Natera, Inc. (NASDAQ: NTRA) Natera, a leader in cell-free DNA testing, today announced plans to commercialize a research-use-only (RUO) service for whole exome sequencing (WES) of circulating tumor DNA, using plasma samples from patients with cancer. The new service is expected to be available in the second half of 2019.
The assay does not require tumor tissue and will interrogate approximately 20,000 genes from circulating tumor DNA (ctDNA) to detect somatic mutations, representing a significant increase in coverage over most commercially available fixed liquid biopsy panels. There are multiple benefits to the new plasma exome sequencing offering, including the ability to design Signatera™ assays when tissue is not available. The assay may also allow researchers to characterize resistance mutations, actionable mutations, neoantigens, and tumor evolution. Finally, this capability will enhance Natera’s oncology database by generating valuable new data about tumor evolution over time.
The plasma exome service can be ordered as a stand-alone assay, or reflexively for Signatera ctDNA-positive cases. Many researchers want a comprehensive view of tumor evolution in order to link to treatments and outcomes, but it is very expensive to conduct a comprehensive analysis in early-stage or adjuvant disease, where tumor DNA is often not detectable in the plasma. With the combined service, researchers can first use Signatera to monitor patients for the presence or absence of ctDNA, and for positive patients they can reflex to a plasma exome to characterize tumor evolution using the same exact DNA library sample.
The first of multiple publications has been accepted in a top peer-reviewed journal and is expected to be published this quarter. Initial data has shown concordance between WES from tissue and plasma, and also strong concordance between WES and Signatera (RUO). “This exciting capability grows out of our deep molecular and bioinformatics expertise, and optimized sample and library preparation methods which consistently deliver a high yield of cell-free DNA molecules,” said Bernhard Zimmermann, Natera Vice President, Research and Development. “This expertise will enable multiple new research applications in oncology.”
“The plasma exome capability adds an important component to our suite of services for cancer researchers,” said Eric Lindquist, Natera Vice President, Oncology Business Development. “We are pleased with the significant momentum in our pharma business and believe we are on track to achieve our goal of $40 to $50 million in cumulative contracted value. Our combined offerings enable us to access the approximately $21 billion ctDNA molecular residual disease and liquid biopsy market in a very competitive manner.”
Signatera is the first circulating tumor DNA (ctDNA) test custom-built for molecular treatment monitoring and molecular residual disease (MRD) assessment. The test is available for research use only (RUO) until its clinical launch planned for Q2 2019. The Signatera methodology differs from currently available liquid biopsy tests, which test for a fixed panel of therapeutically relevant genes. Signatera provides each individual with a customized blood test tailored to match the clonal mutations found in that individual’s tumor tissue. This maximizes accuracy for detecting the presence or absence of MRD in a blood sample, even at levels down to a single mutant molecule in a tube of blood. Signatera also allows researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies.
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn and Twitter.
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product and service offerings, our ability to successfully increase demand for and grow revenues for our product and service offerings, our collaborations with commercial partners such as medical institutions, contract laboratories, laboratory partners, and other third parties, whether the results of clinical studies will support the use of our product and service offerings, our expectations of the reliability, accuracy and performance of our screening tests, of the benefits of our screening tests and product and service offerings to patients, providers, payers, researchers and pharmaceutical companies, or of the size of the markets into which we are offering our products and services. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.
This test was developed by Natera, Inc. a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.
Media Contact Information
Sullivan & Sampson