Monday, December 4, 2023

ACLA Comment to FDA…it Includes MolDx!

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: 


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.   


FDA  could  recognize  approvals  by  New  York  State  and  coverage  decisions  by  MolDX  as  clearances and approvals of LDTs for purposes of device regulation to reduce, but not eliminate, the  net harm of the rule.  

As detailed above, both of these programs review LDTs for their analytical and  clinical validity based on detailed technical submissions.  Accordingly, FDA could reduce, but not  eliminate, net harm from the rule by recognizing their decisions as satisfying the FDA requirement  for clearance or approval by exercising enforcement discretion for tests that have gone through such  programs, or, at minimum, structure an expedited approval/clearance pathway that would alleviate  the burden of FDA re-review of such tests.  Likewise, with respect to LDT clinical trial assays that  New  York  State  permits  to  be  used  for  clinical  management  without  prior  approval,  FDA  could  reduce the net harm of the rule by continuing enforcement discretion with respect to such clinical  trial assays.