There is a real problem with Lab Developed Tests (LDTs) in the...

There is a real problem with Lab Developed Tests (LDTs) in the US. The FDA has expressed concerns about the commercial exploitation of loose regulations by CLIA labs in recent years. Rather than alleviate the FDA and commercial companies of regulatory processes involved in launching simple invitro tests as intended, heavily funded CLIA labs are pushing diagnostic tests to new extremes, mainly utilising new DNA technology. Meanwhile, patients may well be subject to unnecessary high-cost tests, and potentially harmful procedures as a result.

Of particular concern is that the lab itself invents the test and performs its own clinical trials. There is a strong likelihood of bias.

There are many US LTDs for colorectal cancer, of which Glycoknow is just one. Various others, of questionable merit, as put forward by@borano

As we know, Colostat was developed by the CSIRO, commercialised by Rhythm Biosciences, tested by Sonic Healthcare, and soon to be approved by our TGA. Should it achieve a US CLIA lab partnership, by virtue of rigorous development, it's fair to say that the test itself has very strong integrity.

https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2019/05/what-are-in-vitro-diagnostic-tests-and-how-are-they-regulated#:~:text=These%20tests%20are%20regulated%20by,before%20bringing%20it%20to%20market.

"FDA has historically viewed LDTs as posing a lower risk to patients than most commercial testing kits, and has exempted them from nearly all regulatory requirements under the Food, Drug, and Cosmetic Act. As such, the agency does not review these tests to ensure that they are accurate and reliable, and their exact number is unknown. Reporting to FDA is voluntary; there is no single registry of all laboratories that utilize LDTs, so estimates vary widely. While FDA has estimated that 650 laboratories develop these tests,7 the American Clinical Laboratory Association has said that the majority of the 11,633 laboratories permitted to develop and perform LDTs do so."

"Tests are no longer hyperlocal or just for rare diseases. LDTs are being developed by large, commercial organizations and performed for patients across state lines. These tests have also been developed for a wide range of conditions, and are increasingly being used in precision medicine to diagnose or guide treatment for serious conditions. Faulty or misleading results could now affect a broad range of patients, magnifying the potential for harm."

"Providers and patients rely on clinical tests to inform their treatment decisions. But while technology has advanced and the way providers use diagnostic tests has evolved, the oversight framework has remained largely unchanged. IVDs and LDTs often serve the same role in clinical practice, but are subject to far different levels of oversight. This creates distortions in the diagnostics market, prevents regulators from having a comprehensive understanding of the tests used in clinical practice, and puts patients at increased risk of making consequential and perhaps irreversible medical decisions on the basis of inaccurate test results."