Government Advisory Committee Recommends New Genetic Testing Laboratory Practices, USA

Main Category: Genetics
Article Date: 28 Oct 2008 - 3:00 PDT

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On September 10-11 the Clinical Laboratory Improvement Advisory Committee (CLIAC) met at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia to review the result s of a working group CDC assembled to develop good laboratory practices for molecular genetic testing. The workgroup presented to CLIAC a summary document that encompasses all phases of testing, as well as guidelines on confidentiality, record retention, and personnel requirements. The CLIAC workgroup limited the scope of the document to molecular-based testing for heritable disorders or conditions, which includes pharmacogenetic applications but excludes somatic genetic testing, cytogenetic testing, and biochemical genetic testing.

Since CLIA regulations do not have special requirements for genetic testing, these guidelines attempt to bridge the gap by establishing laboratory practices tailored to molecular genetic testing. If CLIA and other accrediting bodies adopt these recommended guidelines as requirements for accreditation, then the guidelines would be more stringent than current CLIA regulations, but less stringent than guidelines established by the New York State Clinical Laboratory Evaluation Program and the College of American Pathologists accreditation requirements.

CLIAC intends to form a working group to develop similar guidelines for biochemical genetic testing.

The guidelines are expected to be published in November 2008 in the Morbidity and Mortality Weekly Report. Since the guidelines are not regulations, there will be no official public comment period; rather, the CDC will monitor public comments and amend the guidelines over time.

Written by Sara Katsanis

The Genetics and Public Policy Center at Johns Hopkins University

The tremendous success of the Human Genome Project has laid the foundation for a true revolution in public health, promising improved diagnosis, more effective medicines, and individually tailored health care. The Genetics and Public Policy Center was created in 2002 at Johns Hopkins University by Pew Charitable Trusts to help policymakers, the press, and the public understand and respond to the challenges and opportunities of genetic medicine and its potential to transform global public health.

http://www.dnapolicy.org