Genetic testing.

The subject of "Federal Neglect: Regulation of Genetic Testing," by Gail H. Javitt and Kathy Hudson (Issues, Spring 2006) is clearly an important one as advances in genetics and genomics contribute to the development of new genetic tests and services, driven by physician and patient demand for these diagnostic services. The number of genetic tests available is rising as the technology develops, as is the significant contribution that these tests make to individualized personal health care. Genetic tests can detect disease early, before the onset of symptoms, when treatment can be more effective; and can specifically target therapy for existing disease that is more effective for the individual patient. It must be the shared objective of all of us to ensure that patients obtain the full benefit of this revolutionary technology, to continue to encourage innovation, and to regulate in ways that are appropriate and do not create barriers to either patient access or innovation.

I must take exception to the article's alarmist premise that federal "neglect" in the oversight of genetic tests "represents a real threat to public health." In fact, the regulatory gap referred to by the author is illusory. The clinical laboratory industry is one of the most highly regulated health care-delivery sectors. All clinical lab services are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLIA regulations are documented by hundreds of pages of specific and general requirements for laboratory quality, such as obligations to have appropriately trained personnel, establish quality-control programs, and engage in proficiency testing, which all apply to laboratories performing genetic testing. More important, CLIA regulations require that before a laboratory introduces a new method or test that does not use a commercially available test kit, it must establish and document the performance specifications for accuracy, precision, analytical sensitivity, analytical specificity, and quality of results for patient care: all essential parameters of quality and performance. These requirements are enforced by onsite inspections every two years. The penalties for noncompliance are severe and can lead to the revocation of the lab's CLIA certificate, without which a lab is unable to provide services.

The record indicates that laboratory tests are accurate and reliable and provide information relevant to the patient and his or her doctor. It is important that any proposed regulatory changes focus on risks specifically related to genetic tests and those that are targeted, realistic, and effective to meet any legitimate issues or risks. It is incumbent on all of us to work together to identify specific concerns and regulatory responses that will address those concerns without creating undue burdens that will stifle innovation or restrict patient access to new technology.

DAVID A. MONGILLO

Vice President for Policy and Medical Affairs

American Clinical Laboratory Association

Washington, DC

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