Natera, Inc. Announces New Publication Validating Signatera® Velocity Metric to Improve Cancer Management
October 11, 2021 at 08:33 am EDT
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Natera, Inc. announced the publication of a new study in Clinical Cancer Research demonstrating the ability of its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to assess tumor growth rates and predict patient survival in early-stage colorectal cancer (CRC). In previous studies, Signatera was validated to detect early-stage CRC recurrence 8.7 months earlier than CT imaging (median lead time), simply based on positive or negative MRD status. Without treatment, more than 98% of MRD-positive patients go on to relapse. This new study replicates that previous test performance in a larger, multi-center cohort; but it also demonstrates that MRD-positive patients can be further stratified based on the quantity of circulating tumor DNA (ctDNA) found in the blood, in particular, how quickly those levels grow over time (ctDNA growth rate, or ctDNA velocity). Every Signatera test report contains positive/negative MRD status as well as the mean number of tumor molecules observed per mL of plasma (MTM/mL). With serial testing, these quantities can be compared over time to calculate ctDNA velocity, a unique metric that Natera will make available to its customers. The publication describes a prospectively-collected, multicenter study of 168 stage III CRC patients undergoing curative intent treatment, with longitudinal MRD assessment before and after surgery, and then at regular intervals throughout adjuvant chemotherapy (ACT) and surveillance for up to 3 years (n=1204 samples). Key findings from the study include: Patients who remain MRD-positive after completion of ACT were highly likely to recur (HR 50.80), with a median lead time of 9.8 months ahead of radiographic recurrence, MRD-positive patients with slow-growing tumors (average 27% ctDNA-increase per month) experienced OS similar to those who did not relapse at all (3-year OS 100%); while patients with fast-growing tumors (average 137% increase per month) experienced poor outcomes with 3-year OS 37.5%, Persistent ctDNA clearance during and after ACT was strongly associated with good outcomes (100% 3-year RFS), while transient ctDNA clearance during ACT was associated with poor prognosis (0% 3-year RFS).
Natera, Inc. is a diagnostics company, which is focused on the development and commercialization of molecular testing services, applying its technology in the fields of womenâs health, oncology and organ health. Its cell-free deoxyribonucleic acid (cfDNA) technology combines its molecular assays, which reliably measure many informative regions across the genome from samples as small as a single cell. The Company's product offerings include Panorama Non-Invasive Prenatal Test (NIPT), Vistara, Horizon Carrier Screening, Spectrum Preimplantation Genetics, Anora Miscarriage Test, Empower, and Prospera. The Company also offers Constellation, a cloud-based software platform that enables laboratory customers to gain access through the cloud to the Companyâs algorithms and bioinformatics in order to validate and launch tests based on the Companyâs technology. Its NIPT screens for chromosomal abnormalities of a fetus as well as in twin pregnancies, typically with a blood draw from the mother.
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