SAN CARLOS, Calif., Aug. 15, 2018 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, has partnered with Fox Chase Cancer Center, one of the leading cancer centers in the United States, to assess the company's Signatera™ (Research-Use Only) customized circulating tumor DNA (ctDNA) assay for recurrence monitoring of kidney cancer.
The study will analyze biological specimens collected and banked from 49 patients diagnosed with kidney cancer—including a group whose cancer recurred and a group that did not recur after three years or more. The study will use Natera's proprietary customized assay and next-generation sequencing (NGS)-based technology to determine whether Signatera (RUO) can be used to distinguish between the recurring and non-recurring kidney cancer cases. The study will be led by Philip Abbosh, M.D., Ph.D., assistant professor, Molecular Therapeutics Program, Fox Chase Cancer Center.
"There is a paucity of data for circulating tumor DNA in kidney cancer. This research study will explore a novel approach for disease recurrence and treatment response monitoring in kidney cancer, since existing methods have limitations with sensitivity and specificity," Dr. Abbosh said. "Determining the relationship between kidney cancer genetic profiles and prognosis including recurrence using the Signatera assay has great potential to improve patient care by detecting cancer recurrence earlier, assisting adjuvant therapy decision-making, determining treatment effects, and assessing the need for intervention during follow-up."
Kidney cancer is among the 10 most common cancers in both men and women.1 According to the American Cancer Society, more than 60,000 new cases of kidney cancer will be diagnosed this year, and nearly 15,000 people will die from this disease.1
C. Jimmy Lin, M.D., Ph.D., M.H.S., Natera's Chief Scientific Officer, Oncology, said this kidney cancer study joins a growing number of research collaborations the company has established in the past 18 months involving a variety of cancer types, including breast, bladder, colorectal, and lung cancers. "We look forward to working with Fox Chase Cancer Center," Dr. Lin said. "We expect that this study, along with our ongoing research efforts in other cancer types, will help us move toward clinically validating Signatera, with the goal of enabling more precise monitoring, better determination of prognosis, and individualized treatment of disease."
Signatera (RUO) is the first ctDNA assay custom-built for treatment monitoring and minimal residual disease assessment. The Signatera (RUO) methodology differs from currently available liquid biopsy assays, which test for a panel of genes independent of an individual's tumor. In contrast, Signatera (RUO) 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.
A recent study demonstrated the Signatera (RUO) 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).2 Additional research presented at the 2018 American Association for Cancer Research meeting showed successful results from bladder and colorectal cancer studies, including median detection points of ctDNA that were 4.3 and 7.9 months ahead of clinical relapse detection, respectively.3,4
About Fox Chase Cancer Center
The Hospital of Fox Chase Cancer Center and its affiliates (collectively "Fox Chase Cancer Center"), a member of the Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation's first cancer hospitals, Fox Chase was also among the first institutions to be designated a National Cancer Institute Comprehensive Cancer Center in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are also routinely recognized in national rankings, and the Center's nursing program has received the Magnet recognition for excellence four consecutive times. Today, Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research, with special programs in cancer prevention, detection, survivorship and community outreach. For more information, call 1-888-FOX CHASE or (1-888-369-2427).
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.
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.
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- Key Statistics About Kidney Cancer. American Cancer Society Website. https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html. Updated Jan. 4, 2018. Accessed July 26, 2018.
- Abbosh C, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545:446–451. DOI: http://doi.org/10.1038/nature22364
- Birkenkamp-Demtröder K, et al. Sequencing of plasma cfDNA from patients with locally advanced bladder cancer for surveillance and therapeutic efficacy monitoring [abstract]. In: Proceedings of the annual meeting of the American Association for Cancer Research; 2018 April 14-18; Chicago; 2018. Abstract 3653.
- Andersen C, et al. Personalized circulating tumor DNA analysis to monitor colorectal cancer [abstract]. In: Proceedings of the annual meeting of the American Association for Cancer Research; 2018 April 14-18; Chicago; 2018. Abstract 1590.
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