INDUSTRY NEWS
FDA’s Center for Devices and Radiological Health (CDRH) has issued a draft guidance on preparing and reviewing approval applications for pharmacogenetic tests. The February 9 document, “Pharmacogenetic Tests and Genetic Tests for Heritable Markers,” is aimed ostensibly at shortening development and review times and encouraging the “rapid transfer of new technology from the research bench to the clinical diagnostic laboratory.” The guidance reviews design considerations, as well as the submission of descriptions of analytical and clinical studies carried out during the development process. Also included are suggestions for planning and evaluating clinical studies. The document replaces a 2003 draft guidance: “Multiplex Tests for Heritable DNA Markers, Mutations, and Expression Patterns.”
Comments and suggestions regarding the draft document will be accepted for 90 days following its publication in the Federal Register. Copies of the guidance can be accessed through CDRH’s Web site at www.fda.gov/cdrh/oivd/guidance/1549.pdf.
Researchers at Northwestern University (Evanston, IL) have used a nanosensor to detect amyloid-derived diffusible ligands (ADDLs), tiny proteins suspected of playing a leading role in Alzheimer’s disease. ADDLs are present at levels up to 70 times greater in autopsied brain samples from patients with Alzheimer’s than from those without. The sensor, which incorporates a UV/VIS spectrometer from Ocean Optics Inc. (Dunedin, FL), is based on tiny, triangular silver particles that absorb and scatter light. A layer of ADDL-specific antibodies is applied to the nanoparticle surfaces. When they bind to ADDL molecules in a sample, the spectral properties of the silver particles shift.
Nanogen Inc. (San Diego) has purchased the rapid cardiac immunoassay test business of Spectral Diagnostics Inc. (Toronto) for nearly $8 million. As part of the deal, Nanogen will acquire the Cardiac STATus and Decision Point product lines, the I-Lynx reader, as well as related intellectual property and manufacturing capabilities. “This acquisition provides Nanogen a solid position in the cardiovascular point-of-care market in advance of our congestive heart-failure test receiving regulatory clearance,” said Howard C. Birndorf, chairman and CEO of Nanogen. In addition, approximately 50 of Spectral’s employees have joined Nanogen’s point-of-care group in Toronto.
Spectral will retain intellectual property and revenues related to its troponin I calibrator, as well as other reagents. “Spectral will now have the opportunity to focus on its key growth areas in sepsis and infectious disease,” said Paul Walker, MD, PhD, CEO of Spectral. “We will have sustainability through our royalty and reagent revenues, and growth both from our existing products and from other potential opportunities facilitated by our strengthened balance sheet.”
Bayer Diagnostics (Tarrytown, NY) has licensed patents relating to free prostate-specific antigen (fPSA) and tacrolimus tests from Abbott (Abbott Park, IL). Bayer says it intends to develop the two tests for its Advia Centaur and Advia Centaur CP immunoassay systems. Current assays for the Centaur system include those for cancer, cardiovascular diseases, fertility, anemia, thyroid diseases, allergy, metabolic diseases, and therapeutic drug monitoring. “This is another example of Bayer HealthCare Diagnostics’ commitment to expanding the test offering for immunosuppression drugs,” said Tom Warekois, senior vice president of global strategic marketing at Bayer Diagnostics. “Tacrolimus is complementary to cyclosporine, which is currently also in development and scheduled to release in 2006.”
Lou Dunka, PhD, former industry division chair of the American Association for Clinical Chemistry (AACC), passed away on February 17. At the time of his death, Dunka was principal scientist at LifeScan Inc. (Milpitas, CA), where he worked for 14 years. During his more than 30 years in the IVD industry, he played an active role in shaping point-of-care-testing (POCT) standards. Dunka’s first POC experience came at Instrumentation Laboratory (Lexington, MA), where he served as senior research and development manager. From there, he moved to Life-Scan as manager of quality assurance development before becoming principal scientist.
Dunka founded and chaired the area committee for POCT at the Clinical Laboratory and Standards Institute (formerly NCCLS; Wayne, PA) and guided the Connectivity Industry Consortium, which developed a universal connectivity standard for POCT. He was also a member of the U.S. technical advisory group to the International Organization for Standardization’s Technical Committee 212 (ISO TC 212) as well as TC 212’s working group 3.
