Originally Published IVD Technology March 2005
INDUSTRY NEWS
Notables
Biosite Inc. (San Diego) has submitted a premarket approval application to FDA for its Triage Stroke Panel, a rapid immunoassay for diagnosing stroke. According to the company, the test would be the first commercial IVD for stroke to use blood-based protein biomarkers. The Triage Stroke Panel is designed to be used with neuroimaging and can generate results in approximately 15 minutes. It detects the presence of several biomarkers and presents its analysis in the form of a single composite index.
Staking its claim in the growing Alzheimer’s disease diagnostic market, bioMérieux SA (Marcy l’Etoile, France) has acquired an option to license the technology of Applied NeuroSolutions (Vernon Hills, IL), a manufacturer of Alzheimer’s disease therapeutics and tests. Under the terms of the agreement, bioMérieux will be financially responsible for securing regulatory approvals to develop and sell diagnostic tests based on Applied Neurosolutions’ research. Including milestone payments, the licensing agreement is expected to cost bioMérieux an estimated $5 million, plus the potential cost of future royalties.
Applied NeuroSolutions, in conjunction with the Albert Einstein College of Medicine (Bronx, NY), has created a cerebrospinal fluid assay that has shown the ability to identify Alzheimer’s disease with greater than 80% sensitivity and specificity in patient tests. The company is currently working on a blood serum test that will demonstrate similar results.
The agreement represents “a strategic milestone toward our goal of evaluating best opportunities to penetrate the field of neurodegenerative diseases with innovative biological tests,” said Dr. Christophe Mérieux, senior corporate vice president of R&D and medical affairs for bioMérieux. “We will be evaluating Applied NeuroSolutions’ technology in the context of our other proprietary technologies in order to design the best solutions for Alzheimer’s disease diagnostics.”
FDA has approved the Advanced D-Dimer assay by Dade Behring (Deerfield, IL) for use in diagnosing venous thromboembolism, a condition that includes deep vein thrombosis (DVT) or pulmonary embolism (PE). The clearance includes performance data with defined cutoff values for the Dade Behring BCS system and Sysmex CA-1500 system. The assay can also be used with the company’s BCT system and Sysmex CA-7000 and CA-560 systems.
When combined with a pretest probability assessment, the assay can aid in early detection—an important treatment strategy considering that as many as 50% of patients afflicted with DVT exhibit few or no symptoms. According to the American Heart Association (Dallas), approximately 600,000 patients develop PE each year; of these, 60,000 will die from the ailment.
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