Beckman Coulter (Orange County, California) reported release of the UniCel DxH 800 Coulter Cellular Analysis System. According to the company, the system captures 29 individual measurements per cell analyzed, and provides improved sensitivity and specificity, offering more reliable assessment of abnormal cell populations. Laboratories will be able to respond more quickly and accurately to physician demands, improving patient health and reducing the cost of care, Beckman noted. The system's new design minimizes moving parts, increasing instrument reliability and technologist efficiency, the company noted. Multiple systems can be connected into a work cell to meet the volume needs of a broad range of labs. A magnetic Specimen Transport Module (STM) transports cassettes between connected instruments with no track required. Beckman said future platform enhancements include an automated slide maker/stainer, featuring the same STM technology for transporting samples. A single SMS unit will support multiple DxH 800 systems, automatically balancing the workload for connected systems and making slides based on user-defined Decision Rules, without operator intervention. Beckman develops products that simplify and automate complex biomedical tests.

InSite Vision (Almaeda, California) said that the FDA Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to recommend approval of ophthalmic suspension from Bausch & Lomb (B&L; Rochester, New York ), 0.6%, for the treatment of bacterial conjunctivitis. B&L licensed the besifloxacin DuraSite formulation from InSite Vision in 2003 following Phase 1 clinical studies and continued the development to this NDA filing. The product utilizes InSite Vision's DuraSite patented drug delivery system. DuraSite is a synthetic polymer of cross-linked polyacrylic acid that stabilizes small molecules in an aqueous matrix, allowing for targeted and sustained administration. By increasing the time that a therapeutic level of medication remains on the eye's surface, DuraSite enables a less frequent dosing schedule, increased patient compliance, and increased efficacy, the company said. InSite will receive what it termed as "competitive" single-digit royalties on sales of the approved product.

Molecular Insight Pharmaceuticals (Cambridge, Massachusetts) reported that results from a recently completed Phase II clinical study (BP-23) suggest that Zemiva, when combined with the standard of care for the diagnostic evaluation of the chest pain patient, significantly improved the detection of cardiac ischemia when compared to the standard of care alone. The improved sensitivity was more than 50% greater than the standard of care alone and was evident even in patients whose chest pain symptoms had subsided up to 30 hours prior to the Zemiva scan, the company said. Zemiva is a fatty acid analog also known as 123I-BMIPP, or Iodofiltic Acid I 123, that detects cardiac ischemia by revealing abnormalities in the fatty acid metabolism of the heart.

Ortho Clinical Diagnostics (Raritan, New Jersey) reported 510(k) clearance from the FDA for its Vitros 3600 immunodiagnostic system. According to the company, the new system delivers high-quality and dependable results by offering a comprehensive immunoassay menu based on Vitros technologies. The Vitros 3600 combines three Vitros technologies – MicroWell, MicroSensor, and Intellicheck – into a single system designed to produce highly accurate test results, Ortho said. The system will use the same reagents as other Vitros systems. The single-use tips on the system eliminate sample and reagent carryover and automatically detect clots and bubbles to avoid reporting erroneous results, according to Ortho.