• AdvanDx (Woburn, Massachusetts) said it received FDA clearance of the Yeast Traffic Light PNA FISH to identify Candida yeast species directly from positive blood cultures. The Yeast Traffic Light is the latest addition to AdvanDx's molecular-based PNA FISH diagnostics platform that provides identification of bloodstream pathogens. Candidemia, a bloodstream infection caused by Candida species is one of the most serious hospital acquired infections, afflicting over 24,000 patients in the U.S. every year. AdvanDx makes molecular diagnostic products for the prevention, diagnosis and treatment of life-threatening, bacterial infections.

• BioImagene (Cupertino, California) has introduced the newest edition of the iScan slide scanner with version 2.0. The iScan is BioImagene's desktop slide-scanning system for digital pathology. It allows batch scanning up to 160 slides, freeing up the histotechnologist's time to complete other tasks. The new iScan produces images with excellent resolution at faster scan times of three minutes a slide. A session management module has been added to allow users to save and restore scanning sessions, and allows recovery of the last scanning state in the event of a power blackout. Enhanced feedback and status messages, provides the users with time estimates for scanning batches, for better time management and efficiency.

• Guided Therapeutics (GT; Norcross, Georgia) reported completion of its FDA trial for its LightTouch non-invasive cervical cancer detection device. The GT LightTouch technology systematically scans the cervix to identify cancers and pre-cancers painlessly and non-invasively by analyzing the wavelengths of light reflected from cervical tissue. The LightTouch uses technology to identify cancers and pre-cancers painlessly and non-invasively by analyzing light reflected from the cervix. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the non-invasive test does not require a tissue sample or laboratory analysis, and results are available immediately.

• Lucid (Rochester, New York) said that it has received FDA clearance to market its VivaScope system. VivaScope confocal imagers provide noninvasive, in vivo cellular resolution images of skin and are now specifically cleared ". . . for review by physicians to assist in forming a clinical judgment." A VivaScope system may consist of a VivaScope 1500 confocal imaging head, a VivaScope 3000 imaging head, or both. The VivaScope 1500 is Lucid's second-generation in vivo confocal imager, designed for routine clinical examination of the skin. The VivaScope 3000 is a handheld confocal imager, and can more easily access those areas of the skin that may be difficult to image with the 1500.

• Pioneer Surgical Technology (Marquette, Michigan) reported the market release of the Cross-Fuse lateral option system. The Cross-Fuse is Pioneer's latest addition to a comprehensive family of PEEK (poly-ether-ether-ketone) VBRs. "The entire Cross-Fuse system, from implants to instrumentation, is well thought out," said Thomas Highland, MD, of the Columbia Orthopaedic Group, Columbia, Missouri. Highland says, "The innovative design of the trial spacers and other instruments are very user-friendly, and the PEEK material in the Cross-Fuse implants causes no artifact in MRI or CT imaging."

• Monogram Biosciences (South San Francisco, California) said that it has initiated a study, in collaboration with the Dana-Farber Cancer Institute (Boston), to evaluate Monogram's HERmark breast cancer assay in metastatic breast cancer. In the study, the HERmark assay will be used to analyze about 600 tissue samples from patients with breast cancer, roughly half of whom were eligible for treatment with Herceptin on the basis of prior HER2 IHC and/or FISH testing. HERmark measurements of HER2 total protein and HER2 homodimer levels will be compared with the results of IHC and/or FISH testing as well as response to treatment with Herceptin.

• Qiagen (Venlo, the Netherlands) has introduced a new HPV test specifically for use in regions of the world with scarce resources that it said is "substantially" more accurate in identifying women with cervical disease than the current methods (Pap testing and visual inspection) in these countries. The new test for HPV (human papillomavirus), the primary cause of cervical cancer, is being developed by in partnership with PATH. The careHPV test is specially designed to allow women in areas with scarce healthcare resources to benefit from the advanced technology of HPV testing: It produces rapid, accurate results, yet is also simple to run, requires minimal infrastructure and will be affordable for public-health programs in these countries.

• SQI Diagnostics (Toronto) reported positive results from its external validation tests conducted at the Cleveland Clinic and Mount Sinai Hospital in Toronto. The results demonstrated that SQI's automated SQiDworks platform and QuantiSpot RA microarray consumable test performed consistently at all sites, at a level that is equivalent to the performance of FDA-approved manual diagnostic devices, while offering significantly greater efficiencies in costs and labor. The SQiDworks automated platform is used to analyze multiple-biomarkers in a fully automated "load-and-go" process. The lead test for the platform is the QuantiSpot RA assay, which provides simultaneous analysis of four biomarkers commonly prescribed to aid in the diagnosis and monitoring of rheumatoid arthritis, including the anti-CCP-IgG marker that has been adopted rapidly over the last five years.