• Hologic (Bedford, Massachusetts) reported the results of the Cervista HPV high-risk pivotal clinical trial. The Cervista HPV high-risk test is currently under review by the FDA in the U.S. and is expected to be launched in the European Union early in 2009. The Cervista HPV high-risk test is designed to detect the 14 high-risk types of HPV that cause cancer. The proposed intended use of the test is as a general screen, in combination with cervical cytology (Pap test), to help guide patient management for women 30 years of age or older, and as a triage for ASC-US cytology results to determine the need for referral to colposcopy. The results of the study were as follows: 100% CIN3 detection and a corresponding negative predictive value of 100%. Patients with CIN3 are at the highest risk of developing cervical cancer. The sensitivity of the test for CIN2+ was 92.8%, with a corresponding negative predictive value of 99.1%. Patients with CIN2 are at risk of developing cervical cancer; however, this risk is not as high as it is for those diagnosed with CIN3.

• Innocoll (Ashburn, Virginia) said that the FDA has designated Gentamicin Surgical Implant as a fast-track development program. Gentamicin is being evaluated in two Phase III clinical trials as an adjunct to systemic antibiotic administration for the prevention of surgical site infections in patients who are at higher risk of developing surgical site infections. The Gentamicin implant is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localized action, while maintaining low systemic levels well below the toxicity threshold.

• Luminex (Austin, Texas) reported the commercial sale and shipment of the first Flexmap 3-D system manufactured in Austin. Full market release of the instrument is expected in 1Q09. The company says that the Flexmap 3-D system uses its flexible xMAP technology, which is built on the existing, proven technology of flow cytometry, microspheres, lasers, digital signal processing and traditional chemistry. xMAP technology provides both protein and nucleic acid applications on one platform, and has allowed Luminex to expand its reach into market segments such as life science research, molecular diagnostics, HLA testing, and markets as diverse as biodefense, animal health and agro-biotech.

• Wound Care Innovations (Fort Worth, Texas) reported FDA clearance of a new wound management product utilizing its patented hydrolyzed collagen technology. This product line combines hydrolyzed collagen with the healing properties of polysulfated glycosaminoglycan (PSGAG) and will initially be available in gel form. PSGAG enhances the absorptive capacity of the hydrolyzed collagen gel, making it appropriate for the management of exudative wounds. In addition, PSGAG has been shown to prepare the granulation tissue for epidermal migration by maintaining a uniform, low-density granulation tissue more easily modified by the migrating epithelium thus improving the rate of epithelialization of a chronic wound and reducing scarring.