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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
.
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.
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
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Uniting to Support Patients With Cancer Beyond Treatment
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Bridging Cancer Care Gaps and Overcoming Medical Mistrust
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How English- and Spanish-Preferring Patients With Cancer Decide on Emergency Care
November 13th 2024Care delivery innovations to help patients with cancer avoid emergency department visits are underused. The authors interviewed English- and Spanish-preferring patients at 2 diverse health systems to understand why.
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