HOFFMANN-LA ROCHE EXPANDS ACCESS TO PCR TECHNOLOGY FOR DIAGNOSTIC TESTING SERVICES
HOFFMAN-LA ROCHE EXPANDS ACCESS TO PCR TECHNOLOGY FOR DIAGNOSTIC TESTING SERVICES BRANCHBURG, N.J., Feb. 11 /PRNewswire/ -- Roche Molecular Systems (RMS) today announced a new licensing policy for diagnostic testing services for its revolutionary PCR technology. The new policy clears the way for a continued increase in the availability of current PCR applications and will accelerate research to find important new uses for the technology. "Roche has a long-term commitment to working in close partnership with the scientific community -- and to be responsive to its needs -- in order to ensure that PCR technology reaches its full potential as rapidly as possible," said Kathy Ordonez, president of Roche Molecular Systems, the new Roche business unit established to develop PCR-based products. The new Roche licensing policy will provide all laboratories -- including research institutions and public and private diagnostic facilities -- with the freedom to use PCR for all human diagnostic testing services. Key elements of the new Roche PCR diagnostic licensing policy include: -- rights to perform tests for a wide variety of diseases and conditions, such as infectious diseases, genetic diseases, genetic predisposition to diseases, cancer, tissue transplant typing and parentage determination. -- technology exchanges between Roche and the licensee are optional. -- for academic and non-profit institutions performing diagnostic testing services -- no up-front licensing fee or annual minimum payment will be required and royalty rates will be as low as 9 percent of sales. In order to assure PCR testing results of the highest quality, licensees will be expected to meet all government, regulatory and independent professional requirements. Roche will not impose any other specific quality requirements. The new licensing policy is expected to encourage, for example, the development of new or improved tests for genetic and infectious diseases. Recent findings that link specific genes with diseases suggest that PCR will become an even more important tool in both research and diagnosis in the future. "The new Roche Molecular Systems licensing policy reflects Roche's desire to see their most powerful DNA amplification method -- PCR -- widely used by rendering simple the mechanism and rules of the license agreement," said C. Thomas Caskey, M.D., director, Institute for Molecular Genetics, and researcher, Howard Hughes Medical Institute, Baylor College of Medicine. "This action will facilitate PCR's further domination of amplification technology. The public and scientific communities will benefit by the availability of PCR's precise and rapid features," he added. In developing its new PCR licensing policy, Roche consulted with leaders of the scientific community. Input was provided by such leading institutions as the Baylor College of Medicine, The Mayo Clinic, Johns Hopkins University School of Medicine and the National Center for Human Genome Research. PCR, or polymerase chain reaction, allows a single strand of DNA to be replicated millions of times in less than two hours. The technology was invented in 1983 by Kary Mullis. Using PCR, scientists can zero in on a target DNA segment and amplify it to the point where it can be readily identified. In the six years since the method was published by scientists at Cetus Corporation, PCR has revolutionized molecular biology and genetics. Previously, Roche licensed SmithKline Beecham Clinical Laboratories, Inc. and Methpath Inc. to perform PCR testing services, along with Roche Biomedical Laboratories. More than 20 other laboratories are also currently licensed and offer PCR-based diagnostic testing services. Other applications of PCR technology, such as environmental, food testing, research and identity testing, and other industrial applications, will be licensed in collaboration with The Perkin-Elmer Corporation, with whom Roche has formed a strategic alliance. The announcement of the new PCR diagnostic licensing policy follows Roche's acquisition, this past December, of the rights to the PCR technology from Cetus Corporation and the establishment of Roche Molecular Systems. Hoffmann-La Roche, with worldwide headquarters in Basel, Switzerland, and U.S. headquarters in Nutley, N.J., is a world leader in original research and development in the healthcare field. Through the company's three diagnostic divisions, Roche Biomedical Laboratories, Inc., Roche Diagnostic Systems, Inc. and Roche Molecular Systems, Inc., innovative and cost-effective testing products and services are made available to physicians, patients, hospitals, and laboratories worldwide. -0- 2/11/92 /CONTACT: Paula Evangelista of Hoffmann-La Roche, 201-235-5929/ CO: Hoffmann-La Roche, Inc. ST: New Jersey IN: MTC SU:
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