Foundation Medicine Inc. said the company has entered into a broad partnership with Pfizer Inc.
The partnership focuses on development, regulatory support and commercialization of companion diagnostics that will be included in updates to FoundationOne CDx.
FoundationOne CDx is Foundation Medicine’s FDA-approved comprehensive genomic profiling 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.
Pfizer currently has 10 FDA-approved oncology medicines that treat a diverse array of solid tumors and hematologic malignancies. In addition, its oncology pipeline includes 17 assets in clinical development and 19 phase III studies.
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 and tumor mutational burden, 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.
Concurrent with FDA approval, the Centers for Medicare & Medicaid Services issued a preliminary National Coverage Determination for FoundationOne CDx. The draft NCD would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage with evidence development in other solid tumor types. The final policy is expected to issue during the first quarter of 2018 following public comment on the preliminary NCD and an administrative period.
FoundationOne CDx is a sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens.
FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling.
Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms.
