AACC Issues Position Paper on Regulation of Laboratory Developed Tests

Another industry trade group has chimed in on the issue of the U.S. Food and Drug Administration (FDA) regarding its intent to regulate laboratory developed tests (LDTs). The American Association of Clinical Chemistry (AACC) issued a position paper urging the FDA to give up its effort to regulate LDTs and instead strengthen the existing CLIA regulations. The FDA has proposed regulating LDTs in recent years, raising concerns that the complexity of the tests could put patients in danger if they are not properly interpreted. It has issued proposed guidelines for regulation over the objection of virtually all of the laboratory sector. In its position paper, the AACC made the following recommendations:

• LDTs should be defined as new or significantly modified tests for which the modification alters the clinical claims

• CLIA should be updated to require laboratories to demonstrate that LDTs are clinically valid for use in medical decisions

• The Centers for Medicare & Medicaid Services (CMS) should credential third-party organizations to review a laboratory’s clinical validation data for LDTs

• CMS and deemed accrediting organizations should include on inspection teams individuals with expertise to evaluate LDTs

The AACC’s position is similar to that of other trade groups in the laboratory space, including the American Clinical Laboratory Association. However, the AACC has gone the farthest in terms of articulating a specific alternative to the FDA regulating LDTs.

“Clinical labs have one of the lowest error rates in healthcare, showing that CLIA has done an excellent job of regulating labs so that clinicians get the quality test results they need to make critical decisions about patient treatment,” said AACC Chief Executive Officer Janet B. Kreizman in a statement. “AACC urges Congress and CMS to update the already rigorous CLIA framework, as we firmly believe this is the most effective way to improve oversight of laboratory-developed tests while still fostering innovation and enabling labs to meet the changing needs of patients.”

Takeaway: The AACC is joining the chorus of laboratory groups objecting to the regulation of laboratory developed tests by the FDA, but has issued an extensive alternative.