Bayer and Foundation Medicine Announce Global Collaboration to Develop NGS-Based Companion Diagnostics for Broad-Spectrum Cancer Therapy

Today, Bayer and Foundation Medicine jointly announced a global research and development collaboration to co-develop companion diagnostic tests based on next-generation sequencing (NGS) technology. This agreement enables both parties to develop companion diagnostics for Bayer’s approved and investigational oncology drugs. The first project under this collaboration focuses on developing a companion diagnostic for Vitrakvi (larotrectinib), the well-known “broad-spectrum anticancer drug.” Vitrakvi is currently the only approved TRK inhibitor for the treatment of patients with solid tumors harboring NTRK fusion mutations.

NGS-based companion diagnostic tests are designed to uncover molecular biological information from each patient’s tumor genome, thereby guiding cancer treatment decisions. Foundation Medicine, Inc. is a biotechnology company dedicated to the development of molecular diagnostic tests. Its developed product, FoundationOne CDx, is an NGS-based in vitro diagnostic device capable of detecting substitutions, insertions, deletions, and copy number variations across 324 genes. It also analyzes DNA derived from formalin-fixed paraffin-embedded (FFPE) tumor tissue samples to determine genomic features such as microsatellite instability (MSI) and tumor mutational burden (TMB).

▲Introduction to FoundationOne CDx (Image source: Foundation Medicine official website)

FoundationOne CDx has received FDA approval for detecting genomic alterations in patients with various solid tumors. It is indicated for all solid tumor types and can be used to help select from 17 FDA-approved targeted therapies.

“We are pleased to partner with Foundation Medicine to jointly develop innovative companion diagnostic tests, providing new tools for personalized medicine,” said Mr. Robert LaCaze, Head of Oncology Strategy at Bayer. “The development of a companion diagnostic for Vitrakvi, along with our broad collaboration with Foundation Medicine, represents an important step in expanding testing for cancer patients and helping them identify the right treatment options.”

“Foundation Medicine is pleased to collaborate with Bayer to develop multiple companion diagnostic tests,” said Ms. Cindy Perettie, Chief Executive Officer of Foundation Medicine. “For patients with advanced cancer, undergoing comprehensive genomic analysis at initial diagnosis to help determine their eligibility for specific targeted therapies is critical to their survival.”

References:

[1] Bayer and Foundation Medicine announce global collaboration to develop next-generation sequencing (NGS)-based companion diagnostics in oncology. Retrieved May 29, 2019, from https://www.prnewswire.com/news-releases/bayer-and-foundation-medicine-announce-global-collaboration-to-develop-next-generation-sequencing-ngs-based-companion-diagnostics-in-oncology-300858150.html

[2] Foundation Medicine. Retrieved May 29, 2019, from https://www.foundationmedicine.com/

Original Title: Flash | Bayer Strikes Partnership to Develop NGS Companion Diagnostics for “Broad-Spectrum” Cancer Therapy

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