ClinGen Gets FDA Recognition
The US Food and Drug Administration (FDA) announced ClinGen as the first FDA-designated public genetic variants repository this week.
What does this mean? Well, put simply it means that companies and laboratories developing genetic tests can use the data held in ClinGen to support their claims, cutting out the need for additional FDA reviews.
This is all part of the push from the agency to create a flexible and adaptive regulatory approach to the oversight of next generation sequencing based tests. Something which has been sorely missing, and is extremely welcome. The FDA will continue to make progress here as their Human Variant Database Program strives to ease the transition towards precision medicine.
“Technological and clinical advances in genetic tests mean that patients and providers have a better understanding of the causes of disease and potential treatment options. The availability of genetic tests is opening up new opportunities to segment illnesses into more treatable subsets and enabling the development of targeted therapeutics aimed at these previously unknown categories of disease. These new medicines increasingly show outsized benefits in small populations of patients with rare, hard-to-treat and sometimes fatal conditions. The ability to use diagnostics to identify these rare subsets is a key element in driving this transformation in medical care and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA is committed to supporting the development of these novel technologies that provide critical, potentially life-saving information. With our policies, we’ve sought to create an efficient regulatory pathway that promotes the more rapid development of important tests that can transform medical care while assuring their accuracy and clinical relevance. Our continued efforts, including today’s recognition, will advance this process and help patients gain access to more sophisticated tests that provide important genetic information, allowing for more targeted medical care.”
“A major current challenge for precision medicine is the need to translate new discoveries and data from the Human Genome Project so that this information can be used by physicians and other health care providers to improve health,” said NIH Director Francis S. Collins, M.D., Ph.D. “ClinGen provides a standard curated data reference of genetic variants to facilitate the development and implementation of genetic tests for use by health care professionals, which is critically important for moving science into practice.”
A big congratulations to the ClinGen team!