Currently Viewing:
Newsroom
Currently Reading
Foundation Medicine Applies for Parallel FDA and CMS Review for CGP Test
August 03, 2016 – AJMC Staff
The Risk of T2D in Individuals With Benign Adrenal Tumors
August 02, 2016 – AJMC Staff
Research and Clinical Updates on World Lung Cancer Day
August 01, 2016 – Surabhi Dangi-Garimella, PhD
This Week in Managed Care: July 30, 2016
July 30, 2016
Women Confident of Breast Cancer Treatment Decisions Following Online Support
July 29, 2016 – Surabhi Dangi-Garimella, PhD
Combining Local Peripheral Treatment With Ipilimumab Doubles Survival in Melanoma
July 28, 2016 – Surabhi Dangi-Garimella, PhD
Flatiron's EHR Platform for OCM Participants Promises to Foster Value-Based Care
July 28, 2016 – Surabhi Dangi-Garimella, PhD
Patient Access to Reference Pricing Prompts Choice of Lower-Cost Testing Laboratories, Cost Savings
July 27, 2016 – Surabhi Dangi-Garimella, PhD
Breakthrough for Daratumumab for Use as Second Line With Standard of Care in Multiple Myeloma
July 26, 2016 – Surabhi Dangi-Garimella, PhD

Foundation Medicine Applies for Parallel FDA and CMS Review for CGP Test

AJMC Staff
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 press release.

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.

 
Copyright AJMC 2006-2019 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up