A Diagnostics & Imaging Week

Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina), which focuses on esoteric testing, reported "an important new relationship" that will help it expand its opportunities to offer new genomic tests by partnering with Duke University (Durham, North Carolina) to create the Duke-LabCorp Scholars in Genomic Medicine program.

The new program, led by Geoffrey Ginsburg, MD, PhD, of the Duke Institute for Genome Sciences & Policy, will support advanced research studies in specified clinical testing applications in genomic medicine which are currently being identified. The goal of the collaboration is to develop a commercial partnership that enables the translation of important genomic tests into clinical practice as rapidly as possible.

"Duke is a preeminent university, and their program in genomic medicine is one of the best in the country," said Myla Lai-Goldman, MD, executive vice president, chief scientific officer and medical director of LabCorp. "This collaboration supports our ever-growing menu of esoteric and genomic tests and underscores our commitment to work in a variety of ways with academia to bring forth new and relevant clinical tests."

The Institute for Genome Sciences & Policy (IGSP) is dedicated to the study of life through scientific inquiry involving interdisciplinary research in genome sciences and policy. It is a supporter and facilitator of campus-wide research and scholarship that explore the impact of genome sciences on all aspects of life, human health and social policy.

Areas of expertise include ethics, law and policy in genome sciences; genomic medicine; genome technology and its applications; computational genome sciences; and connecting genome sciences to society.

In other agreements:

• American Bio Medica (Kinderhook, New York), a maker of immunoassay diagnostic test kits, including "some of the world's most effective point-of-collection tests for drugs of abuse," said that it is supplying Cabela's (Sidney, Nebraska) with its point-of-collection drug screening kits. The drug screens will be used at Cabela's retail outlets for pre-employment and random drug screening of its employees.

Cabela's currently has 14 retail locations across the U.S. and has recently reported that in 2007 and 2008 it plans to open stores in another 13 locations.

• Advanced BioPhotonics (Bohemia, New York), a developer of medical imaging applications using advanced infrared technology, said that it has entered into an agreement with the Dartmouth-Hitchcock Medical Center and Dartmouth Medical School Department of Surgery (both Hanover, New Jersey).

Dartmouth will participate in the company's multicenter clinical trial investigating the use of Advanced BioPhotonics' DIRI method of dynamic infrared imaging in mapping vascular perforator blood vessels in plastic and reconstructive surgery procedures.

• LGC (Teddington, UK), an independent analytical laboratory, and Gentris (Research Triangle Park, North Carolina), a global provider of applied clinical pharmacogenomic services and diagnostic product solutions, reported that the companies have entered into a non-exclusive licensing agreement.

Gentris obtains rights to make, use and sell diagnostic products and services which include testing for the CYP2D6*4 polymorphism in the U.S. LGC is the exclusive licensor of this gene variation on behalf of the University of Dundee (Dundee, Scotland) and Cancer Research UK.

Patients with the *4 variant of the CYP2D6 gene are known to be poor metabolizers of about 20% of commonly prescribed medications including painkillers, anti-depressants, analgesics and cardiovascular drugs.

The commercialization and adoption of CYP2D6 genetic testing services and diagnostic products is expected to contribute to reducing adverse drug reactions (ADRs) in this population and improving the quality and efficacy of drugs and ultimately patient care. Currently ADRs account for 106,000 deaths per year and 2.2 million hospitalizations per year in the U.S., making them the fourth leading cause of death and fifth leading cause of illness.

The announcement coincides with the recent release of Gentris' human genomic DNA reference controls for the CYP2D6 gene, which are currently available for research use. No other commercial source of reference controls for the CYP2D6 gene is presently on the market, Gentris said.

• Sphere Medical (Cambridge, UK/Oudenaarde, Belgium), a developer of next-generation critical care patient monitoring systems, said it has selected AMI Semiconductor (Pocatello, Idaho), a maker of mixed-signal and structured digital products for the medical and industrial sectors, to design and fabricate a sensor interface ASIC for Sphere's continuous arterial blood gas monitor, in development.

The Sphere real-time blood gas monitoring solution includes a disposable sensor and AMIS sensor interface ASIC, enclosed in a standard IV tubing set. The blood gas measurements are output to a small bedside monitor. This continuous monitoring approach offers advantages over central lab console analyzers and portable cartridge-based analyzers by making treatment decision-making faster and therapies managed more effectively, Sphere said.

The sensor interface ASIC solution includes a high-performance analog subsection with an ultra-low power analog-to-digital converter, temperature sensor, power management, and a communications interface.

Peter Laitenberger, vice president of R&D at Sphere, said, "It's clear that the technical requirements of our sensor interface ASIC will push the boundaries of state-of-the-art signal acquisition and conditioning for physiologic monitoring systems. After a thorough evaluation of the leading circuit designers and foundry suppliers in the medical device market, AMIS demonstrated significant advantages in IP, process longevity, medical design focus and expertise, in addition to a first class system architecture consulting process."

"Sphere's continuous blood gas monitoring technology has the potential to enable dramatic improvement in the quality of critical care medicine," said Todd Schneider, vice president of the medical group at AMIS.

AMIS has a network of sales and design centers in North America, Europe and the Asia Pacific region. It serves the device market through a medical and wireless product line group headquartered in Waterloo, Ontario.