By Kirell Lakhman

Some clinical labs would be required to register certain of the genetic tests they perform with a "mandatory" database crafted and overseen by the federal government, according to recommendations released by the Genetics & Public Policy Center at Johns Hopkins University.

GPPC says the registry, which would "impose civil and criminal penalties for non-compliance," would be part of an effort to "increas[e] the quality and transparency of genetic testing."

All clinical labs would be required to register, GPPC says in a statement released Monday.

The call for such a database comes more than one year after the Secretary's Advisory Committee on Genetics, Health, and Society recommended creating one. That suggestion has so far come to nothing.

Taking its place in the queue to create a mandatory test registry, GPPC concedes that such a database "on its own would not close [the] gap" between the "increasing availability and complexity" gene-based tests and available methods to oversee or regulate them."

However, such a registry would be "a critical first step in the development of a more transparent, quality-centered system of oversight that will better inform and protect the public," GPPC says.

A study detailing the registry plan appears in the current Public Health Genomics. It was released online June 30. Here's the abstract.

According to GPPC, the registry "should be mandatory, with penalties imposed for noncompliance." Also, "for practical reasons, the registry initially should be limited to genetic tests that are health related," though "providers of tests for ultra-rare disorders would be exempt from some reporting requirements that could be unduly burdensome."

The registry would also "contain information adequate to assess how reliable a test is (analytic validity), how the results relate to current and future disease risk or health status (clinical validity), and how useful the results are in informing patient diagnosis or treatment or in disease prediction, management, or prevention (clinical utility)."

GPPC identifies two "potential homes" for the registry: NIH, which has "extensive expertise in registry development and implementation, and FDA, which has "significant enforcement capability." FDA would also be responsible for enforcement because "it has the ability to impose civil and criminal penalties for non-compliance."