Therapy Areas: Devices
Natera Inc passes US FDA breakthrough device designation for use of the Signatera Test in pharmaceutical trials
7 May 2019 -

DNA testing company Natera Inc (NASDAQ:NTRA) reported on Monday the receipt of the US Food and Drug Administration (FDA) breakthrough device designation for the Signatera test for the post-surgical detection and quantification of circulating tumor DNA in the blood of patients previously diagnosed with certain types of cancer.

US FDA breakthrough device designation will help accelerate the assessment and review of the company's Signatera as an in vitro diagnostic for use in pharmaceutical trials as well as improve upon current clinical standards.

According to the company, Signatera is the first circulating tumour DNA (ctDNA) test custom-built for molecular treatment monitoring and molecular residual disease (MRD) assessment. It provides each individual with a customised blood test tailored to match the clonal mutations found in that individual's tumour tissue. This maximizes accuracy for detecting the presence or absence of MRD in a blood sample, even at levels down to a single mutant molecule in a tube of blood.

In numerous clinical studies, across non-small cell lung, bladder, breast and colorectal cancers, Signatera has identified the molecular residual disease significantly earlier (up to two years earlier) than standard imaging.

Additionally, Signatera test status is the most significant predictor of long-term patient outcomes after surgery and treatment, relative to all other clinical and pathological factors, concluded the company.