April 6, 2006

The Centers for Medicare & Medicaid Services (CMS) is dragging its feet in providing the necessary oversight to ensure laboratory genetic tests are valid, performed correctly and explained properly to patients, according to an advocacy group that says the tests are needed to realize the potential of personalized medicine.

The CMS has authority under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to oversee these tests, advocates from the Genetics & Public Policy Center (GPPC) said April 4. But while the Centers for Disease Control and Prevention (CDC) in 2000 issued a Notice of Intent indicating the CMS would issue a proposed rule on standards for the tests, CMS has yet to fulfill its pledge, the GPPC said.

The GPPC is concerned about how long it has taken for the CMS to develop the rule and is seeking a more concrete timeline, Gail Javitt, the organization's director of law and policy, told FDAnews.

The group wants the CMS to implement rules under CLIA that require laboratories to have sufficient quality control and personnel standards in place before conducting the tests. Premarket approval is also needed to confirm the tests are valid and reliable in detecting genes related to disease or disease risk, the GPPC said. Labs must also take steps to ensure that healthcare providers understand when to order the tests, how to interpret them and what to do with the results, the group added.

The CMS has agreed to take some steps in the coming months. "We intend to publish a Notice of Proposed Rule Making for genetic testing as quickly as is feasible," said Thomas Hamilton, director of the CMS' Survey and Certification Group, in a Jan. 9 letter to GPPC. "We are quickly working with staff at the [CMS] to this end and we expect to publish in the coming months."

Meanwhile, the FDA has made developing personalized medicines, which are tailored to a patient's genetic makeup, a priority under its new Critical Path Initiative. Industry groups have formed consortia to promote the development of these therapies, which drugmakers believe can result in more effective treatments and more efficient drug development.

But the GPPC contends that the CMS' failure to provide guidance is hindering that effort. There is no formal approval procedure a lab must follow before offering a new molecular or biochemical genetic test, the group said. There are also no government requirements that a test must be clinically valid -- that is, actually relating to a particular disease or risk of disease -- in order to be sold, the group added.

These "gaps in the regulatory system" leave patients and their doctors without assurances that labs are performing tests properly or will provide information relevant to clinical decisionmaking, the GPPC argued.