Congress Tackles Laboratory-Developed Tests

Both in vitro diagnostics (IVD) manufacturers and lab groups have floated different legislative responses to the Food and Drug Administration (FDA) plan for regulating laboratory-developed tests (LDTs), released September 2014. Now some members of Congress are moving forward with draft legislation that aims to resolve the impasse between FDA and the lab community by forming an entirely new agency center within FDA. Perhaps most significantly, the legislation would sever regulation of laboratory tests from their current status as medical devices. The proposal comes out of the House Ways and Means Committee and would classify all IVD tests—including LDTs—into high, moderate, and low-risk categories for FDA oversight. However, FDA’s purview over LDTs would be narrowed compared to its current draft proposal, and many existing LDTs would likely be grandfathered with limited review.

The bill closely follows a regulatory framework put forward by the Diagnostic Test Working Group, whose members reportedly included ARUP Laboratories, Becton Dickinson, LabCorp, Mayo Clinic, and Roche. The American Clinical Laboratory Association, which represents many of the nation’s large independent labs, issued a letter to the committee emphasizing the organization’s support for grandfathering current LDTs from premarket review and no longer defining IVDs as medical devices, among other provisions.

AACC Issues Position Statement on Direct-to-Consumer Testing

Noting a paradigm shift among consumers who are seeking greater access and control in their own healthcare, AACC issued a position statement on direct-to-consumer­ (DTC) laboratory testing that emphasizes DTC test results must be accurate and well understood—an area where laboratory medicine professionals play a vital role.

In order for patients to benefit from greater access to DTC testing, AACC urges the Centers for Medicare and Medicaid Services and the Food and Drug Administration to require that DTC providers disclose sufficient information about their products and services, enabling consumers to make fully informed health decisions. DTC providers should employ user-friendly descriptions of risks, benefits, and limitations of all tests offered; clear and understandable reports of test results, with enough information to assist in decision-making; prominent instructions to contact a qualified healthcare provider with any questions or concerns; and a comprehensive, public listing of tests offered and prices charged, according to the statement.

AACC also encourages laboratory medicine professionals to collaborate with federal agencies to inform the public about the costs, benefits, interpretation, and limitations of DTC testing. Likewise, consumers should consult qualified healthcare professionals about test results and when making decisions about their healthcare.

USPSTF to Revisit Non-Traditional Cardiac Risk Factors

The U.S. Preventive Services Task Force (USPSTF) is now finaliz­ing a research plan examining the utility of high-sensitivity C-reactive protein (hs-CRP), coronary artery calcium, and ankle brachial index to assess coronary heart disease (CHD) in asymptomatic men and women. The study will compare these so-called non-traditional cardiac risk factors with the Pooled Cohort Equations and Framingham risk factors tools. Under the Affordable Care Act, insurers must cover preventive services and screening tests for which USPSTF grades the evidence A or B.

USPSTF currently grades hs-CRP and the other non-traditional factors as I, which stands for insufficient evidence, but the panel has not updated the assessment since 2009. At that time, USPSTF noted that approximately 11% of men with an intermediate CHD risk would be reclassified into the high-risk category by hs-CRP screening, and about 12% of men would be reclassified into the low-risk category, with study samples of women being too small.

On balance, however, USPSTF did not find adequate evidence that using the test could affect the occurrence of CHD events and CHD-related deaths, and noted that possible harms included lifelong use of medications without proof of benefit.