IVD Technology
Magazine
IVDT Article Index
Originally Published November 2000
FDA genetic testing panel created
FDA's Center for Devices and Radiological Health (CDRH) has recently named the members of a new medical advisory committee created for genetic diagnostics. The Molecular and Genetic Testing Panel will provide advice to CDRH on the appropriate scientific criteria to use in approving diagnostic tests for human genes. The panel will also recommend classification categories for tests for human genes.
 Daniel H. Farkas, PhD |
"The selection of Dan Farkas as the industry representative was an excellent choice," says Glen Freiberg, senior director of regulatory affairs at Gen-Probe Inc. (San Diego), "as he has comprehensive experience in the science, in the hospital setting where such tests are used, and now with an innovative manufacturer."
Freiberg goes on to say, "A primary challenge of the panel will be to ensure that FDA continues to regulate products for safety and effectiveness rather than social goals and preferences of any particular administration."
Other members appointed to the panel include executive secretary Peter Maxim, PhD, Chief of the Immunology Branch in the Division of Clinical Laboratory Devices at CDRH, and panel chairperson Joann A. Boughman, PhD, vice president for research and dean of the graduate school at the University of Maryland (Baltimore).
Voting members on the panel are Arthur L. Beaudet, MD, professor and chair of the department of molecular and human genetics at Baylor College of Medicine (Houston); George C. Cunningham, MD, MP, chief of the genetic disease branch of the California Department of Health Services (Berkeley, CA); Glenn E. McGee, PhD, associate director for education at the University of Pennsylvania School of Medicine (Philadelphia); Robert F. Murray Jr., MD, chief of the division of medical genetics of the department of pediatrics and child health at Howard University's College of Medicine (Washington, DC); Walter W. Noll, MD, director of molecular genetics in the department of pathology at Dartmouth-Hitchcock Medical Center (Lebanon, NH); and Gregory J. Tsongalls, PhD, HC, director of molecular genetic pathology in the department of pathology and laboratory medicine at Hartford Hospital (Hartford, CT).
Consumers are represented on the panel by Vella K. Butcher, JD, (El Cajon, CA).—Susan Wallace
Luminex Corp. (Austin, TX) has commenced work on a project that will enable the early detection of disease by elucidating certain biochemical changes in the blood. During the initial phase of the project, researchers will screen tens of thousands of blood samples to assess the role of approximately 300 components in disease including those identified by experts as significant biochemical markers in the fields of cancer, multiple sclerosis, trauma, arthritis, diabetes, Alzheimer's disease, and heart disease. The initial screening is part of an ongoing study that is expected to grow to hundreds of thousands of samples, which will be analyzed for as many as 1000 distinct serum components. The results will be analyzed using several bioinformatic software methods. The company believes this analysis will identify protein patterns associated with various disease states. The majority of disease-related processes manifest themselves as biochemical changes in the blood. Identifying these changes is expected to permit the development of diagnostics for earlier detection of disease and to provide pharmaceutical researchers with new drug targets. The study will take full advantage of the company's proprietary LabMap technology, in which miniaturization allows large-scale proteomic arrays to be analyzed quickly in a small sample. "LabMap technology is critical to the development of this database," says Mark Chandler, chairman and CEO of Luminex. "This platform is the first to allow performing so many tests on such a small amount of blood. The database has the potential to improve medical diagnostics and should make the drug discovery process quicker and more effective. These benefits should begin to be realized early next year." |
