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Received this announcement in my email today.
Food and Drug Administration
U.S. Department of Health and Human Services
November 30, 2017
Dear Colleague,
The U.S. Food and Drug Administration today approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The test is also the second IVD to be approved and covered after simultaneous review by the FDA and the Centers for Medicare & Medicaid Services (CMS) under the Parallel Review Program, which facilitates earlier access to innovative medical technologies for Medicare beneficiaries.
F1CDx provides patients and health care professionals with information regarding a large number of genes implicated in cancer for use in accordance with professional guidelines. Specifically, the F1CDx provides information on a variety of cancer mutation types in 324 genes and two genomic signatures. This is an important advancement, because it allows patients and health care providers to access all of this information in one test report, and avoid duplicative biopsies.
The Breakthrough Device Program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exist or that offer significant advantages over existing approved or cleared alternatives. Under this program, the FDA provides intensive interaction and guidance to the company on efficient device development, which expedites evidence generation and the agency’s review of these devices.
The Parallel Review program is a collaborative effort that is intended to reduce the time between FDA marketing approval or FDA's granting of a de novo request and Medicare coverage decisions through CMS's National Coverage Determination (NCD). Under this program, FDA and CMS concurrently review (“in parallel”) the clinical trial results submitted in the PMA and independently determined if the data met their respective Agency’s standards. Participation in Parallel Review is voluntary and does not change the existing separate and distinct review standards for FDA device approval or clearance and CMS national coverage determination.
For more information, see CDRH’s Approach to Tumor Profiling Next Generation Sequencing Tests.
Thank you,
Deborah J. Miller, Ph.D., M.P.H., M.S.N., R.N.
Cancer Patient Liaison
Office of Health & Constituent Affairs
Office of External Affairs
Food and Drug Administration
U.S. Department of Health and Human Services
November 30, 2017
Dear Colleague,
The U.S. Food and Drug Administration today approved the FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The test is also the second IVD to be approved and covered after simultaneous review by the FDA and the Centers for Medicare & Medicaid Services (CMS) under the Parallel Review Program, which facilitates earlier access to innovative medical technologies for Medicare beneficiaries.
F1CDx provides patients and health care professionals with information regarding a large number of genes implicated in cancer for use in accordance with professional guidelines. Specifically, the F1CDx provides information on a variety of cancer mutation types in 324 genes and two genomic signatures. This is an important advancement, because it allows patients and health care providers to access all of this information in one test report, and avoid duplicative biopsies.
The Breakthrough Device Program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exist or that offer significant advantages over existing approved or cleared alternatives. Under this program, the FDA provides intensive interaction and guidance to the company on efficient device development, which expedites evidence generation and the agency’s review of these devices.
The Parallel Review program is a collaborative effort that is intended to reduce the time between FDA marketing approval or FDA's granting of a de novo request and Medicare coverage decisions through CMS's National Coverage Determination (NCD). Under this program, FDA and CMS concurrently review (“in parallel”) the clinical trial results submitted in the PMA and independently determined if the data met their respective Agency’s standards. Participation in Parallel Review is voluntary and does not change the existing separate and distinct review standards for FDA device approval or clearance and CMS national coverage determination.
For more information, see CDRH’s Approach to Tumor Profiling Next Generation Sequencing Tests.
Thank you,
Deborah J. Miller, Ph.D., M.P.H., M.S.N., R.N.
Cancer Patient Liaison
Office of Health & Constituent Affairs
Office of External Affairs