BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey), through its BD Diagnostics business, reported that the FDA has cleared the BBL CHROMagar MRSA product. The new prepared plated medium simplifies the process, decreases the time to result and offers high sensitivity and specificity for methicillin-resistant Staphylococcus aureus (MRSA) identification. BBL CHROMagar MRSA allows microbiology laboratories to identify patients colonized with MRSA more quickly and easily than the processes currently available, within 24 hours. BBL CHROMagar MRSA uses a new chromogenic technology that permits the detection of MRSA using chromogenic substrates and a cephalosporin. MRSA strains will grow in the presence of antibiotics and produce mauve-colored colonies resulting from hydrolysis of the chromogenic substrates.
Bio-Rad Laboratories (Hercules, California) reported that it has received FDA clearance for its BioPlex 2200 system, a new immunoassay platform that uses multiplexing technology to analyze for multiple disease states from single patient samples. It is the first clinical diagnostics platform to offer multiplexing technology on a fully automated, fully integrated random access platform, according to the company. Bio-Rad said the system would soon be available in the U.S.
Dade Behring (Deerfield, Illinois) reported FDA clearance for the use of its Advanced D-Dimer assay as an aid in the diagnosis of venous thromboembolism (deep vein thrombosis or pulmonary embolism). The clearance included performance data with a defined cutoff value for the Dade Behring BCS System and Sysmex CA-1500 System. The assay is also for use on Dade Behring's BCT System, and Sysmex CA-7000 and CA-560 Systems.
Diopsys (Pine Brook, New Jersey) said clinical results of its new pediatric vision test, the Enfant Pediatric Vision Testing System, show a 97% sensitivity in detecting vision deficits in children as young as six months of age, according to a study published in the December 2004 issue of the Journal of the American Association for Pediatric Ophthalmology and Strabismus. The Enfant, a non-invasive, child-friendly, device that tests for visual deficits using visual evoked potential technology, records the brain's response to light and can detect vision problems early in a child's life when these conditions are correctable.
Imalux (Cleveland) reported that its Niris Imaging System, based on optical coherence tomography (OCT) technology, received FDA clearance. Imalux said it would begin broad-based marketing and sales efforts for the system in 1Q05. The company received initial clearance from the FDA last March to market the Imalux OCT Imaging System. Since then, it has received two additional FDA clearances, one for an accessory sheath for the imaging system probe, designed to provide a microbial barrier and aid in positioning the probe. The second, and most recent, cleared the Niris Imaging System for commercialization. Enhancements to the initial Imalux OCT Imaging System now available as Niris include the interchangeability of different probe lengths and an improved software interface. OCT uses low-power, near-infrared light to create high-quality, real-time medical images.