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|Quidel Launches New Biochemical Bone Marker Test|
SAN DIEGO, Feb. 1 /PRNewswire/ -- Quidel Corporation (Nasdaq: QDEL) today announced that it has launched the Metra(TM) Helical Peptide immunoassay, a urine test for measuring the breakdown of collagen. This proprietary assay for a new biochemical bone marker expands Quidel's portfolio of bone health products. It was initially intended for use by researchers seeking to characterize the degradation of bone tissue that occurs in osteoporosis and related diseases, and in detecting the effects of therapies that halt such destruction. Metra Helical Peptide is now being sold for this research use through Quidel's direct sales operations in the U.S. and Europe and its distributor network throughout the world. A U.S. patent protects the assay and the peptide it measures, and additional patents are pending.
"Results from initial clinical research suggest that this unique new marker is very sensitive to alterations in bone turnover produced by bone disease and anti-osteoporosis therapy," said John Tamerius Ph.D., General Manager of Quidel's Northern California operations that are responsible for developing and manufacturing Quidel's bone health diagnostic products. "The assay is also reactive in virtually all animal species that are used in the preclinical phase of drug development. Metra Helical Peptide testing should therefore benefit pharmaceutical researchers in all phases of developing new bone-active compounds," added Dr. Tamerius.
Bones are living tissue containing a mineralized matrix of predominantly type I collagen fibers. Bone tissue is broken down and replenished in a normal, daily process called "turnover" that replaces aging bone and makes calcium available for use by other tissues. Osteoporosis is a disease characterized by decreased mass and quality of bone tissue, increased turnover, and a corresponding increased risk for bone fracture. In this disease, type I collagen is degraded more quickly than it is produced and incorporated into new bone. The degradation fragments of collagen appear in the blood and urine of patients where they can be detected by sensitive and specific immunoassays. "We anticipate that Metra Helical Peptide will be a valuable research tool for detecting excessive bone deterioration and for assessing the effects of bone-active therapies," said S. Wayne Kay, President & Chief Operating Officer of Quidel Corporation.
Quidel Corporation discovers, develops, manufactures and markets point-of-care, rapid diagnostics for detection of medical conditions and illnesses. These products provide accurate, rapid and cost-effective diagnostic information for acute and chronic conditions that affect women's health throughout the phases of their lives including reproductive status, pregnancy management and osteoporosis. Quidel also provides point-of-care diagnostics for infectious diseases, including influenza A and B, strep throat, H. pylori infection, chlamydia and infectious mononucleosis. Quidel's products are sold to healthcare professionals for use in physicians' offices, clinical laboratories and pharmacies, and to consumers through organizations that provide private label, store brand products. These tests provide diagnostic information to enable rapid treatment and improve health outcomes, lower costs, and increase patient satisfaction.
This press release contains forward-looking statements regarding Quidel's future activities within the meaning of the federal securities laws. These forward-looking statements involve material risks and uncertainties. Many possible factors could affect the future results and performance of Quidel's products, such that actual results and performance may differ materially. If Quidel's products fail to perform as expected, or if there is lower consumer demand for these products than expected, Quidel's financial condition and operating results may be materially and adversely affected. Quidel's financial condition and operating results may also be materially and adversely affected by a number of other factors, including, without limitation, seasonality, adverse changes in competitive and economic conditions, actions by the Company's distributors, manufacturing and production delays or difficulties and adverse actions or delays in product reviews by the FDA. Please see the discussion of these and other factors in Quidel's annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. For more information, please visit Quidel's web site at http://www.quidel.com.