Under an AdvaMed plan for expanding FDA regulation of diagnostic tests, tests that consist of new or unproven biomarkers on new technology platforms would likely require a pre-market approval application.

Tests that use established biomarkers and technology platforms, tests for rare diseases, and rarely-used tests would be exempt from FDA pre-market submissions under the proposal.

The device trade group submitted its detailed, risk-based ¹ plan for expanding federal regulation of all diagnostic tests, including those developed by clinical labs, to FDA's device center on March 27.

The proposal, a "work in progress" according to AdvaMed, divides tests into four regulatory "tiers" based on risks associated with clinical use of the test, novelty of the analyte and the technology, and training of the intended test operator.

Tier III products represent the highest risk to health if the tests should fail; Tier II products have some manageable risks and will likely require 510(k)s; Tier I products may require a 510(k) or just a labeling review; and the lowest-risk Tier 0 products may or may not require labeling review.

In FDA's current paradigm, new technologies are competing with older, well-standardized tests for scant review resources, AdvaMed says.

"FDA should not be spending its scarce resources reviewing old technology that is well-understood," the March 27 proposal states.

The new model will allow patients to benefit sooner from new technologies, AdvaMed says.

The group has also been working on a list of additional Class I and II devices that should be exempt from pre-market review. AdvaMed plans to submit the list to FDA this spring.

Plan Includes Lab-Developed Tests

AdvaMed's proposal is also meant to address calls from diagnostic makers and some government advisors for greater FDA oversight of tests developed and used by clinical laboratories.

Traditionally FDA has not regulated these products; some question whether the agency even has the legal authority to do so (² Also see "Would Expanded Lab-Test Regulation Overstep FDA’s Legal Limits?" - Medtech Insight, 16 March, 2009., p. 13).

Lab tests are subject to CMS oversight under the 1988 Clinical Laboratory Improvement Amendments, and may be subject to state laws and professional society-established standards.

But some public health experts worry that CLIA only evaluates the quality of lab testing, not the safety and efficacy of each specific test (³ Also see "FDA Genetic Test Oversight Is On The Rise, But How Far Can It Go?" - Medtech Insight, 25 February, 2008., p. 14). Diagnostic test kit manufacturers have pointed out that the system offers an unfair advantage to lab-developed tests.

Laboratories and some upstart diagnostics firms that launch tests via internal CLIA-certified laboratories oppose broader FDA oversight (⁴ Also see "FDA Genetic Test Oversight Is On The Rise, But How Far Can It Go?" - Medtech Insight, 25 February, 2008., p. 14).

Under AdvaMed's proposal, clinical labs would still be subject to CLIA requirements and quality standards - in addition to potential FDA review.

"An important aspect of this discussion will be harmonization for FDA quality system and Clinical Laboratory Improvement Amendment (CLIA) regulations," the proposal states.

Dx Reimbursement Is Next On AdvaMed's List

AdvaMed plans to follow up the diagnostics regulation proposal with suggestions on how reimbursement of new assays can be improved.

The association has backed unsuccessful legislation in previous Congresses to update the Medicare process for determining payment levels for new tests or, at least, to initiate a demonstration project to explore news ways of paying for molecular diagnostics (⁵ Also see "Industry Sees Room For Better Diagnostics Payments In Medicare Package" - Medtech Insight, 10 December, 2007., p. 13).

In an interview, AdvaMed President and CEO Steve Ubl said the group plans to issue a new proposal on the topic in the "next couple of weeks," with the hope that its ideas will ultimately be folded into comprehensive health reform legislation that surfaces this year.

- Jessica Bylander (j.bylander@elsevier.com)

AdvaMed Wants Across-The-Board Risk-Based Regulation For Diagnostics

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