B>• Instrumentation Laboratory (Lexington, Massachusetts), a manufacturer of in vitro diagnostic instruments, related reagents and controls, reported that it has received FDA 510(k) clearance for its HemosIL D-Dimer HS assay. This new-generation rapid, automated, latex-enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP Hemo-stasis Testing System, aids in the diagnosis of venous thromboembolism. HemosIL D-Dimer HS delivers results in less than five minutes, and offers ease of use, enhanced analytical sensitivity and working range, and minimized interferences from rheumatoid factor and hemoglobin.

• Isolagen (Exton, Pennsylvania) reported positive results of its Phase II dental study conducted by Dr. Michael McGuire to determine the safety and efficacy of the Isolagen Process for the treatment of interdental papillary insufficiency commonly referred to as “black triangles.” The analysis of the Investigator and Subject Visual Analog Scale assessment demonstrated that the Isolagen Process was statistically superior to placebo at four months after treatment, Isolagen said. The company initiated the Phase II randomized, double-blind, placebo-controlled clinical study in May 2004. McGuire, said the Isolagen Process “appears to offer the potential to grow gum tissue which is something that no other product or treatment has ever been shown to do before.” Isolagen said that based on the results, it expects to prepare protocols for Phase III pivotal trials of the product.

• Meridian Bioscience (Cincinnati) reported that Viral Antigens (VIA; Memphis, Tennessee), its wholly owned subsidiary and supplier of purified virus proteins, received a patent titled “Specificity in the detection of anti-rubella IgM antibodies” from the U.S. Patent and Trademark Office. U.S. patent No. 6,872,396 encompasses improved methods for detection of anti-rubella IgM antibodies in commercial diagnostic products, used to test blood samples for the presence of rubella antibodies. The company said that diagnostic tests using VAI’s new technology for detection of anti-rubella IgM antibodies would reduce the number of false-positive test results.

• Vertebron (Stratford, Connecticut), a manufacturer of spinal motion preservation devices and fusion technologies, reported more than 15 months of successful clinical history with the Pedicle Screw System (PSS), its first system release with more than 300 surgeries. The PSS features a threadless and low-torque locking design. As a result of its simplicity and intuitive designs which integrated advanced “leapfrog” technologies from orthopedic and spine sub-specialties, the PSS system experienced rapid adoption and penetration into spine centers as a surgeon-friendly, easy to use system, according to the company. In addition to screw angulation of up to 84 degrees and low torque locking, the PSS system is designed to use as few as five instruments for most procedures.

No Comments