A Diagnostics & Imaging Week

Diagnostic Products (Los Angeles) and Thermo Electron (Waltham, Massachusetts) reported that they have entered into an agreement for the co-development of a new, high-throughput clinical chemistry platform.

That platform will integrate with DPC's future immunochemistry platforms, and it will be suited for the medium and large-volume laboratories both in the hospital and private laboratory segments, the companies said. The combination of DPC's broad experience in immunochemistry with Thermo's clinical chemistry and automation expertise is expected to provide clinical laboratories with a comprehensive diagnostic test solution that will automate most of their routine testing needs.

"This new development agreement extends the current relationship between Thermo and DPC to a new level," said Lew Rosenblum, president of clinical diagnostics at Thermo Electron. "The existing distribution agreements, which were put in place in 2004 and cover Thermo's current clinical chemistry and automation products, have already generated excellent results in many European markets."

He added that partnering with DPC also provides Thermo with access to "the excellent distribution network that they have established throughout the world and will help ensure the global success of the new system."

Inverness Medical Innovations (Waltham, Massachusetts) said that its subsidiary, Wampole Laboratories (Princeton, New Jersey), has signed an agreement with Roche Diagnostics (Indianapolis) to collaborate on the first fully automated diagnostic test for ischemia modified albumin (IMA).

The current plan is for the albumin cobalt-binding (ACB) test for detection of IMA to be available on the Roche Cobas Integra 700 and Cobas Integra 800 chemistry analyzer systems, and Inverness is currently preparing to submit a premarket notification with the FDA for clearance.

IMA is a key marker of cardiac ischemia used in the assessment of patients with chest pain suggestive of a heart attack.

The agreement states that Wampole will sell and distribute the IMA test for Roche Diagnostics analyzers, and that they will be working with Roche Diagnostics on a co-marketing agreement for the IMA test.

The IMA assay also is available on other analyzers from Roche Diagnostics, including the Roche/Hitachi Modular Analytics Plus, the Roche/Hitachi 917, the Roche/Hitachi 911, and the Roche Cobas Mira Plus analyzers.

IMA is a serum biomarker that, when used in conjunction with echocardiogram (ECG) and cardiac troponin tests, assists in the early evaluation of acute coronary syndromes (ACS) in patients presenting to hospital emergency departments with chest pain.

In other grants/contracts news:

The National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH; both Bethesda, Maryland), said it would provide nearly $18 million for 11 High-End Instrumentation (HEI) grants that will fund the purchase of equipment designed to advance biomedical research.

Awarded to research institutions around the country, the one-time grants support the acquisition of instruments that cost more than $750,000, with a maximum of $2 million each.

Instruments in this price range include structural and functional imaging systems, macromolecular nuclear magnetic resonance spectrometers, high-resolution mass spectrometers, electron microscopes and supercomputers.

Nuclear magnetic resonance spectrometers allow researchers to determine 3-D structures of large proteins and protein complexes, while mass spectrometers provide very high resolution and accurate molecular-weight measurement for the study of large biopolymers and their interactions. Electron microscopes offer high-resolution imaging of single molecules and allow investigators to perform computer reconstruction at the subnanometer scale for large and complex macromolecular assemblies. Super computers with high-performance visualization hardware and parallel architectures allow for large data storage and high-speed transfer.

"Rapid technological development has led to a new generation of high-sensitivity, high-resolution instruments that are very expensive but that can greatly accelerate research into the underlying mechanisms of disease," said Barbara Alving, MD, acting director of NCRR. "The faster we can place these new technologies in the hands of as many NIH investigators as possible, the more rapidly we can transfer this new knowledge to patient treatments and cures."

FY05 High-End Instrumentation Grants were given to Arizona State University (Tempe, Arizona); Cold Spring Harbor Laboratory (Cold Spring Harbor, New York); Kennedy Krieger Institute (Baltimore); the University of California, San Diego; the University of Cincinnati; the University of Maryland (Baltimore); the University of North Carolina at Chapel Hill; the University of Southern California (Los Angeles); the University of Virginia (Charlottesville) and Washington University (St. Louis).

Novadaq Technologies (Toronto) and the CarboMedics unit of the Sorin Group (Milan, Italy), which focuses on medical technologies for cardiac surgery, said they have signed a North American agreement to distribute the SPY Intra-operative Imaging System, a real-time visual imaging device for use during coronary artery bypass graft surgery (CABG).

Concurrently, Novadaq and Eastman Kodak (Rochester, New York) are finalizing a U.S. service agreement to provide ongoing service and maintenance for the SPY System.

There are more than 400,000 CABG surgeries performed in North America each year. Novadaq said the SPY System is the only procedure that allows real-time visual confirmation of revascularization during CABG surgery thereby allowing bypass graft technical errors to be detected and corrected while the patient is still in the operating room.

Tm Bioscience (Toronto), which focuses on the commercial genetic testing market, said it has signed a five-year agreement to supply custom Tag-It reagents to InterGenetics (Oklahoma City) for OncoVue.

According to InterGenetics, Oncovue has been developed as the first genetic-based Breast Cancer Risk Test relevant to all women. The agreement anticipates InterGenetics will purchase a minimum of $7.5 million in reagents from Tm over the five-year period. The agreement is contingent on Tm delivering Tag-It reagents that perform according to InterGenetics' specifications.

"InterGenetics has identified and validated a large number of genetic biomarkers linked to breast cancer, and our goal was to develop a clinical test that will help women understand their personal, age-related risk of developing this disease," said Dr. Craig Shimasaki, president and CEO of InterGenetics. "With a potential market of over 30 million tests, growing at 2 million tests per year in the U.S. alone, we needed to select a production technology which was scalable for very high throughput. Our OncoVue breast cancer risk test was actually designed and developed using the Tag-It universal array platform. With state-of-the-art cGMP manufacturing facilities that can handle anticipated demand, Tm Bioscience proved to be the ideal commercialization partner for our first product."

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