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Foundation Medicine, Natera to Develop Liquid Biopsy Monitoring Assays

This article has been updated with financial and other details from a Natera regulatory filing.

NEW YORK – Foundation Medicine and Natera said today that they will jointly develop and commercialize personalized circulating tumor DNA monitoring assays for biopharmaceutical and clinical customers who order the FoundationOne CDx test.

Under the agreement, Foundation Medicine will pay Natera approximately $13 million in upfront licensing fees and prepaid revenues, according to a filing with the US Securities and Exchange Commission by Natera. It will also pay Natera up to approximately $32 million in minimum annual payments and payments tied to Natera's achievement of certain developmental, regulatory, and commercial milestones. In addition, Foundation Medicine, at its discretion, may pay Natera option fees and contract extension fees. Both companies will share in the revenues generated from biopharmaceutical and clinical customers.

The companies plan to use Foundation Medicine's FoundationOne CDx test as the baseline to define a set of unique variants that the codeveloped liquid biopsy assays, which will include components of Natera's Signatera platform, will monitor.

Foundation Medicine has the option to expand the partnership to also include its FoundationOne Liquid or FoundationOne Heme tests as the baseline for the monitoring assays.

Under the partnership, Foundation Medicine, a unit of Roche, has the exclusive right to commercialize the codeveloped monitoring assays. Natera will continue to exclusively offer its Signatera test, which is based on whole-exome sequencing of tumor and matched normal DNA.

The initial focus of the partnership will be on ctDNA monitoring in biopharmaceutical trials in 2020 to establish the clinical utility of the assays. After the studies are completed, the companies plan to make monitoring assays available to clinical customers.

"This partnership accelerates Natera's progress towards making personalized ctDNA monitoring the global standard of care for evaluating patient response to cancer therapy," said Natera CEO Steve Chapman.