Natera, Inc, a leader in non-invasive genetic testing, today announced the launch of SignateraTM, a circulating tumor DNA (ctDNA) technology that analyzes and tracks mutations specific to an individual’s tumor, for research use only (RUO) by oncology researchers and biopharmaceutical companies.
Already in clinical validation with multiple world-leading cancer institutes, SignateraTM offers a novel personalized approach to cancer detection in plasma. The technology analyzes whole-exome sequencing data from a patient’s tumor sample in order to custom design individual-specific assays, targeting 16 or more mutations known to be present in the tumor tissue (“tumor signatures”). This unique approach enables high sensitivity and specificity for ctDNA detection and monitoring.
“We are excited to make this breakthrough technology available for researchers in academia and the pharmaceutical industry,” said Matthew Rabinowitz, Ph.D., Natera’s chief executive officer. “We also look forward to this personalized, non-invasive approach potentially being used to save lives in the clinic by enabling earlier diagnosis, more precise monitoring, better determination of prognosis, and individualized treatment of disease.”
SignateraTM differs from currently available liquid biopsy tests, which screen for a generic set of mutations independent of an individual’s tumor. By targeting 16 or more patient-specific mutations, SignateraTM has a higher probability of detecting ctDNA targets in plasma, compared with a generic-panel approach. It detects variant allele frequencies (VAF) down to 0.01%—one mutant copy in a background of 10,000 genomic copies—and is optimized to achieve high specificity by requiring detection of multiple mutations for a ctDNA-positive call, leading to fewer false positives.1Furthermore, SignateraTM provides researchers the flexibility to track additional mutations of interest, up to several hundred mutations, for clinical studies.
A recent study featured on the cover of the journal Nature demonstrated the value of Natera’s personalized ctDNA analysis for use in cancer research. The study showed that an early version of SignateraTM 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.1
Phylogenetic ctDNA tracking
Overview of the study methodology. Multi-region sequencing of NSCLC was performed as part of the TRACERx study. PCR assay panels were designed on the basis of the phylogenetic analysis, targeting clonal and subclonal SNVs to facilitate non-invasive tracking of the patient-specific tumour phylogeny. Assay panels were combined into multiplex assay pools containing primers from up to 10 patients. Cell-free DNA (cfDNA) was extracted from pre- and postoperative plasma samples and multiplex-PCR was performed, followed by sequencing of the amplicons. Findings were integrated with M-seq exome data to track tumour evolution.
“Natera’s novel and unique technology indicates that it can be well-suited for adaptive clinical studies focused on a wide variety of tumor types,” said Laura van ‘t Veer, Ph.D., leader of the University of California San Francisco (UCSF) Breast Oncology Program and chair of the I-SPY 2 biomolecular committee. “Selecting Natera’s personalized ctDNA technology as part of the I-SPY 2 TRIAL will improve our ability to determine the success of new agents or combinations, help us design additional targeted interventions, and accelerate the pace of making effective, targeted treatments available to the women who will benefit most.
Source – PR Newswire