Foundation Medicine said Monday that it has entered a strategic collaboration with Merck KGaA in Darmstadt, Germany to develop FoundationOne Liquid CDx and FoundationOne CDx as companion diagnostics in the U.S. market for selected marketed and pipeline treatments.
The agreement builds on a partnership that the firms entered in 2020 to accelerate the development of novel targeted therapies, individually and in combination.
FoundationOne CDx is a next-generation sequencing (NGS) test for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations in 324 genes and select gene rearrangements. It also detects genomic signatures including microsatellite instability and tumor mutational burden using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne Liquid CDx is a qualitative NGS diagnostic test for prescription use only that uses targeted high-throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients.
If the companion diagnostic indications are approved, oncologists will be able to use FoundationOne CDx or FoundationOne Liquid CDx to identify those with genomic alterations that may make them eligible for a specific targeted therapy. Use of the test will depend on tissue availability and the presentation of individual patients, said Foundation Medicine, which is a subsidiary of Roche.
