By Kirell Lakhman

The Agency for Healthcare Research and Quality's Technology Assessment Program has released a detailed report of the kinds of molecular diagnostics currently prescribed to Medicare recipients, and the challenges clinical labs face when using the tests.

The report, which seeks public comments, studied pharmacogenomic tests used to diagnose symptomatic individuals; to help make prognoses; to monitor drug response; and to choose therapies or to help physicians adjust dosing.

Titled "Quality, Regulation and Clinical Utility of Laboratory-Developed Tests," the behemoth of a report can be found here.

According to TAP, the assessment relied on more than 1,400 molecular tests “relevant to the Medicare over-65-year-old population” offered by 95 different labs.

Some of the questions it sought to answer are: “How is analytic validity established for laboratory-developed molecular tests; What processes have been developed for examining clinical validity and clinical utility of molecular tests; How are molecular tests regulated by CLIA; What FDA guidance has been issued pertaining to oversight of laboratory-developed molecular testing; What is the role of other Federal agencies (e.g., Federal Trade Commission) in regulating marketing claims regarding the clinical validity and utility of laboratory-developed tests not currently being actively regulated by the FDA; How is proficiency testing accomplished for molecular tests, whether laboratory-developed or commercial; and What guidelines and standards exist for laboratories conducting molecular testing.

The report — which incorrectly called FDA the Federal Drug Administration — concludes that “given the dynamic nature of the molecular testing area, the assessments of the quality, regulation, or utility of LDMTs need to be frequently updated. One of the major challenges for those making decisions about the oversight of [lab-developed molecular tests] will be to keep pace with the future developments in the area.

The report also says “the experience of the Clinical Laboratory Evaluation Program in New York State” can “certainly provide some valuable lessons in how the oversight of LDMTs might be accomplished and what resources would be necessary to do so on a national scale.”

“At this stage in the evolution of laboratory-developed tests, assessments of the appropriate clinical applications and evidence-based guidelines for using test results in decision making are only beginning to appear," the assessment says. “The Evaluation of Genomic Applications in Practice and Prevention program is making important contributions in this area, but with the rapid expansion of test offerings, guidance for the use of most laboratory-developed tests will lag far behind.”

The assessment also concludes that “in the absence of specific reimbursement codes for specific laboratory-developed and other molecular tests, it will be difficult to track practice patterns and to understand the impact of these tests on the patient outcomes and on the practice of medicine.”

TAP reports, which are performed at the request of CMS’ Coverage and Analysis Group, can shape national coverage policies. The current assessment is also noteworthy because Medicare, the biggest purchaser of clinical lab services in the US, paid $7.1 billion for lab tests in 2008. These costs rose an average of 9 percent between 1999 and 2006.

Because of these factors, the TAP authors are seeking pubic review and comment. The period for this review ends Sept. 1.