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Agreements

Date: 2018-01-16

Type of information: Collaboration agreement

Compound: companion diagnostics (CDx) that will be included in updates to FoundationOne CDx™. FoundationOne CDx is Foundation Medicine's FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that incorporates multiple companion diagnostics.

Company: Foundation Medicine (USA - MA) Pfizer (USA - NY)

Therapeutic area: Cancer - Oncology

Type agreement:

Action mechanism:

  • companion diagnostic. FoundationOne CDx assesses all classes of genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It also reports genomic biomarkers, such as microsatellite instability (MSI) and tumor mutational burden (TMB), that can help inform the use of immunotherapies; genomic alterations in other genes relevant to patient management; and relevant clinical trial information. As such, it is designed to help streamline companion diagnostic development, mitigate risk and advance targeted therapy development. Currently FoundationOne CDx is FDA-approved as a CGP assay for all solid tumors and a broad companion diagnostic for patients with certain types of non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies.

Disease:

Details:

  • • On January 16, 2018, Foundation Medicine and Pfizer have entered into a broad partnership focused on development, regulatory support and commercialization of companion diagnostics (CDx) that will be included in updates to FoundationOne CDx™. FoundationOne CDx is Foundation Medicine's FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that incorporates multiple companion diagnostics.
  • Pfizer will also benefit from access to FoundationInsights™, Foundation Medicine's data analytics platform, to facilitate novel biomarker discovery and to optimize clinical trial design. The unique combination of FoundationInsights™ and FoundationOne CDx will potentially enable Pfizer to leverage Foundation Medicine's platform technology to accelerate discovery and development of precision oncology therapeutics.
 

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