January 18, 2018 Source: invitrodiagnostics.medicaldevices-business-review 102
Pfizer has collaborated with Foundation Medicine for the development of companion diagnostics (CDx) for its oncology portfolio.
The firms will engage in the development, regulatory support and commercialization of FoundationOne CDx, which is a FDA-approved comprehensive genomic profiling (CGP) assay for all solid tumors that that integrates multiple companion diagnostics.
Pfizer will also use Foundation Medicine's data analytics platform, FoundationInsights, for novel biomarker discovery and enhance clinical trial design.
The combination of FoundationInsights and FoundationOne CDx will help Pfizer to speed up the accelerate discovery and development of precision oncology therapeutics.
Currently, Pfizer has 10 FDA-approved oncology medicines that can be used to treat a different solid tumors and hematologic malignancies.
The company’s oncology portfolio is also comprised of 17 products in clinical development and 19 phase 3 studies.
FoundationOne CDx is a next generation sequencing based in vitro diagnostic device to detect substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements.
It will also help to detect genomic signatures such as microsatellite instability (MSI) and tumor mutational burden (TMB) by using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens.
FDA has approved FoundationOne CDx 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 and ovarian cancer or breast cancer.
It will help to provide treatment for patients with one of 17 on-label targeted therapies.
Foundation Medicine biopharma head and chief business officer Melanie Nallicheri said: "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.”By Ddu
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