On February 1, 2024, Friends of Cancer Research ran a half-day workshop on diagnostics, regulation, and advances. Find it here, "The Future of Diagnostic Tests:"
https://friendsofcancerresearch.org/event/the-future-of-diagnostic-tests/
SHUREN SPEECH ON LDT
The opening keynote was by FDA's head for devices, Jeff Shuren MD JD.
- Read about Shuren Speech in my bullet points.
- I've taken live bullet point notes and post them below. "Quinn notes on Shuren Speech."
- Read about Shuren Speech in an "AI Article."
- Instead of my own bullet points below, oyou can read them "converted" into an article by AI here.
CALIFF, FDA COMMISIONER: SPEECH ON LDT
See also a Dr Califf speech yesterday that FDA is moving full speed ahead with LDT regulation.
https://www.medtechdive.com/news/fda-califf-backs-ldt-proposed-rule/706286
FDA DOWNREGULATION OF RISK
Dr Shuren highlighted a MAJOR posting yesterday about the intent to reclassify risk for many diagnostic tests:
Jeff Shuren FDA
My comments are limited due to rulemaking.
We have authorities over all tests, whoever makes them.
50 years ago we deferred regulation of LDTs, simple locally produced tests.
We have now seen LDTs that are not clinically valid, across diseases and in oncology.
We’ve also seen impacts on innovation, hurting the incentives for some IVD diagnostics since laboratories copy them, often with LDT claims of superiority. This disenfranchises the IVD, and that has to change.
With reports of test variability, your cancer treatments depends more on the lab you use, not your cancer biology.
A decade ago we had a series of guidances. We got feedback in favor of a modern legislative framework and we worked on that for 7 years (Biblical!). The path for legislatiion is unclear.
To move forward for patients, we did a regulation last falll. And we did an economic analysis, we didn’t have to. In the rule itself, it phases out enforecement discretion. It leaves discretion for some tests, and asks how broad any discretion should be. We asked about “tests on the market,” and “emerging pathogens” and ‘small entities” and a longer phase out period. AMC’s were uniquely concerned, in their terms. And they provide “integrated healthcare for unmet needs.” And some programs like NYS DOH provide pre market review. We got lots of comment, 6500 but many “form letters.” From a wide range of stakeholders, with perspectives from A to Z.
We are moving forward to finalize the regulation.
We hav a challenge with tests used to inform drug treatment where there is or will be a CDx. We have a pilot program for drug companies and labs to use, providing info on LDTs that match the pivotal study (”LDT”) tests used in the drug trial. That is an interim step. We will evaluate in June 2026. The pilot hasn’t actually launched for any company. It requires a collaborating pharma and a colloborating FDA lab.
Yesterday, we announced our intent to reclassify MOST high risk tests to what we call “moderate risk tests” with appropriate mitigations. This streamlined approach will stimulate innovation and these will often be for infectious disease and companion diagnostic. Other tests may also move from high to moderate risk. This would involve rulemaking and advisory panels.
We also have the TPLC Total Product Life Cycle advisory program. TPLC AP or TAP. There are many hurdles in device development, of which FDA is just one step. In Med Tech, developers don’t fully account for all the aspects of evidence strategy, even sophisticated players. And include the voice of patients.
These include the needs of payers, years, for innovative technology. We want to ensure interest in investment, with TPLC TAP. You can meet with us and bring your questions. We did this fluidly with EUAs in COVID, more fluid engagements. You might even talk several times per week to FDA.
We’ll help connect you to patients, provider, payer groups. The pilot is launched, and we strated with cardiovascular, and then added neurologic and rehab. It will in time include diagnostics. Feedback “very very positive.” We want to improve predictability and reduce the cost of “valley of death” in R&D.
Finally. Health equity is a strategic priority. We want to address gaps across populations. CDRH focuses on “access.” There are many intrinsic challenges - fragmented, costly health, with innovation not reaching patiens, we pay more and live less long. We can’t focus just on “care” for the sick, and just “brick and mortar.” We need prevention and movable care from institutions to people at home.
This isn’t just “dumping” tech from hopsital to home, that’s “jerry rigged.” It is unmanageable that way, it has to be re-thought and fit for purpose.
And as we move these technologies to remote locations, we also have great opportunities to gather data. See our “Docket” on Home Use devices. This is a priority for our center, see also the CDRH DHCE Digital Health Center of Excellence. We’ve authorized 650 AI or ML devices.
These affect imaging, diagnosis, and eventually devices in treatment. It won’t be CT scan at home, but may be AI guided ultrasound. Design the technology for people, and consider consumer technology that is “medical grade.”
Home use tests - IVDs. In COVID, the US now is comfortable with OTC tests. They existed before COVID, but witih lots of concerns (outside of home pregnancy) COVID has changed that, and we see more OTC tests coming to use, from infection to drugs of abuse, but they need design for home users.
COVID tests were “fine” but what about someone with arthritis (fine packaging and squeeze drops). We would like to see oncology tests in the home, too, finding cancer early and making a huge difference and with wide access including home.
Home use tests for “clinical trial in a box.”
Partners. If you want to go far, do it together. We have collaborative communities, or CC. USCDI+ Cancer Inititive. Cancer Moonshot. Cancer X. Public meetings (such as on skin lesion technologies). If we are a representative government, we need this stakeholder participation (not just AMCs, but patients). We don’t run a “CC” collaborative community, we listen and adapt from those.
There’s a Pathology Innovation CC and a Digital Measurement CC, and we have about 15 of these.
Q&A
CLIA and NY State.
CLIA and NYS. Jeff seems to say that half of NYS tests don’t pass on first submission. We’ve had that with LDTs too. We don’t question that LDT has some role in healthcare, but must be accurate and reliable. There are similarities between us and NYS.
Mark Fleury ACS CAN. The oncology pilot? Performance standard for LDT, and cases where no IVD CDX is around yet. Could that tie to enforcement discretion? Shuren: A lot went into that announcement. The actions we take will take time (years) and we view the pilot for those as an interim step, but as I said it’s “in neutral” gear right now.
