A Medical Device Daily
Asuragen (Austin, Texas), a molecular biology diagnostic company, said it has agreed to develop and manufacture RNA Control Kits for Affymetrix (Santa Clara, California). The kit is intended for use with in vitro transcription reagent kits for clinical molecular diagnostic applications that Asuragen has licensed and supplied to Affymetrix.
The kits will enable Affymetrix to deliver a complete solution to its molecular diagnostic partners, Asuragen said. The products will be configured for use with the GeneChip System 3000Dx v.2. This is the only available diagnostic microarray platform that has FDA 510(k) clearance and the CE mark, according to Asuragen.
"Affymetrix offers a continuous path to discover, develop, and commercialize biomarker signature assays," said Matt Winkler, CEO and chief scientific officer of Asuragen.
Affymetrix is partnering with diagnostic companies through the Powered by Affymetrix (PbA) Program to bring to market new diagnostic tests that employ the latest genomic discoveries. There are currently more than 20 different molecular assay tests based on the Affymetrix platform under development by Affymetrix and its 11 PbA Partners. The resulting microarray-based tests will enable clinicians to provide more efficient and complete methods to diagnose, classify, and manage patients suffering from complex diseases like cancer, the company said.
In other agreements/contracts news:
• Quick-Med Technologies (Gainesville, Florida) said that its licensee, Derma Sciences (Princeton, New Jersey), has entered into an exclusive distribution agreement with Medline Industries (Mundelein, Illinois) whereby Medline will market and sell Bioguard wound dressings with Quick-Med's Nimbus antimicrobial technology. The agreement covers the acute care segment of the healthcare market, which includes nearly 6,000 hospitals in the U.S. plus surgery centers, wound care centers, and other associated healthcare facilities. Sales under this new agreement are expected to start later this month.
The new arrangement with Medline is expected to take account of the newly expanded range of wound dressing product formats included in Quick-Med's recent amendment to Derma Sciences' Nimbus license. According to Derma Sciences, Bioguard will be a key new product introduction in 2010 for Medline, adding to Medline's list of wound care products in the U.S.
According to the company, Nimbus is the first non-leaching antimicrobial available in a wound dressing. It received FDA clearance in February 2009 and Derma Sciences introduced its Biogaurd dressings in June.
• Insight Imaging (Lake Forest, California) said it reached a three-year agreement to provide insight Imaging Enterprise Solutions to the Progressive Imaging Center on the campus of Clara Maass Medical Center in Belleville, New Jersey, an affiliate of the Saint Barnabas Health Care System, New Jersey's largest not-for-profit integrated healthcare delivery system.
• R-Squared (Princeton, New Jersey) reported a strategic alliance with IMS Health (Norwalk, Connecticut) to help pharmaceutical and medical device manufacturers comply with the growing body of state transparency and marketing disclosure laws, known as "aggregate spend" reporting laws. As part of the alliance, R-Squared's SpendTracker compliance application platform will be deployed to support IMS's new Aggregate Spend Compliance Services.