Genetic Diagnostics

Regulatory:

Genetic diagnostics do not require approval by the FDA in order to go to market if the tests are Laboratory Developed Tests (“LDTs”), which are regulated under the Clinical Laboratory Improvement Amendments (“CLIA”). It is estimated that of the 2,000 genetic tests commercially available less than a dozen were reviewed by FDA. The American Clinical Laboratory Association (“ACLA”) filed a citizen petition on June 4, 2013 challenging the FDA’s authority to regulate LDTs as medical devices under the federal Food, Drug, and Cosmetic Act (FDCA). The ACLA stated, “CLIA allows laboratories the flexibility to develop and validate LDTs quickly to respond to public health needs.” The ACLA also wrote, “Laboratories are able to update LDTs regularly as medicine advances, so that patients have access to the most advanced testing.” LDTs are laboratory services, not products, and are not distributed, nor delivered or placed into market, noted the petition. “They are proprietary procedures for performing a diagnostic test using reagents and laboratory equipment, essentially know-how.