer. JAMA Oncol. 2019;5(8):1124–1131.
2. Coombes RC, Page K, Salari R, et al. Personalized detection of circulating tumor DNA antedates breast cancer metastatic recurrence. Clin Cancer Res. 2019;25(14):4255-4263.
3. Bratman SV, Yang SYC, Iafolla MAJ, et al. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat. Cancer. 2020;1(9):873-881.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230302005332/en/

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com

Media: Lesley Bogdanow, Vice President, Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.

FAQ

What is the significance of Natera's announcement regarding Signatera?

Natera's announcement marks the first commercial coverage policies for Signatera, enhancing access for patients with solid tumors and demonstrating the test's medical necessity.

When did Blue Shield of California start covering Signatera?

Blue Shield of California began covering Signatera effective March 1, 2023.

What types of cancer are covered under Blue Cross and Blue Shield of Louisiana's policy for Signatera?

The coverage under Blue Cross and Blue Shield of Louisiana includes colorectal and muscle invasive bladder cancer.

How does Signatera improve cancer treatment monitoring?

Signatera enables earlier detection of cancer recurrence and helps optimize treatment decisions, supported by extensive clinical validation.

What is the ticker symbol for Natera, Inc.?

The ticker symbol for Natera, Inc. is NTRA.