22 August 2017 - - San Carlos, California-based genetic testing services company Natera, Inc. (NASDAQ: NTRA) has launched Signatera, a circulating tumor DNA (ctDNA) technology that analyzes and tracks mutations specific to an individual's tumor, for research use only by oncology researchers and biopharmaceutical companies, the company said.
Already in clinical validation with multiple world-leading cancer institutes, Signatera offers a novel personalized approach to cancer detection in plasma.
The technology analyses whole-exome sequencing data from a patient's tumor sample in order to custom design individual-specific assays, targeting 16 or more tumor signatures, mutations known to be present in the tumor tissue, enabling high sensitivity and specificity for ctDNA detection and monitoring.
By targeting 16 or more patient-specific mutations, Signatera has a higher probability of detecting ctDNA targets in plasma, compared with a generic-panel approach.
It detects variant allele frequencies down to 0.01%, and is optimised to achieve high specificity by requiring detection of multiple mutations for a ctDNA-positive call, leading to fewer false positives.
An early version of Signatera identified 43% more ctDNA-positive early-stage lung cancer cases than a generic lung cancer panel and demonstrated its potential to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care.
Natera is a genetic testing company that develops and commercializes non-invasive methods for analysing DNA.
It operates a CAP-accredited laboratory and offers proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation software platform.
The company is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not yet been cleared or approved by the FDA.