College of American Pathologists
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CAP genetic testing oversight efforts

FDA puts ASR rule back on the table

October 2003
Karen Lusky

The College continues to chart a proactive course to address quality concerns for genetic testing. The conceptual framework for this effort consists of three primary components:

  1. Review of laboratory-developed test validation.
  2. Inspection by inspectors with genetic testing experience.
  3. Availability of proficiency testing programs for genetictests.

“The CAP’s first goal was to provide a mechanism within the inspection process for the review of genetic tests developed by the laboratory without the use of FDA-approved test kits,” said Debra Leonard, MD, PhD, in testimony at the Sept. 18 meeting of the Clinical Laboratory Improvement Advisory Committee. Dr. Leonard is chair of the College’s Molecular Test Validation Project Work Group and director of the molecular pathology laboratory and associate professor of pathology at the University of Pennsylvania Health System, Philadelphia.

A new section of the molecular pathology laboratory inspection checklist has been drafted to address genetic test validation. The draft includes 10 new checklist questions and commentaries, which address analytical and clinical validity and appropriate reporting. “Specifically, the clinical validity of the test can be documented through either literature citations or internal studies,” Dr. Leonard told CLIAC members.

The new questions will apply to all laboratory-developed molecular tests introduced since the last inspection. The new checklist questions are under consideration by the CAP Commission on Laboratory Accreditation, and they are expected to be approved and incorporated into the molecular pathology checklist by the end of 2003.

The CAPhas a growing list of qualified inspectors for specialty areas, including cytogenetics, biochemical and molecular genetics, and molecular pathology. The Collegeis requesting information about experience in these areas and cosponsoring inspector-training sessions with the American College of Medical Genetics and the Association for Molecular Pathology. And, in the area of proficiency testing, it is working to enhance its existing programs for genetic tests.

Karen Lusky is a writer in Brentwood, Tenn.