Pfizer, Foundation Medicine Strike Cancer Companion Diagnostic Deal
Foundation Medicine has now announced its broad companion development diagnostics deal with Pfizer’s for the latter’s oncology portfolio.
The new companion diagnostics will be included in updates to FoundationOne CDx, Foundation Medicine’s comprehensive genomic profiling assay for solid tumors that includes multiple companion diagnostics and which was recently approved by the US Food and Drug Administration.
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.
FoundationOne CDx is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.
It 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.“Our mission to transform cancer care includes partnering with biopharma companies to expedite development of personalized treatment options for patients. We are proud to partner with Pfizer who shares our commitment to precision oncology and biomarker-driven drug development,” said Melanie Nallicheri, chief business officer and head of biopharma at Foundation Medicine. “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.”
