Benzinga | Jul 28, 2021 09:04AM EDT

Natera Reports New Study Validates Signatera Molecular Residual Disease Test

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.