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|Nation's Largest Osteoporosis Study Finds High Incidence of Undetected Cases|
SAN DIEGO, Dec. 19 /PRNewswire/ -- Quidel Corporation (Nasdaq: QDEL), a leading provider of rapid point-of-care (POC) diagnostic tests, today announced that the nation's largest osteoporosis study found a high incidence of undetected cases of osteoporosis. The Company believes that the study confirms the growth potential for Quidel's QUS-2(R) Calcaneal Ultrasonometer and Metra(TM) DPD products, currently marketed to primary care physicians as an aid in the early diagnosis and treatment management of low bone mass and osteoporosis.
A study published in the December 12, 2001 edition of the Journal of American Medical Association (JAMA) suggests that millions of women aged 50 and older who have not been assessed for osteoporosis may be at increased risk of bone fracture. [Siris E.S., Miller P.D., Barrett-Connor E., et al, Identification and Fracture Outcomes of Undiagnosed Low Bone Mineral Density in Postmenopausal Women: Results from the National Osteoporosis Risk Assessment, JAMA, 2001; 286:2815-2822.]
The nation's largest study of osteoporosis, National Osteoporosis Risk Assessment (NORA), found that almost half of the more than 200,000 postmenopausal women assessed in the study had low bone mass, putting them at increased risk of breaking a bone. Primary care physicians found that seven percent of women in the study were found to have osteoporosis. In addition, nearly 40 percent of the women were found to have low bone mass but were not yet osteoporotic. During the one-year follow-up period, the rate of bone fracture was four times higher for women with osteoporosis, and twice as high for women with low bone mass compared with women with normal bone density.
"Osteoporosis is a serious medical condition that threatens 28 million Americans. The NORA survey points to the need to diagnose and treat osteoporosis aggressively," said S. Wayne Kay, Quidel's President and Chief Executive Officer. "Having recently launched the QUS-2 to the primary care market in the U.S. and having just received national Medicare coverage for the Metra DPD test in November 2001, we are now giving primary care physicians tools for better patient management as an aid in the diagnosis and management of this oftentimes silent disease."
Mr. Kay added, "We believe that our two core bone health technologies, available to primary care physicians across the U.S., make Quidel a leader in the field of osteoporosis diagnostic technologies. The NORA study reaffirms our strategy to market Quidel's bone health products to the primary care market."
Quidel markets two osteoporosis diagnostic technologies to primary care physicians. The QUS-2 Calcaneal Ultrasonometer is a battery-operated, lightweight portable device that is used as an aid in diagnosing osteoporosis and predicting atraumatic fracture risk. Clinical studies with the QUS-2 concluded that the QUS-2 exhibits reproducible clinical performance that is similar to bone mineral density of the spine and hip in identifying women with low bone mass and discriminating women with fracture from those without fracture.
Metra DPD, a clinical laboratory test, is intended to identify elevated bone resorption that is associated with osteoporosis and other metabolic bone diseases. Metra DPD is intended for use as an aid in monitoring patient responses to hormonal and bisphosphonate therapies and in individuals diagnosed with osteoporosis. On November 23, 2001, the U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) issued its Final Rule for Medicare National Coverage for Collagen Crosslinks, a test marketed by Quidel under the tradename Metra(TM) DPD. This coverage policy establishes mandatory national Medicare coverage for Metra DPD for women and men who are diagnosed with primary or secondary osteoporosis.
The NORA study tested bone mass and evaluated other osteoporosis risk factors in 200,160 postmenopausal women, aged 50 and older, from 4,236 primary care practices in 34 states over one year. NORA was funded by Merck & Co. Inc. and managed by a steering committee comprised of osteoporosis investigators.
In addition to the Company's QUS-2 and Metra DPD products, Quidel markets other biochemical bone markers that are being studied worldwide by bone and mineral researchers to assess bone resorption and bone formation.
Quidel Corporation discovers, develops, manufactures and markets rapid point-of-care diagnostic tests for detection of medical conditions and illnesses. These products provide accurate, rapid and cost-effective diagnostic information for acute and chronic conditions associated with women's health, in areas such as reproduction and diseases of the elderly. Quidel also provides point-of-care diagnostics for infectious diseases, including influenza A and B, strep throat, H. pylori infection, chlamydia, infectious mononucleosis and bacterial vaginosis. 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. For more information, please visit Quidel's Web site at www.quidel.com .
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 (both domestically and internationally) 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.