Foundation Medicine Inc. and Natera Inc. will collaborate to develop and commercialize personalized circulating tumor DNA monitoring assays, which biopharmaceutical and clinical customers who order FoundationOne CDx would be able to access.
The partnership’s focus 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.
“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,” Foundation Medicine CEO Cindy Perettie said in a statement.
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 using a co-developed assay that includes components of Natera’s Signatera platform.
The initial focus is to develop personalized cancer monitoring assays that are compatible with FoundationOne CDx as the baseline test, but 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 FoundationOne Liquid test for solid tumors utilizing ctDNA and/or FoundationOne Heme 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.
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, the company said.