The Food and Drug Administration on Thursday formally recognized a public database that contains information about genes, genetic variants and their relationship to disease.
Genetic test developers can use the “free and reliable” database to submit premarket submissions for marketing to help improve better genetic testing for patient health, medicine, and scientific research. The FDA’s recognition of the public database, known as “ClinGen,” would make it the “go to” database for genetic testing developers.
“Developers of genetic tests have the assurance of the reliability of the freely available data that they can use in support of their applications for marketing authorizations with the agency, rather than generating the same data on their own,” states the FDA’s announcement.
As nation’s reliable genetic variant database, ClinGen becomes the reliable genetic databases and developers will not need to demonstrate to the FDA the reliability of the database’s genetic variant information which “can be used to support the relationship between a gene variation and a specific disease that are within the scope of the recognition,” according to the FDA.
Genetic tests work by looking at a person’s DNA to detect specific gene variations that can determine whether a person is at risk of developing a particular genetically linked disease.
Unlike traditional diagnostics that typically detect chemical changes associated with a single disease or condition, DNA-based testing can look at hundreds to millions of DNA changes in a single test to help determine the cause of a person’s disease or condition.
Availability of these types of tests plays a critical role in improving how clinicians and researchers learn about diseases, how innovators develop new treatments, and how doctors improve patient care.