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Foundation Medicine, Pierre Fabre Laboratories to Collaborate on CDx for Lung Cancer

NEW YORK – Roche subsidiary Foundation Medicine announced on Wednesday that it will collaborate with Pierre Fabre Laboratories to develop Foundation's genomic tests as companion diagnostics for therapies for patients with non-small cell lung cancer (NSCLC). 

The companies will seek regulatory approval in the EU for FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for Pierre Fabre Laboratories' BRAF-MEK inhibitor combination regimen Braftovi (encorafenib) and Mektovi (binimetinib). The combination therapy is under evaluation by the European Medicines Agency for patients with BRAF V600-mutant advanced NSCLC, the companies said in a statement. It was evaluated in a clinical trial sponsored by Pfizer, which has rights to Braftovi and Mektovi in the US, and supported by Pierre Fabre. 

"Today, as the number of indications and approvals in oncology grow rapidly, companion diagnostics provide information that is critical for the safe and effective use of targeted therapies. And that's why we are excited to work with Foundation Medicine," Núria Perez-Cullell, head of Pierre Fabre's medical and patient consumer department, said in a statement. "Thanks to those companion diagnostics, physicians will have comprehensive, reliable information about what is driving a patient's cancer, such as BRAF V600E mutations, so they can make personalized treatment decisions."

Both FoundationOne CDx and FoundationOne Liquid CDx are next-generation sequencing-based tests that analyze more than 300 genes within formalin-fixed, paraffin-embedded tumor tissue specimens and cell-free DNA isolated from plasma, respectively. Last month, both tests were approved by the US Food and Drug Administration as companion diagnostics for the Braftovi-Mektovi combination in metastatic NSCLC patients.