Pfizer puts Foundation Medicine at the center of its cancer companion diagnostic strategy

FoundationOne CDx (Foundation Medicine)

Pfizer has struck a broad cancer companion diagnostic deal with Foundation Medicine. The alliance will see Foundation Medicine use pan-cancer test FoundationOne CDx as a companion diagnostic for Pfizer drugs.

Foundation Medicine won approval for the NGS-based test late last year. The approval marked a step forward for the company’s companion diagnostic strategy. With the core test already approved by the FDA, Foundation Medicine can expand its use to cover other drugs through supplemental PMA filings. That is an easier, less risky route to market than that traditionally followed by companion diagnostics. 

Pfizer has been quick to strike a deal that taps into the potential of the new approach. The pharma giant is teaming up with Foundation Medicine to work on updates to FoundationOne CDx that will meet its need for companion diagnostics to support its pipeline of oncology candidates. 


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Given that Pfizer has 17 cancer drugs in clinical development, the deal could be significant for Foundation Medicine’s companion diagnostic strategy. 

“The combination of our FDA-approved comprehensive genomic profiling platform and molecular information solutions, coupled with Pfizer’s robust oncology portfolio, enables us to enhance the impact of precision oncology to advance patient care,” Melanie Nallicheri, head of biopharma at Foundation Medicine, said in a statement.

RELATED: Foundation Medicine gets FDA, CMS nods for pan-cancer genomic test

Pfizer is also gaining access to Foundation Medicine technologies that could help it to discover biomarkers and improve the efficiency of its clinical trials. 

News of the Pfizer deal precedes another anticipated milestone for FoundationOne CDx. Foundation Medicine secured FDA clearance at the same time as it received a draft coverage nod for Medicare. The Medicare coverage policy is due to be finalized by the end of the first quarter. 

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