The subject of "Federal Neglect: Regulation of Genetic Testing Genetic Testing Definition
A genetic test examines the genetic information contained inside a person's cells, called DNA, to determine if that person has or will develop a certain disease or could pass a disease to his or her offspring. ," 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 diagnostic services,
n.pl the imaging and laboratory capabilities available for determining the cause of an illness. . 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 a·larm·ist
A person who needlessly alarms or attempts to alarm others, as by inventing or spreading false or exaggerated rumors of impending danger or catastrophe. 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 Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. of 1988 (CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a ). 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 David, in the Bible
David, d. c.970 B.C., king of ancient Israel (c.1010–970 B.C.), successor of Saul. The Book of First Samuel introduces him as the youngest of eight sons who is anointed king by Samuel to replace Saul, who had been deemed a failure. A. MONGILLO
Vice President for Policy and Medical Affairs
American Clinical Laboratory Association