Senate HELP Committee holds hearing on laboratory developed tests

The Senate Health, Education, Labor & Pensions Committee today held a hearing on laboratory developed tests, which are developed, validated and performed by individual laboratories, including hospital laboratories, when commercial diagnostic tests do not exist or meet clinical needs. In comments submitted to the Food and Drug Administration last year, the AHA expressed concern that the agency’s draft framework for regulatory oversight of LDTs, “while well-intentioned, is inappropriate and will lead to a loss of patient access to many critical tests.” Instead of subjecting clinical laboratories to multiple oversight agencies, AHA said “a better approach” would be to modernize and enhance the Clinical Laboratory Improvement Amendments. During the hearing, Committee Chairman Lamar Alexander (R-TN) said FDA regulation of the tests would amount to “unnecessary double regulation” and most hurt “Americans who stand to benefit from the rapid pace of science and discovery.” Testifying at the hearing were representatives from Memorial Sloan Kettering Cancer Center in New York; NorthShore University HealthSystem in Evanston, IL; BD Life Sciences; and Friends of Cancer Research.