Performance Data for Treatment Monitoring, Recurrence Monitoring, and Staging at Diagnosis
SAN CARLOS, Calif., April 13, 2018 /PRNewswire/ — Natera (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, will present data demonstrating the ability of Signatera™ (Research Use Only) to monitor treatment response, detect minimal residual disease, and identify disease recurrence in bladder and colorectal cancers at the AACR (American Association for Cancer Research) Annual Meeting in Chicago, April 14-18, 2018.
"Having replicated our outstanding performance across lung cancer, bladder cancer, and colon cancer, we believe that Signatera is showing promise as a pan-cancer platform," said Jimmy Lin, M.D., Ph.D., MHS, Natera’s Chief Scientific Officer, Oncology. "We look forward to Signatera’s use in clinical trials, for patient selection and treatment response evaluation in the adjuvant, neoadjuvant and metastatic settings."
Three posters will be presented at the AACR Annual Meeting:
- April 16, 2018, 8:00 a.m.–12:00 p.m., Section 26: Personalized circulating tumor DNA analysis to monitor colorectal cancer (Poster board 17, Abstract 1590, Exhibit Hall A, Section 26)
- April 17, 2018, 8:00 a.m.–12:00 p.m., Section 27: Sequencing of plasma of cfDNA from patients with locally advanced bladder cancer for surveillance and therapeutic efficacy monitoring (Poster board 11, Abstract 3653, Exhibit Hall A, Section 27)
- April 17, 2018, 1:00–5:00 p.m., Section 24: Analytical validation of the Signatera RUO assay, a highly sensitive patient-specific multiplex PCR NGS-based noninvasive cancer recurrence detection and therapy monitoring assay (Poster board 27, Abstract 4542, Exhibit Hall A, Section 24)
Natera also will host an Exhibitor Spotlight Theatre on Sunday, April 15 at 1:30 p.m., titled, "Clonal ctDNA Monitoring Using Signatera (RUO) Platform: Pan-Cancer Applications for Biopharmaceutical Research."
Signatera (RUO) was recently launched for use by oncology researchers and biopharmaceutical companies, and is expected to be available for clinical use next year. The technology differs from currently-available liquid biopsy assays, which test for a panel of genes independent of an individual’s tumor. It provides each patient with a customized blood test tailored to match the mutations found in that individual’s tumor tissue, which maximizes sensitivity and specificity. Signatera (RUO) also allows researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies.
In a recent study featured on the cover of the journal Nature, the Signatera (RUO) customized ctDNA platform demonstrated the method’s ability to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care for early stage non-small cell lung cancer (NSCLC).1
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic diseases. 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. Follow Natera on LinkedIn and Twitter.
Forward Looking Statements
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 offerings, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers. 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.
- Abbosh C. et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature 545, 446–451 (2017)