FDA has produced a document (1) outlining the issues with just a few LDTs. These tests are prolifertaing because of the hype about genomics and "precision medicine," whatever that is. The FDA document illustrates some of the astoundingly audacious misuse of statistical manipulation to present faulty claims about various LDTs.
DAIA is a congressional proposal to regulate these LDTs, which are called IVCTs (in vitro clinical tests) in the proposed law. In addition to regulating LDTs, the law also folds in areas currently regulated by FDA: manufactured test kits and testing instruments. The proposed law offers an extraordinarily generous five-year phase-in to allow IVCT developers to get their act together plus an additional 2 years to come into compliance.
I love the idea that medical labs foisting these LDTs on the public will be held to the same standards that commercial manufacturers must meet. Laboratory organizations predictably do not like this proposal(2,3). Professional societies interested in infectious disease testing also want a "public health exemption" so that they can put in place whatever tests they want for infectious disease outbreaks (3).
I am completely opposed to labs getting a "public health" loophole to put shoddy testing into place. I have personally seen labs testing (one of which is mentioned in the FDA document, ref. 1) for infectious disease utilizing poorly documented performance studies and virtually non-existent clinical studies. This is not to say that problems don't arise using test kits that are FDA approved, since I have seen plenty of problems using those materials as well.
Some organizations, such as the American Association for Clinical Chemistry (AACC) are strident in their opposition to the proposed law (2). This organization states that the law would: 1) foster an anti-competitive environment; 2) stifle test innovation; and 3) hinder patient care.
Yikes, could be the end of the world if we start to regulate the wild west of lab tests.
But will it be that bad? I mean right now the FDA is approving tests for which the only public information available is abstracts from presentations at medical meetings (see posting of 7/27/17). Who knows how much data is being required by the FDA.
I would prefer that labs or anyone else wanting to offer an IVCT should publish the findings for public analysis and comment, the information obtained then being reviewed by an FDA oversight entity which would determine whether the IVCT warranted approval. This method would limit growth of yet another federal bureaucracy and put more power into the hands of health care consumers.
Read Much More About Laboratory Developed Tests And Over-Diagnosis in My Book “Blood Trails…”
3. AACC letter Re: Laboratory Developed Tests and The Diagnostic Accuracy and Innovation Act, April 6, 2017.