Latest AACC Position Statements
Modernization of CLIA
In response to calls for the Food and Drug Administration to regulate laboratory-developed tests, AACC strongly recommends that the Clinical Laboratory Improvement Amendments (CLIA) remain the primary mechanism for overseeing these tests. CLIA has a proven track record of ensuring that labs provide accurate test results that enable patients to receive the care they need, and its regulations can easily be modified to enhance oversight of laboratory-developed tests without endangering patient access to this indispensable service.
Direct-to-Consumer Laboratory Testing
DTC laboratory testing is a key element of ongoing efforts to increase individuals’ engagement in managing their healthcare, and it is critical that DTC test results are accurate and well understood. Laboratory professionals play a vital role in this process.
Advancing Personalized/Precision Medicine
Laboratory medicine is key to enabling the practice of precision medicine. Policymakers and payers should adopt policies that ensure access to and appropriate reimbursement for laboratory testing that will facilitate personalized therapeutic decisions.
Oversight of Laboratory Developed Tests
Laboratory Developed Tests provide timely, accurate, quality testing for many conditions for which no commercial test exists or when an existing test does not meet current clinical needs. The regulation of LDTs should remain under CLIA’88 and its deemed accreditation bodies, except for certain high risk tests that should be subject to both FDA and CMS oversight.