testtube2Personalized medicine relies on diagnostic medicine to identify the best therapy for the patient at the right time. Tests that match a therapy to the patient fall into one of two categories. In vitro diagnostic devices or IVDs are diagnostic tests developed and manufactured by device manufacturers. In the United States, IVDs are regulated by the U.S. Food and Drug Administration (FDA). IVDs that direct treatment decisions are considered by the FDA to be high risk and therefore require pre-market approval.

Diagnostic tests developed by a commercial laboratory, termed laboratory developed tests or LDTs are subject to oversight under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) administered by the Centers for Medicare & Medicaid Services (CMS).

The CLIA/FDA Debate

While FDA has the authority to regulate LDTs, historically it has not exercised jurisdiction over these tests. FDA’s announcement several years ago of its intent to regulate LDTs, was not universally welcome. In its 2013 Report Personalized Medicine Regulation: Pathways for Oversight of Diagnostics (reviewed in my post of February 24, 2013), the Personalized Medicine Coalition reported that there are significant differences of opinion among stakeholders on the optimal level of regulation of LDTs, especially when the outcome of an LDT impacts pharmacological intervention. Some stakeholders view FDA regulation of LDTs, in addition to CMS regulation, as creating a disproportionate burden on laboratories that would slow innovation to the detriment of physicians and patients, and would unnecessarily increase the cost of providing laboratory services. Other stakeholders opine that the current regulatory oversight of LDTs is insufficient in view of the increased complexity of the tests, and that a risk-based FDA approach can sustain and promote innovation while benefiting patient safety.

Point of Care Testing

While the IVD/LDT regulatory debate continues, a new wrinkle was noted by Bloomberg BNA Life Sciences & Industry Report “New Stakeholder Group Wants FDA to Reform CLIA Waiver Process” (Report and coalition) for point of care diagnostic testing. The Report notes that a newly formed stakeholder group wants the FDA to ease restrictions where low risk diagnostic testing can be performed. The Report explains that:

“According to the coalition, all laboratory tests must be reviewed by the FDA and assigned a complexity level (low/waived, moderate or high). The complexity level dictates where the test can be performed. Moderate- and high-complexity tests may be performed only in sophisticated laboratories that satisfy the strict requirements of CLIA (including personnel training, quality standards, proficiency testing and recordkeeping requirements, among others). If a user needs special laboratory expertise and training to run a test, its use needs to be restricted to nonwaived labs. But if the test can be performed in the hands of untrained users the same as trained users, then it should be allowed in a CLIA-waived lab.”

The Report also notes that the coalition is asking the FDA to change the way it interprets the CLIA law to put the emphasis on how effective the test is rather than its accuracy.

Impact on Personalized Medicine?

As technology advances, it is not improbable that some tests that guide treatment decisions will move from highly complex tests requiring specialized training and strict regulatory oversight to more routine tests of low complexity. Determining the appropriate level of regulation of point of care tests will need to balance patient safety, healthcare cost, and laboratory efficiency. Interested stakeholders should monitor developments and join the discussion to ensure the appropriate balance is achieved for the benefit of patients and the advancement of personalized medicine.