New Study Validates the Signatera® MRD Test and Demonstrates its Clinical Utility in Early-Stage Esophageal Cancer

Rhea-AI Summary

Natera (NASDAQ: NTRA) announced a new peer-reviewed study validating its Signatera molecular residual disease (MRD) assay for esophageal adenocarcinoma (EAC). The study involved 20 EAC patients and showed that Signatera had a sensitivity of 80% in detecting recurrence, with a median lead time of almost one year before clinical detection. MRD-positive patients had a disease-free survival of 14.2 months versus 51.2 months for MRD-negative patients. This research highlights the potential for Signatera to improve treatment decisions in the growing incidence of esophageal cancer.

Positive

• Signatera demonstrated 80% sensitivity in detecting recurrence in EAC patients.
• The assay allowed for a median lead time of almost one year before clinical recurrence detection.
• MRD-positive patients had significantly shorter disease-free survival (14.2 months) compared to MRD-negative patients (51.2 months).

Negative

• None.

AUSTIN, Texas, July 28, 2021 /PRNewswire/ -- Natera,Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, today announced a new peer-reviewed paper published in Gastroenterology validating its personalized and tumor-informed molecular residual disease (MRD) assay, Signatera, in resected esophageal adenocarcinoma (EAC). The paper can be found here.

The study represents the first published data on the use of Signatera in EAC and demonstrates the potential of the Signatera technology in esophageal cancer, which sees around 20,000 new cases per year in the U.S.¹

Key findings from this retrospective study of 20 EAC patients after resection:

• Signatera detected recurrence with a sensitivity of 80% (4/5). The only missed recurrence had the last sample drawn two years before recurrence. The specificity was 100% (12/12) and the PPV was 100%.
• Signatera detected recurrence with a median lead time of almost one year before clinical or radiological recurrence.
• Postsurgical MRD-positive patients had disease-free survival of 14.2 months, compared to 51.2 months in MRD-negative patients, indicating prognostic value in this setting.
• Patients who were MRD-positive preoperatively and became MRD-negative after surgery had a good prognosis, indicating that Signatera can potentially be used to risk-stratify patients for adjuvant therapy.

"The incidence of esophageal cancer is on the rise globally and more than half of these patients experience recurrence after surgery or treatment with curative intent,"^2,3 said Alexey Aleshin, M.D., M.B.A., vice president of medical affairs, oncology at Natera. "For these patients, a sensitive prognostic biomarker, such as Signatera status, could have significant clinical utility in predicting relapse and guiding adjuvant treatment decisions."

This study comes on the heels of another peer-reviewed study recently published in JCO Precision Oncology validating Signatera in oligometastatic cancer, adding to the growing body of evidence behind Signatera in gastrointestinal cancers. To date, Signatera has been published in 14 peer-reviewed publications, in a wide range of cancer types, including colorectal, breast, lung, bladder, pancreatic and more.

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.

Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

About Natera

Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on 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. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

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 be repeated in later studies or 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. 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. Key Statistics for Esophageal Cancer. American Cancer Society. https://www.cancer.org/cancer/esophagus-cancer/about/key-statistics.html
2. Edgren G, Adami HO, Weiderpass E, Nyrén O. A global assessment of the oesophageal adenocarcinoma epidemic. Gut. 2013;62(10):1406-14.  
3. Al-Batran SE, et al. Perioperative chemotherapy with fluorouracil plus leucovorin, oxaliplatin, and docetaxel versus fluorouracil or capecitabine plus cisplatin and epirubicin for locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4): a randomised, phase 2/3 trial. Lancet. 2019;393(10184):1948-1957.

 

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SOURCE Natera, Inc.

FAQ

What is the significance of the new study on Signatera by Natera?

The study validates the clinical utility of Signatera in detecting recurrence of esophageal adenocarcinoma, showcasing its potential impact on patient treatment.

What were the key findings of the Signatera study for EAC?

The study found that Signatera had 80% sensitivity for detecting recurrence and allowed for early detection almost one year prior to clinical symptoms.

How does Signatera affect disease-free survival in EAC patients?

Patients who tested MRD-negative using Signatera had an average disease-free survival of 51.2 months, while MRD-positive patients had only 14.2 months.

What is the market potential for Signatera in treating esophageal cancer?

With around 20,000 new EAC cases annually in the U.S., Signatera positions Natera to address a significant clinical need as esophageal cancer incidence rises.

When was the study validating Signatera published?

The study was published on July 28, 2021.