Expanding companion diagnostics, Pfizer accelerates the development of precision tumor therapy
January 18, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];WuXi PharmaTech partner Foundation Medicine recently announced that it has established a wide-ranging partnership with Pfizer. The focus of the collaboration is on the development, regulatory support and commercialization of companion diagnostics (CDx), which will include updates to FoundationOne CDxTM. Foundation Medicine's FoundationOne CDx is an FDA-approved comprehensive genomic profiling (CGP) for all solid tumors with multiple companion diagnoses. Pfizer will also benefit from Foundation Medicine's data analysis platform, FoundationInsightsTM, to facilitate the discovery of new biomarkers and optimize clinical trial design. The unique combination of FoundationInsightsTM and FoundationOne CDx will make it possible for Pfizer to leverage Foundation Medicine's platform technology to accelerate the discovery and development of precision oncology.
Pfizer currently has 10 FDA-approved oncology drugs for a variety of solid tumors and hematologic malignancies. In addition, its oncology pipeline includes 17 clinical R&D products and 19 Phase 3 clinical phase products.
FoundationOne CDx evaluates changes in all of the 324 genomes known to promote cancer growth genes, providing potentially viable information to guide treatment decisions. It also reports on genomic biomarkers, such as microsatellite instability (MSI) and tumor mutation load (TMB), which contribute to the choice of immunotherapy. In addition, it provides additional genomic alterations related to patient management, as well as relevant clinical trial information. Therefore, it is designed to help simplify the development of companion diagnostics, reduce risk and advance targeted therapeutic development. The FoundationOne CDx is currently approved by the FDA as a CGP test for all solid tumors, as well as a wide range of companion diagnostic methods for certain types of non-small cell lung cancer, melanoma, colorectal, ovarian or breast cancer patients to identify patients. May benefit from one of 17 label-targeted therapies.
At the same time as the FDA approved, the Centers for Medicare and Medicaid Services (CMS) issued a preliminary National Coverage Measurement (NCD) for the FoundationOne CDx. The NCD draft will cover FDA-approved companion diagnostic requirements and provide evidence for additional coverage of other solid tumor types. The final policy is expected to be announced in the first quarter of 2018.
â–²Ms. Melanie Nallicheri, Chief Business Officer and Head of Biopharmaceuticals, Foundation Medicine (Source: Foundation Medicine)
“Our mission to change cancer care includes working with biopharmaceutical companies to accelerate the development of personalized treatment options for patients. We are pleased to work with Pfizer, Pfizer's commitment to precision oncology and biomarker-driven drug development. "Consistent," said Melanie Nallicheri, chief medical officer and head of biopharmaceuticals at Foundation Medicine. “We have an FDA-approved comprehensive genomic analysis platform and molecular information solutions, and Pfizer's strong portfolio of oncology products enables us to increase the impact of precision oncology to advance patient care.â€
Reference materials:
[1] Foundation Medicine, Pfizer Pen Companion Diagnostics Deal
[2] Foundation Medicine official website
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