Analysis of liquid biopsies can detect mutations that may be missed in tumor tissue biopsies
SAN CARLOS, Calif., March 7, 2016 /PRNewswire/ — Natera, Inc., (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, today announced a study published in Annals of Oncology showing that Natera's massively multiplexed PCR (mmPCR) technology, coupled with its proprietary algorithms, can detect both ubiquitous (clonal) and heterogeneous (subclonal) tumor mutation variants in blood samples from patients with early-stage non‒small-cell lung cancer (NSCLC).
Of 37 variants found in tumor tissue biopsies from four patients with Stage I and II lung cancer, 16 variants were detected in the blood samples, with at least two detected for each patient. Twenty-five percent of the variants detected in the blood samples were heterogeneous, meaning that they occurred in only part of a tumor. Ninety-four percent of the variants detected in the blood samples were predicted driver mutations, meaning that they were likely to promote tumor growth.
"In this pilot study, Natera's technology helped us demonstrate that both clonal and subclonal tumor mutations are present in the cell-free DNA of patients with early-stage lung cancer," said Charles Swanton, M.D., Ph.D., of the Translational Cancer Therapeutics Laboratory at The Francis Crick Institute in London, and senior author of the paper. "We look forward to expanding our collaboration with Natera as part of the TRACERx study." TRACERx (ClinicalTrials.gov NCT01888601), funded by Cancer Research UK, is a national collaboration between six clinical centers and four centers of scientific expertise in the U.K., and is intended to study tumor heterogeneity in lung cancer patients over time. Natera's technology was selected to provide analysis of cell-free DNA in plasma for the trial.
Natera's non-invasive testing method can assess the overall mutation load in patients with cancer using only a blood sample. This methodology may detect variants in plasma cell-free DNA that, due to the heterogeneous nature of tumors, may not be detected by tissue biopsy. Since subclonal variants are expected to be present at substantially lower tumor fraction in plasma than clonal variants, the ability to detect variants at low concentrations is important in the detection of emerging variants that could affect treatment.
Natera's mmPCR technology and proprietary algorithms were developed in the context of non-invasive prenatal testing (NIPT), which can identify Down syndrome and other chromosomal aneuploidies and microdeletions with high accuracy. Natera has enhanced this underlying technology for the oncology applications, and believes that it has powerful tools for the early identification of cancer and for therapeutic monitoring.
The study, entitled "Detection of Ubiquitous and Heterogeneous Mutations in Cell-Free DNA from Patients with Early-Stage Non‒Small-Cell Lung Cancer," can be accessed at annonc.oxfordjournals.org.
Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software system. Tests include the Spectrum® pre-implantation genetic test for embryo selection during IVF; the Anora® miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier screen to detect inherited mutations; and the Panorama® non-invasive prenatal test (NIPT) to screen for common chromosomal anomalies in a fetus as early as nine weeks of gestation. Natera 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 been cleared or approved by the U.S. Food and Drug Administration.
This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding Natera's plans to develop and launch commercially available diagnostics and monitoring technology for cancer, are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera's historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release. These forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results to differ materially, including uncertainty in the development and commercialization of Natera's planned future cancer products or other new products or if the results of its clinical studies do not support the use of its tests, or cannot be replicated in later studies required for regulatory approvals or clearances. Additional risks and uncertainties are discussed in greater detail in the sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Natera's Form 10-Q for the quarter ended September 30, 2015. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. These documents are available for free on the company's website at www.natera.com under the Investor Relations section, and on the SEC's website at www.sec.gov.
Mike Brophy, Investor Relations, 650-249-9091 x 1471