On September 24, 2019 Foundation Medicine, Inc. and Natera, Inc. (NASDAQ: NTRA) reported a partnership to develop and commercialize personalized circulating tumor DNA (ctDNA) monitoring assays, for use by biopharmaceutical and clinical customers who order FoundationOneCDx (Press release, Foundation Medicine, SEP 24, 2019, View Source [SID1234539735]). The initial focus of the partnership will be to enable ctDNA monitoring in biopharmaceutical trials in 2020 to establish the clinical utility for these novel assays. Following these studies, a monitoring product will be made available to clinical customers.
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"We are excited to develop monitoring products based on Foundation Medicine’s genomic insights, and we believe that partnering with Natera, a leader in personalized ctDNA monitoring, offers the potential to significantly advance personalized medicine," said Cindy Perettie, Chief Executive Officer of Foundation Medicine. "Cancer monitoring is an important part of patient care and developing innovative and more efficient diagnostics for physicians to identify disease progression and therapy resistance earlier is critical."
The companies will leverage Foundation Medicine’s FoundationOne CDx as the baseline test to define a set of unique variants that will subsequently be monitored utilizing a co-developed assay that includes components of Natera’s Signatera platform. While the initial focus is to develop personalized cancer monitoring assays that are compatible with FoundationOne CDx as the baseline test, Foundation Medicine may also elect to expand the scope of the partnership to develop monitoring assays that utilize genomic data generated from Foundation Medicine’s FoundationOneLiquid test for solid tumors utilizing ctDNA and/or FoundationOneHeme test for hematologic malignancies and sarcomas.
Foundation Medicine has the exclusive right to commercialize the co-developed monitoring assays. Natera will continue to exclusively offer Signatera testing based on whole exome sequencing of tumor and matched normal DNA.
"We are thrilled to partner with Foundation Medicine on this landmark opportunity," said Steve Chapman, Natera’s Chief Executive Officer. "This partnership accelerates Natera’s progress towards making personalized ctDNA monitoring the global standard of care for evaluating patient response to cancer therapy."
Foundation Medicine’s tests are ordered by physicians for more than 100,000 patients per year, and the company has more than 50 active biopharma partnerships.