Medicare Publishes Final Local Coverage Determination for Pan-Cancer Immunotherapy Monitoring with Natera's Signatera™ MRD Test

Rhea-AI Summary

Natera announced that the CMS has issued a final local coverage determination for pan-cancer immunotherapy monitoring using its Signatera molecular residual disease test. This coverage applies to Medicare patients undergoing immunotherapy, significantly expanding access to personalized monitoring. The Signatera test has shown high predictive accuracy in identifying non-responders early in treatment, aiming to improve cancer care outcomes. Natera sees this development as a crucial step in enhancing treatment decisions across various tumor types.

Positive

• Final LCD for Signatera test enhances coverage for pan-cancer immunotherapy monitoring.
• Signatera shows 100% positive predictive value for identifying treatment non-responders within six weeks.
• Expansion of personalized monitoring aligns with growing demand for precision medicine in oncology.

Negative

• None.

AUSTIN, Texas, Nov. 11, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a leader in personalized genetic testing, today announced that the CMS Molecular Diagnostics Services Program (MolDX) has issued a final local coverage determination (LCD) for pan-cancer immunotherapy monitoring using its Signatera molecular residual disease (MRD) test. An accompanying Billing and Coding Article, linked here, specifies that serial testing with Signatera is now covered for Medicare patients being treated with immunotherapy, regardless of tumor type. The final LCD is consistent with the draft posted in September 2020, also establishing an accelerated pathway to Signatera coverage in new testing indications.

Over 200,000 patients per year are treated with immunotherapy.¹ Studies show that only 20-30% of patients respond positively to immunotherapy, yet many patients remain on treatment for much longer than necessary, due to unreliable methods for evaluating disease progression.² In particular, radiographic imaging is unable to differentiate between true disease progression and pseudo-progression. Results from the INSPIRE study, published recently in Nature Cancer, reported that personalized ctDNA monitoring with Signatera can identify treatment non-responders with 100% positive predictive value, just 6 weeks into treatment, when used in conjunction with imaging.

"Monitoring ctDNA kinetics with Signatera can identify treatment non-responders earlier than imaging alone, and independent of other biomarkers including PD-L1 and tumor mutational burden (TMB)," said Solomon Moshkevich, general manager of oncology for Natera. "We look forward to working with Medicare and with the oncology community, to make personalized monitoring and MRD assessment accessible for cancer patients of all tumor types."

The final LCD for immunotherapy monitoring is posted here. This is the second Medicare LCD covering Signatera (the first was in early-stage CRC, found here); but it is the first covering Signatera for pan-cancer use, in any patient where immunotherapy is indicated.

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. This maximizes Signatera's accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Signatera is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions.

About Natera
Natera™ is a leading personalized molecular genetic testing company dedicated to protecting health and transforming what's possible in critical health moments. Our genetic tests help health care providers and their patients better identify health issues, empowering decision making to help enable better health futures. Natera's tests are validated by more than 80 peer-reviewed studies that showcase high accuracy, improving patient care and health outcomes in women's health, oncology, and organ health. 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 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 efforts to develop and commercialize new product offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical or other studies will support the use of our product offerings, 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, or coverage and reimbursement determinations from third-party 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.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., 650-249-9090
Media: Kate Stabrawa, Communications, Natera, Inc., 720-318-4080 pr@natera.com

References

1. IQVIA™ Institute for Human Data Science Releases Global Oncology Trends 2019 Study: Record Number of Cancer Drugs Launched in 2018 across 17 Indications. IQVIA. https://www.iqvia.com/newsroom/2019/05/iqvia-institute-for-human-data-science-releases-global-oncology-trends-2019-study-record-number-of-c. Published 2019.
2. Haslam A, et al. Estimation of the percentage of US patients with cancer who are eligible for and respond to checkpoint inhibitor immunotherapy drugs. JAMA Netw Open. 2019; 2(5):e192535.

 

View original content:https://www.prnewswire.com/news-releases/medicare-publishes-final-local-coverage-determination-for-pan-cancer-immunotherapy-monitoring-with-nateras-signatera-mrd-test-301422393.html

SOURCE Natera, Inc.

FAQ

What is the recent local coverage determination for Natera's Signatera test?

CMS issued a final local coverage determination for Natera's Signatera test, enabling coverage for pan-cancer immunotherapy monitoring for Medicare patients.

How does Signatera improve monitoring for cancer treatment?

Signatera provides personalized monitoring that has demonstrated a 100% predictive value in identifying non-responders to immunotherapy, potentially improving treatment outcomes.

When was the final local coverage determination for Signatera published?

The final local coverage determination for Signatera was announced on November 11, 2021.

What patient population does the Signatera test cover under the new CMS decision?

The coverage applies to Medicare patients being treated with immunotherapy, regardless of tumor type.

How many patients are treated with immunotherapy each year?

Over 200,000 patients are treated with immunotherapy annually.