ACLA announced that it has submitted a detailed, 107-page comment letter to the FDA, in response to the FDA's proposal to regulate lab developed tests. Here.
At several points the comment extensively discusses and highlights MolDx. Here they are:
IN THE BODY OF THE LETTER
The clinical validity of tests is also closely scrutinized by both public and private payers. For example, the Molecular Diagnostic Program (MolDX) provides Medicare coverage for molecular diagnostic tests, including LDTs, only once those tests have demonstrated analytical validity, clinical validity and clinical utility. To obtain coverage, laboratories must submit dossiers with scientific information to demonstrate these standards and the requirements of the specific coverage determination are met, and those dossiers are reviewed by unbiased subject matter experts. The MolDX program has been adopted in 28 states and additional US territories, and according to MolDX, most molecular labs in the United States operate within its jurisdiction. MolDX reviews over 1,500 tests per year, and it has reviewed approximately 20,000 tests, a vast majority of which are LDTs, to date since the program was established in 2011....
Accordingly, it is simply false to refer to LDTs as unregulated, inadequately regulated, or unscrutinized. High-complexity laboratories are subject to multi-layered regulation, and individual LDTs are scrutinized by federal regulatory regimes (CLIA), state regulatory regimes (state clinical laboratory laws), accrediting organizations (e.g., CAP), proficiency testing entities, federal coverage programs, private payers, and individual clinicians in search of the best care for their patients.