The companion diagnostics will be used to identifying patients eligible for patients taking Takeda’s drugs brigatinib and mobocertinibto for mNSCLC


FoundationOne Liquid CDx is a prescription-only next-generation sequencing (NGS)-based in vitro diagnostic test. (Credit: Belova59 from Pixabay.)

Foundation Medicine has collaborated with Takeda Pharmaceuticals USA, to develop its companion diagnostics (CDx) for use with the latter’s portfolio of advanced lung cancer therapies.

Takeda Pharmaceuticals USA is a fully owned subsidiary of Japan-based Takeda Pharmaceutical Company. Foundation Medicine is a molecular diagnostic company of Roche, offering complete genomic profiling assays to identify molecular alterations in a patient’s cancer.

Once approved, the potential companion diagnostics FoundationOneCDx and FoundationOneLiquid CDx are expected to be used for identifying patients who may be eligible for Takeda’s drugs brigatinib and mobocertinib, to treat metastatic non-small cell lung cancer (mNSCLC).

Foundation Medicine chief executive officer Cindy Perettie said: “We’re proud to partner with Takeda on this important journey to allow more lung cancer patients to have access to genomic testing to inform personalized treatment decisions.

“Takeda shares our patient-centric approach to research and development and mission to advance personalized cancer care. This collaboration leveraging our portfolio of FDA-approved genomic tests will accelerate our shared vision and make precision medicine a reality for more patients.”

The collaboration will develop FoundationOne CDx and FoundationOne Liquid CDx

Under the collaboration, Foundation Medicine’s companion diagnostics FoundationOne CDx and FoundationOne Liquid CDx will be developed for use with Takeda’s lung cancer therapies.

FoundationOne Liquid CDx is a prescription-only next-generation sequencing (NGS)-based in vitro diagnostic test that leverages hybridisation-based capture technology.

The CDx analyses 324 genes using circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients.

FoundationOne CDx is also an NGS-based in vitro diagnostic device indicated for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, along with genomic signatures.

The genomic signatures include microsatellite instability (MSI) and tumour mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens.

FoundationOne CDx is intended to identify patients who may benefit from treatment with certain targeted therapies, and to provide tumour mutation profiling for patients with solid malignant neoplasms.

Takeda oncology therapeutic area unit head Christopher Arendt said: “Our collaboration with Foundation Medicine will address an urgent need for broad access to genomic tests, ultimately expanding treatment options and potentially improving outcomes for people with ALK+ and EGFR Exon20 insertion+ mNSCLC.

“Robust, accurate and timely testing is crucial to enable oncologists to make informed treatment decisions so that advanced cancer patients receive the optimal therapy for their disease.”