[Genetic Alliance Director of Genetics and Health Policy Kristi] Zonno said FDA should create a public registry for genetic tests to “enable transparency and promote informed decision making for consumers and providers.” She said that registry “could and should include the myriad of genetic, genomic, and pharmacogenomic testing available to the US market.”
Open to the public, the registry should at the very least include the name of the lab performing a test, the name of the test developer, and information to support the test’s usefulness in obtaining results and improving clinical care, Zonno added.
This move is long overdue – there have been discussions of the need for such a database in many circles for well over a year, but there has been no visible progress yet. This is an enormously complex industry, and consumers need guidance from independent bodies (certainly more than they need over-zealous regulation of the industry). If Genetic Alliance can convince FDA to make a real effort here that would be a major step in the right direction.