mmPCR can accurately detect CNVs with approximately 5 times higher sensitivity than existing methods
SAN CARLOS, Calif., Oct. 28, 2015 /PRNewswire/ — Natera, Inc., (NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, today announced a study published in the October 2015 issue of Translational Oncology showing that Natera’s massively multiplexed PCR (mmPCR) technology and proprietary analytic methodologies can detect both clonal and subclonal copy-number variants (CNVs) at very low concentrations in a plasma sample (under 1%). By contrast, other sequencing methods that detect CNVs in plasma require circulating tumor DNA concentrations of at least 4% for samples with a single deletion or duplication event in a given region. A CNV is a genetic mutation in which relatively large regions of the genome have been deleted or duplicated. CNVs are thought to play a significant role in many common forms of cancer.
This study successfully identified CNVs in 8 out of 11 plasma samples from patients with stage II breast cancer; no CNVs were detected in plasma of 30 healthy individuals. This is the first published report of a targeted methodology for detection of CNVs in plasma and the first to demonstrate the detection of subclonal CNVs in plasma. This data was generated using a proof-of-concept panel. Natera is currently developing targeted panels for specific cancers covering a broader spectrum of CNVs, point mutations, and gene fusions.
Subclonal mutations (those that only occur in some parts of a tumor) may reduce the efficacy of cancer therapy, because not all regions of a tumor may respond equally. This study demonstrates the ability of Natera’s mmPCR technology to detect subclonal CNVs that may not be detected by a localized biopsy. While the cost and invasiveness of a tissue biopsy can hinder optimal monitoring of a tumor, Natera’s method only requires a simple blood draw.
"Noninvasive liquid biopsies using Natera’s mmPCR-NGS method could be an attractive alternative to both traditional biopsies and existing next generation sequencing-based methods that can detect tumor mutations in plasma samples from patients with late-stage cancer. However, those methods have not been shown to be sufficiently sensitive to detect subclonal mutations," said Matthew Hill, Ph.D., Vice President of Research and Development at Natera and senior author of the paper. "This paper shows Natera’s ability to detect very low fractions of tumor CNVs in plasma with high accuracy, even when tumors are heterogeneous. When combined with our ability to detect SNVs and fusions, we expect we will be able to substantially improve the identification and resulting treatment of many forms of cancer, such as breast, lung, and ovarian cancer."
The study, entitled Detection of clonal and subclonal copy-number variants in cell-free DNA from patients with breast cancer using a massively multiplexed PCR methodology, can be accessed at www.transonc.com.
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 June 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
Michael Hromadik, Media Relations, 858-442-2215
SOURCE Natera, Inc.