Chiron Diagnostics and Metra Biosystems Announce FDA Clearance for Automated Bone Resorption Assay.MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Oct. 29, 1996--Chiron Diagnostics, a business unit of Chiron Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CHIR CHIR Chiricahua National Monument (US National Park Service) ) and Metra Biosystems, Inc. (NASDAQ: MTRA MTRA Monster Truck Racing Association MTRA Money Transmitter Regulators Association MTRA Medical Technical Research Associates (San Bruno, CA) MTRA Medizinisch Technische Radiologie Assistentinnen ) today announced that Chiron Diagnostics has received U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) clearance to market ACS (Asynchronous Communications Server) See network access server. :Dpd(TM), an automated bone resorption immunoassay Immunoassay An assay that quantifies antigen or antibody by immunochemical means. The antigen can be a relatively simple substance such as a drug, or a complex one such as a protein or a virus. based on Metra's Pyrilinks(R)-D technology. Designed for use on the ACS:180(R) automated immunoassay system, ACS:Dpd is believed by the companies to be the first automated bone resorption immunoassay cleared by the FDA for clinical use. FDA clearance of ACS:Dpd was granted in the name of Ciba Corning Diagnostics Corp. Recently, the company announced its name change from Ciba Corning Diagnostics Corp. to Chiron Diagnostics Corp., effective Nov. 1, 1996. The ACS:Dpd assay provides quantitative measure of the urinary excretion of deoxypyridinoline (DpD) crosslinks, an accepted marker of bone resorption (loss). Dpd is released from bone in elevated quantities when bone loss exceeds formation, a situation that can lead to the development of osteoporosis and other degenerative bone conditions. As a complementary tool to the use of x-ray techniques, the ACS:Dpd assay may provide physicians and patients with a more complete and dynamic picture of bone breakdown than is possible using x-rays alone. "By combining Metra's Pyrilinks-D technology with our ACS system technology, we have been able to speed up development and access to this very important marker," said Richard Barker, Ph.D., president of Chiron Diagnostics. "Our hope is that this assay may ultimately provide physicians with one of the most advanced tools for patients that suffer from degenerative bone diseases." Metra Biosystems' president and chief executive officer George Dunbar said, "This FDA clearance advances Metra's goal of providing our Pyrilinks-D and other technologies in the growing installed base of automated systems, and is clearly an important development for our company. Of course, Metra's own sales force will continue to market Pyrilinks-D and other Metra products in manual format for clinical and research use to laboratories in the U.S., Europe and Asia Pacific." Chiron Diagnostics combines biological technologies, chemistry and advanced systems to empower physicians with information to better manage therapies and help patients understand their disease. Chiron Diagnostics' products include automated instrumentation, reagents, controls and nucleic acid nucleic acid, any of a group of organic substances found in the chromosomes of living cells and viruses that play a central role in the storage and replication of hereditary information and in the expression of this information through protein synthesis. systems to quantify viral load viral load n. The concentration of a virus, such as HIV, in the blood. viral load, n a measure of the number of virus particles present in the bloodstream, expressed as copies per milliliter. . Chiron Diagnostics focuses its advanced diagnostics technologies in Critical Blood Analysis, Clinical Chemistry, Endocrinology, Infectious Disease Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. , Allergy and Oncology, and is a business unit of Chiron Corp., headquartered in Emeryville, Calif. Metra Biosystems, Inc. is a leader in developing and commercializing diagnostic products for the detection and management of metabolic bone diseases metabolic bone disease Any defect in bone absorption or deposition that alters the PTH/calcium-phosphate/vitamin D axis, often with ↑ bone fragility Etiology Fibrous dysplasia, Langerhans' cell histiocytosis/histiocytosis X, acromegaly, corticosteroid therapy, and disorders. Metra's strategy is to offer a portfolio of diagnostic products that will provide physicians with comprehensive clinical information regarding the metabolism of bone and other connective tissues. Metra has developed and is currently marketing for either clinical or research use: two immunodiagnostic immunodiagnostic pertaining to diagnosis by immune reactions. tests to measure bone resorption (loss); two immunodiagnostic tests to measure bone formation and one immunodiagnostic test to measure bone growth disorders. In addition, Metra is developing a portable ultrasound device designed to assess bone fragility and biochemical markers to detect cartilage disorders. -0- Statement regarding Metra Biosystems: The matters contained in this news release, except for the historical information set forth herein, are forward-looking statements that are dependent on certain risks and uncertainties including such factors, among others, as the uncertainty of market acceptance for biochemical markers, Metra's dependence upon international sales, the uncertainty of international regulations, Metra's reliance upon collaborative relationships, the uncertainty of ultrasound technology development, competition and regulation and the other risk factors listed in the Company's Prospectus dated April 23, 1996 and Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the fiscal year ended June 30, 1996. CONTACT: Metra Biosystems, Inc. Kurt Amundson, 415/903-9100 or Chiron Diagnostics Judith Rossi, 508/668-4875 |
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