Originally Published IVD Technology April 2002
Notable
Igen International Inc. (Gaithersburg, MD) was awarded $505 million in damages in a case against Roche Diagnostics GmbH (Basel, Switzerland). Presented before the U.S. District Court of Maryland, the verdict allows Igen to terminate a license agreement that had permitted Roche to use Igen's Origen biological detection technology in its products. The ruling, which must be affirmed by the court of appeals, also gives Igen the rights to Roche's Elecsys product line of immunoassay analyzers and the tests developed for use on the systems. The license termination won't go into effect unless the judgment is affirmed by the court of appeals, which can take up to 18 months.
"This judgment
confirms the recent jury verdict and properly awards to Igen the relief that
we have been seeking over many years," said Samuel J. Wohlstadter, chairman
and CEO of the company. "We remain confident this judgment will be upheld."
FDA has approved a biologics license application (BLA) submitted by Gen-Probe Inc. (San Diego) for its amplified nucleic acid test that simultaneously detects HIV-1 and HCV. "We're expecting good things from this approval," says company president Hank Nordhoff. The assay is currently being used by the American Red Cross, the Association of Independent Blood Centers, the United States military, and a select number of America's Blood Centers affiliates under an investigational new drug protocol. Nordhoff says the approval should boost usage of the product at the centers.
"Currently, only four of 13 America's Blood Centers affiliates use the test; hopefully this number will rise now that we have the BLA," says Nordhoff. "Blood banks that sell blood using an approved test do better in the marketplace, and our test is the only one like this on the market."
Nordhoff says the approval caps off a seven-year development span for the test, and the company is pleased with the final outcome. "We are competing with some of the biggest players in the industry and holding our own," he says.
Chiron Corp.
(Emeryville, CA) will be distributing the assay as the Procleix HIV-1/HCV assay.
Rheologics
Inc. (Exton, PA) acquired Cytometrics (New Castle, DE), a company
that develops noninvasive, point-of-care (POC) instrumentation for blood-vessel
imaging. Rheologics researches treatment and diagnosis of cardiovascular disease
and hopes to expand its development of new POC medical devices with the acquisition.
Cytometrics' core technology, the Cytoscan, captures still images of illuminated
subject matter and processes them using a set of algorithms. The technology
enables physicians to monitor perfusion changes in internal organs. Rheologics
plans to use the technology to clarify the structure of blood movement in the
capillaries.
Metrika Inc. (Sunnyvale, CA) announced the availability of its AlcNow CLIA-waived diabetes monitor. According to the company, AlcNow is the only device cleared by FDA for prescription use by diabetes patients to obtain home-based HbAlc test results. Intended for use by healthcare professionals and patients, the AlcNow device determines quantitative HbAlc levels in eight minutes.
"With AlcNow, any caregiver can get an accurate picture of their patient's diabetes control within minutes and make important treatment decisions on the spot," says Michael Allen, company CEO.
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