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Foundation Medicine Applies for Parallel FDA and CMS Review for CGP Test
Foundation Medicine’s comprehensive genomic profiling (CGP) assay has been submitted by the company for FDA review as well as for a CMS review in parallel.
Foundation Medicine’s comprehensive genomic profiling (CGP) assay has been submitted by the company for FDA review as well as for a CMS review in parallel, according to a company
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The FoundationOne CGP assay for cancer can evaluate genomic alterations in 324 genes from formalin-fixed tissue samples mounted in paraffin. CGP is tasked to detect substitutions, insertions and deletions, copy number alterations, and select gene rearrangements using next-generation sequencing, which could prove a big benefit for patients who have developed solid tumors. A bigger advantage thought would be the precision medicine plan that could eventually be developed to match the patient with appropriate treatment.
The company’s chief executive officer Michael Pellini, MD, said, “The acceptance of FoundationOne for EAP and Parallel Review is a significant advancement towards the achievement of precision medicine, enhancing patient access to targeted therapies and clinical trials.” He added that Foundation Medicine will continue to work with Palmetto GBA to expand coverage of CGP assays, currently restricted to patients with non-small cell lung cancer.
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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Oncology Onward: A Conversation With Penn Medicine's Dr Justin Bekelman
December 19th 2023Justin Bekelman, MD, director of the Penn Center for Cancer Care Innovation, sat with our hosts Emeline Aviki, MD, MBA, and Stephen Schleicher, MD, MBA, for our final episode of 2023 to discuss the importance of collaboration between academic medicine and community oncology and testing innovative cancer care delivery in these settings.
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Trastuzumab Deruxtecan Receives FDA Approval for HER2-Positive Solid Tumors
April 5th 2024FDA granted accelerated approval to trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive solid tumors who received prior systemic treatment and have no satisfactory alternative treatment options.
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