July 2009 Clinical Laboratory News: Industry Profiles

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July 2009: Volume 35, Number 7

BRNI, Inverness to Develop Alzheimer’s Test

The Blanchette Rockefeller Neurosciences Institute (BRNI) and Inverness announced that the two companies will collaborate to further develop and commercialize a diagnostic test for Alzheimer’s disease first discovered by scientists at BRNI. Under the terms of the agreement, Inverness will fund development efforts to be conducted by BRNI over an initial 3-year period. Inverness has obtained an option which, if exercised, will provide Inverness with certain rights to the technology developed for use in the diagnosis, prognosis, and monitoring of Alzheimer’s disease. “It’s still challenging to accurately diagnose Alzheimer’s disease, but I believe we are on the path to realizing a test that will take the guess work out of proper treatment,” said Daniel Alkon, MD, scientific director of BRNI. “An accurate early test will allow physicians to treat patients sooner and more effectively before symptoms intensify and the disease rapidly escalates.”

HCV Licensing Agreement Signed between Virco, Siemens

Virco BVBA signed a global research and development, non-exclusive licensing agreement with Siemens Healthcare Diagnostics, allowing Virco to develop and commercialize a new HCV research service testing platform. The platform initially will be used by pharmaceutical companies for drug development support of new HCV antivirals, but will have the potential to provide HCV clinical diagnostic testing services in the future. “With both this license and our technology platform, we are well placed to collaborate with other researchers involved in drug development in bringing diagnostic tools specific to addressing needs in the new era of antiviral combination therapries,” stated Lieven Stuyver, PhD, senior research fellow at Virco. Financial terms of the agreement were not disclosed.

Biosite Issues Voluntary Recall for Cardiac Marker Test

Biosite initiated a voluntary, nationwide recall of one lot of its Triage Cardiac Panel due to reports of low recovery of quality control samples containing creatine kinase MB (CK-MB), troponin I, and myoglobin on the affected lot. The test is used by healthcare professionals to aid in the diagnosis of myocardial infarction, but low recovery may lead to the reporting of falsely low values of CK-MB, troponin I, and myoglobin, possibly indicating the absence of a heart attack or heart muscle injury that had actually occurred. The recall is limited to the Triage Cardiac Panel, catalog no. 97000HS, Lot #W44467B, which was distributed to clinical labs in the U.S. between January and February 2009. There had been no reported issues of patient misdiagnosis associated with this lot at CLN presstime. An investigation into the cause of the recall has been initiated, and Biosite has reported the action to FDA.

Siemens, Walt Disney Team Up to Raise Awareness About Allergies

Siemens Healthcare and Walt Disney are introducing a new children’s book targeted to clinical laboratory and physician communities to educate children and parents about the diagnosis and management of allergies. Mickey and the Giant Kachoo!, featuring Disney’s Mickey Mouse, features a blood test used to identify allergens that is simpler than the traditional skin-prick test. The book was created by Siemens Healthcare and Disney as part of a corporate alliance that uses Disney storytelling to help children understand health issues. “We want parents to know there is a simple option for their children to be tested for allergic reactions,” commented David Hickey, executive vice president of Central Laboratory and Global Research Development at Siemens Healthcare Diagnostics.

Spartan Bioscience, Cooperative Diagnostics to Develop HIV Assay

Spartan Bioscience and Cooperative Diagnostics have signed a cooperation agreement to form and execute a joint research collaboration project to conduct all necessary validation testing required to join Cooperative Diagnostics’ HIV PCR Assay technology with Spartan’s DX-12 DNA analyzer. The research collaboration is intended to provide additional validation for Cooperative’s Simplex HIV-1 RNA kit in applications for infant diagnostics and viral load testing in resource-limited settings. The two companies intend to market the cost-effective and fast PCR tests to remote and underserved regions.

BD Diagnostics, HandyLab to Commercialize Molecular Assays

BD Diagnostics and HandyLab announced that they have entered into an exclusive agreement for BD to commercialize its molecular assays on the new BD MAX system, an automated molecular diagnostic testing platform in development, using HandyLab’s recently launched Jaguar instrument. The Jaguar system is the first fully-integrated, benchtop molecular diagnostic system to provide hands-off operations, including clinical sample preparation, nucleic acid extraction, and PCR amplification and detection. BD will focus initially on its BD GeneOhm line of molecular assays to detect major pathogens associated with healthcare-associated infections. “BD is a global leader in molecular diagnostic testing for infectious diseases,” stated Jeff Williams, president and CEO of HandyLab. “Together we plan to provide diagnostic laboratories with a broad molecular test menu on one of the industry’s most advanced automation platforms.

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