FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part I)

By Rachel Sachs

Over the past several months, I’ve been blogging (here, here, and here) about the FDA’s recent forays into regulating laboratory-developed tests (LDTs).  Since the release of the draft guidance framework in October, serious arguments have been made on opposing sides of the issue, and industry groups have made additional moves in opposition to the proposed regulation.  And now, today (and tomorrow), the FDA is holding a public workshop on their draft guidance framework, focusing on a wide range of issues.

Today’s workshop featured sessions on three main issues: 1) labeling considerations, 2) clinical validity and intended use, and 3) categories for continued enforcement discretion.  Many commenters simply presented the unique concerns of their organization and urged the FDA to consider them in finalizing the guidelines, which was helpful when it did seem as if the draft guidance may have insufficiently considered the needs of a particular set of laboratories, such as public health laboratories that focus on testing for infectious diseases like Ebola and chikungunya (about which I’ve also blogged, here and here).

More helpful, though (at least in my view), were the comments of those who sought to provide concrete recommendations for the FDA on the basis of 1) the policy concerns they saw underlying the guidance and 2) the practical effects of implementation that they foresaw.  I’ll illustrate with an example, which hopefully will display the complexity inherent in even the simplest questions that the FDA must answer here.

Historically, the FDA did not regulate LDTs because they were 1) relatively simple tests, 2) involved well-known scientific principles, and 3) were performed by doctors or pathologists responsible for taking care of the patient.  The FDA calls these “traditional LDTs,” and they have in mind tests like a Pap smear or a complete blood count.  But many new LDTs do not seem to match this model, like complex genomic tests.  The FDA would like to subject the latter to premarket review requirements, while allowing continued enforcement discretion over the former.

The challenge for the FDA, though, is to define specific criteria delineating these two groups.  Much of the lifting is done by its criterion that a “traditional LDT” must be “interpreted by qualified laboratory professionals without the use of automated instrumentation or software for interpretation.”  But at the hearing today, there was extensive debate over another the delineating factor the FDA has proposed: “whether [the test] is manufactured and used by a health care facility lab … for a patient that is being diagnosed and/or treated at that same health care facility or within the facility’s healthcare system.”  This criterion is clearly related to the FDA’s historical conception of LDTs as described above.  But several commenters noted the potential for this criterion to affect the way in which laboratories and hospitals choose to structure their testing facilities, offering examples of ways in which “health care facility” might be defined either narrowly or broadly.

The valence of this argument is not apparent.  A narrow definition of “health care facility” that encourages in-house cultivation of laboratory capacity might be praised for the connection it fosters between pathologists and patients, or it might be criticized for creating fragmentation and inefficiency.  A broad definition of “health care facility” that incorporates seemingly disparate entities might be praised for the way in which it permits the cultivation of expertise, or criticized for leaving too many LDTs insufficiently regulated.  And because the organization of healthcare is changing independently of the FDA’s actions, it might be prudent to stay out of the issue entirely.  As much as I hate to admit it, the views of one panelist seem to sum up the situation: “Whatever you come up with for a definition, you’re going to be criticized. This is impossible.”

On that cheerful tone, stay tuned for Part II of this blog post, recapping the highlights of Friday’s panels!

One thought to “FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part I)”

  1. And where do tests with the highest risk fit in? The consequences of a false forensic test can be far-reaching, grave and permanent. The majority of drug and alcohol testing requires FDA approved testing, strict chain-of-custody and MRO review. Specificity is the most critical component and prohibit false-positives. They should be close to nonexistent as the Federal Workplace guidelines attempt.
    But in 2003 a group introduced the first “forensic” LDT, EtG, by pitching a minor metabolite discovered in the 1950s to NMS labs. No FDA approval requirement means no FDA oversight and since this time the ASAM has introduced an array of nail, hair, breath, urine and blood tests via the LDT route and using them for monitoring groups with little to no power (criminal justice, professional monitoring programs, etc.). I encourage you to read the ASAM White Paper on Drug Testing as it describes the use of these tests in virtually everyone. The ASAM proposes random suspicion-less drug and alcohol testing using these LDTs with no evidence base by using the doctor-patient relationship as a loophole to bypass MRO review and chain of custody as safeguards. The loophole is the Doctor-patient relationship which renders it “clinical” with the results being “assessment” and “treatment. Any assessment will be done at an “approved treatment facility” meaning ASAM 12-step facility. And with the new DSM-5 low bar criteria for substance use disorder (SUD) they lobbied for there is a high likelihood of that diagnosis being given. And part of the treatment will be more drug testing and lifelong abstinence with 12-step recovery.

    The ASAM white paper can be seen here:


    And the accountability and integrity of both the labs and those who are using (and introduce) these tests can be seen below. The attached documents show top down corruption at both a collecting lab (Quest) and a forensic drug testing lab (USDTL) and the ordering agency (PHS, inc.) The documents comprehensively show from collection to analysis and subsequent coverup the corruption involved in LDT forensic testing. Here Quest collected an ostensibly “forensic” specimen and, at the request of PHS, changed it to a “clinical” specimen to bypass chain of custody and sent it to USDTL with instructions to process and report it clinically. Quest kept it for a week under unknown conditions and sent the then fermented sample to USDTL. After obtaining the positive “clinical” specimen PHS sends a faxed request to change it back to “forensic” by adding a chain of custody and adding back the forensic iD # as unique identifier. They then report it as a positive. These documents need to be used to show the reality of LDT testing and how easily it is misused, the top-down corruption and corporate psychopathy of these groups. And if you do a public policy analysis of the ASAM you will find that their positions are inevitably accepted. The White paper will come to fruition unless we stop it as it is being done through sub-government methods well funded by the DAATIA and other special influence groups who have infiltrated regulatory medicine.–Michael Langan, M.D.


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