NEW YORK – Roche subsidiary Foundation Medicine and German pharmaceutical company Merck KGaA announced on Monday that they have entered a strategic collaboration to develop companion diagnostics for the US market.
The companies will develop the FoundationOne CDx and FoundationOne Liquid CDx tests as companion diagnostics for selected marketed and pipeline treatments from Merck KGaA. The new agreement builds on a previous data solutions partnership the firms entered in 2020 to accelerate the development of novel targeted therapies individually and in combination, the companies said in a statement.
If the companion diagnostic indications are approved, oncologists will be able to use the Foundation tests to identify patients with genomic alterations that could make them eligible for a specific targeted therapy. FoundationOne CDx detects substitutions, insertions, deletions, and copy number alterations in 324 genes, as well as select gene rearrangements, using DNA from formalin-fixed, paraffin-embedded tumor tissue specimens. It also detects genomic signatures such as microsatellite instability and tumor mutational burden.
FoundationOne Liquid CDx analyzes 324 genes via circulating cell-free DNA isolated from plasma in advanced cancer patients. Both next-generation sequencing-based assays are approved by the US Food and Drug Administration.
"We look forward to ongoing collaboration as they leverage our portfolio of end-to-end solutions to generate meaningful evidence, help optimize therapy development, and deliver companion diagnostic solutions using our tissue and liquid comprehensive genomic profiling tests," Jason Adams, VP of biopharma enterprise partnerships at Foundation Medicine, said in a statement.