• Align Technology (Santa Clara, California) said the FDA has cleared new labeling for the Invisalign system, removing the permanent dentition limitation from the indications for use. In addition, certain conditions previously listed as contraindications will now be listed as precautions. In 1998, the FDA cleared the Invisalign system for use in patients with permanent teeth and contraindicated the device for patients presenting with mixed dentition, severe overbite, severe overjet, tooth malocclusion requiring surgical correction, adolescent patients with a skeletally narrow jaw, and adult patients with dental prosthetics/ implants. The recently cleared labeling change was made based on a better understanding of the broader applications of the Invisalign system, advances in Align's manufacturing capabilities, and advances in the current practice of orthodontic treatment being administered by doctors using the Invisalign system.

• BD Diagnostics (San Diego) said it has received FDA clearance to market the BD GeneOhm Cdiff molecular assay for the rapid detection of the Toxin B gene found in toxigenic Clostridium difficile, the bacterial pathogen responsible for C. difficile infection (CDI). The GeneOhm targets the Toxin B gene, found in virtually all toxigenic C. difficile strains, including the emerging BI/NAP1/027 epidemic strain. BD claims that it is the only CDI molecular assay that combines high sensitivity and specificity and provides definitive test results in less than two hours. This new test may facilitate earlier and more appropriate antibiotic treatment of CDI patients. It may also lead to earlier implementation of infection control interventions that help prevent the transmission of the pathogen to other patients. In the U.S., an estimated 500,000 people are infected annually, and more than 28,000 die from CDI.

• Hiemstra Product Development (San Francisco) reported the introduction of hiQual, its electronic quality management system (eQMS). hiQual is Hiemstra's secure, web-based quality management system that is accessible to clients 24/7. The company says that the benefits of hiQual include increased productivity and improved communication by providing engineers immediate access to highly organized project documentation. A robust reporting engine monitors all business processes behind the scenes and provides statistical analysis for V&V. "With hiQual, Hiemstra now offers our clients a complete documentation package beginning with design and development through V&V and manufacturing," said Doug Hiemstra, president of the company.

• IntelligentMDx (Cambridge, Massachusetts) said that verification studies of the IntelligentMDx BK Viral Quantitative Assay are complete. Under the verification protocol the limit of detection, linearity, specificity and reproducibility and robustness of the BK Viral Quantitative Assay were determined. The data obtain agreed with internally generated analytical performance data generated at IntelligentMDx. The assay was shown to have a limit of detection of 8 copies of BK target per assay. The assay was linear over the 5 log range that was tested having an R-squared value is 0.99; this calculates to an amplification efficiency of 94.5%. In addition the specificity (false negative rate) for the assay was shown to be 100% for the limited number of true negatives assessed. Precision and robustness testing showed that the test was highly precise and robust with inconsequential variation observed in day-to-day and tech-to-tech testing.

• ReGen Biologics (Hackensack, New Jersey) reported that the U.S. product launch of its Menaflex collagen scaffold device will take place at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas in February. ReGen plans to highlight the Menaflex device at its AAOS booth with product demonstrations and informational activities. The company said that a U.S. consumer education website will be added to www.menaflex.com to provide information to consumers and prospective patients. The product web site is knowledge-based and is designed for those who desire to research new products and procedures on their own to supplement interaction with their surgeon.

• Tyrian Diagnostics (Sydney, Australia) said it has completed milestone four of a feasibility study in collaboration with Becton, Dickinson to determine the suitability of Tyrian's tuberculosis (TB) protein markers for the development of rapid diagnostic tests to detect active TB disease. The feasibility study demonstrated detection of selected proprietary TB proteins in sputum, along with the development of methods for sample preparation and testing suitable for use in the field. Tyrian has identified a lead marker which may be particularly suitable for a diagnostic test because it is an essential TB protein, meaning that it is always present when there is active TB.