AUSTIN, Texas, April 24, 2025 — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that its ultra-sensitive Signatera Genome assay is now broadly available to physicians in the United States.
This launch is supported by a large genome-based molecular residual disease (MRD) study, which was accepted and will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. In this clinical validation study of more than 3,000 samples from multiple cancer types – including breast cancer, colorectal cancer, non-small cell lung cancer, melanoma, and renal cell carcinoma – Signatera Genome was able to detect circulating tumor DNA (ctDNA) significantly ahead of clinical recurrence with excellent performance. In addition, postsurgical Signatera-positive patients had inferior recurrence-free survival compared to Signatera-negative patients, consistently across the different cancers that were evaluated. Additional clinical utility data on the Signatera Genome assay, including predictive data, will be presented at the conference.
Signatera Genome is available in CLIA, IUO and RUO and was designed to improve patient management as an ultra-sensitive assay for the detection of ctDNA. The test’s bespoke assay is designed from a whole genome sequence of a patient’s tumor and matched normal DNA. It benefits from Natera’s patented multiplex polymerase chain reaction and next generation sequencing technology (mPCR-NGS), using a targeted and deep sequencing approach to detect tiny traces of tumor DNA at frequencies as low as 1 part per million (PPM). An RUO version of the assay is available that detects below 1 PPM.
“We are extremely pleased with the emerging evidence for our Signatera Genome assay, providing an ultrasensitive MRD detection tool for physicians,” said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer. “We look forward to sharing the results of this study, which further demonstrates the clinical utility of Signatera across disease indications.”