The performance of predictive genetic tests should be restricted to laboratories with expertise in genetics and demonstrated proficiency in genetic testing. Although one is in place for cytogenetics, none exists for molecular genetics or biochemical genetics. With a genetics specialty under CLIA, personnel requirements for laboratories performing genetic tests could be established, as could requirements for proficiency testing. Having a specialty would not, however, address the Task Force s concerns about the clinical validity of genetic tests. Summary The following reflect our primary concerns and recommendations about the ASR proposal.
Genetic tests have many intended uses.
When an ASR has the capability of predicting inherited disease in healthy or apparently healthy individuals it must not receive a Class I classification, exempt from premarket notification. FDA should establish a Genetic Test Devices Panel under its Medical Devices Advisory Committee. Such a panel could assist FDA in determining whether an ASR could be used for predictive genetic testing. FDA should consider how it can expedite assessments of safety and effectiveness of predictive genetic tests that are provided in-house. Unless otherwise noted, it should be indicated that the safety and effectiveness of the test have not been established.