• Cepheid (Sunnyvale, California) has received FDA 510(k) clearance to market its Smart GBS test for Group B Streptococcus (GBS) on its SmartCycler platform. Smart GBS is intended for rapid detection of GBS colonization in pregnant women. The system is designed as a PCR testing platform for hospitals, university research labs and government agencies. Cepheid is a molecular diagnostics company that creates systems for genetic analysis in the clinical, industrial and biothreat markets.

• EP MedSystems (West Berlin, New Jersey) reported the launch of its MapMate Interface link between its EP-WorkMate Recording System and CARTO XP Navigation and Ablation System. The CARTO XP System, from Biosense Webster, is a 3-D navigation system used in advanced ablation procedures for treatment of patients with irregular heartbeats. The MapMate interface was recently cleared by the FDA. The MapMate Interface between EP-WorkMate and Carto XP System was designed to simplify procedures by having the recording system and the 3-D navigation system communicate with each other to combine diagnostic data from each system and eliminate duplicate demographic data entry. Currently most labs must separately enter and manage patient data on their individual recording and navigation systems. By linking the detailed electrograms from sites within the heart to the "roadmap" used in conducting ablation procedures, MapMate Interface allows clinicians to rapidly see complete information to conduct the proper course of treatment, and produce comprehensive case reports from the EP-WorkMate Recording System. EP MedSystems develops cardiac electrophysiology products used in imaging, diagnosing and treating certain cardiac rhythm disorders

• Fluidigm (South San Francisco) has launched the second in a line of nano-fluidic chips — digital arrays — run on its BioMark system for qPCR analysis. Digital arrays have applications that require absolute counting of target molecules, often within samples as small as a single cell. The method of choice to achieve such quantification is known as digital PCR, generally impractical for routine use. Digital PCR works on the principle that target sequences may be counted if a sample is diluted such that only one copy of the target may be present in a well after the sample is distributed to all wells on a microwell plate. Digital arrays have made the process of limiting dilutions easy and reliable because a sample/assay mixture is loaded into a single well and automatically dispersed into about a 1,000 nanovolume reaction chambers, Fluidigm said. Fluidigm develops systems based on the properties of integrated fluidic circuits (IFCs) to precisely control fluids on a nanovolume scale.

• Medicsight (London) reported the publication in the December 2006 issue of Gastroenterology of a study that showed Medicsight CAD (computer-aided detection) significantly improved reader interpretation of CT colonography. The study investigated the effect of CAD assistance on the performance of 10 readers who were 'non-expert' in the interpretation of CT colonography. Each participant read 107 CT colonography cases: 60 patients had 142 polyps and the remaining 47 had normal colons. The cases were first read without the assistance of CAD and then two months later the studies were read with the assistance of CAD. The study found that readers detected significantly more polyps with CAD than without. Medicsight plc, a subsidiary of Medicsight, is an investment company that focuses solely on the dynamic and consolidating HCIT sector.

• Tm Bioscience (Toronto) reported results from clinical testing of the ID-Tag RVP regarding the H5 subtype of the influenza A virus, the focus of the current pandemic threat being monitored through the World Health Organization (Geneva). Results confirm the ability of the ID-Tag RVP to detect the bird flu virus in all positive clinical samples tested (0% false-negative rate for H5). Additionally, the majority of patient samples tested by the ID-Tag RVP across both the European and North American arms of the clinical trial were probed for Influenza A-H5. There were no false-positive results observed in any of these samples. The ID-Tag RVP is a test that, in a single patient sample, simultaneously probes up to 20 distinct viral sequences that represent more than 95 percent of all circulating respiratory viruses. The ID-Tag RVP has been designed to enable, through a single test on a patient sample, discrimination of the H5 subtype of influenza A from the subtypes generally seen in the human population (H1, and H3). It also discriminates influenza A from a panel of respiratory viruses, including those with similar clinical presentations. Tm Bioscience develops DNA-based tests for genetic disorders, drug metabolism and infectious diseases.

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