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Quidel's Metra(TM) DPD Osteoporosis Test Gains Mandatory National Medicare Coverage
Metra DPD is intended to identify elevated bone resorption that is associated with osteoporosis and other metabolic bone diseases, in both women and men. Metra DPD is intended for use as an aid in monitoring patient response to hormonal and bisphosphonate therapies and in individuals diagnosed with osteoporosis.
"National Medicare coverage for Metra DPD is a significant step forward in making this test available and financially practical for Medicare beneficiaries who take anti-resorptive medications and whose physicians want to monitor bone resorption changes," said S. Wayne Kay, Quidel's President and CEO. "Although some Medicare carriers have reimbursed for the test, other carriers previously denied coverage. This coverage policy establishes mandatory national Medicare coverage for Metra DPD for women and men who are diagnosed with primary or secondary osteoporosis."
Nelson Watts, M.D., President of the International Society for Clinical Densitometry and Director of the University of Cincinnati Bone Health and Osteoporosis Center, said, "I am pleased that Medicare has taken this step to establish a national coverage policy for collagen crosslinks. The assay is clinically useful in the management of patients being treated for primary or secondary osteoporosis. Since this national coverage policy sets the parameters for all Medicare carriers to cover and reimburse for the test, it benefits patients covered by Medicare nationwide."
According to the National Osteoporosis Foundation, osteoporosis is a serious medical condition that threatens 28 million Americans, 10 million of whom have osteoporosis and another 18 million who have low bone mass, which increases their risk for osteoporosis. Oftentimes called the "silent disease," osteoporosis is frequently first diagnosed when an individual sustains a fracture. Annually, more than 1.5 million Americans suffer an osteoporotic fracture. Osteoporosis preventative and treatment measures include proper diet and calcium supplements, adequate exercise and anti-resorptive therapies. Patient response to therapy can be assessed with Metra DPD within a few weeks.
The Balanced Budget Act of 1997 mandated that CMS negotiate national coverage rules with an expert panel for some clinical laboratory tests and administrative procedures. Collagen crosslinks is one of only 23 analytes to be issued a Medicare national coverage policy, and the only analyte for assessing osteoporosis. According to the Final Rule published in the Federal Register on November 23, 2001, national coverage is allowed only for urinary collagen crosslinks tests used to "identify individuals with elevated bone resorption, who have osteoporosis in whom response to treatment is being monitored; predict response (as assessed by bone mass measurements) to FDA approved antiresorptive therapy in postmenopausal women; and assess response to treatment of patients with osteoporosis, Paget's disease of the bone, or risk for osteoporosis where treatment may include FDA approved antiresorptive agents, anti-estrogens or selective estrogen receptor moderators."
According to the Final Rule, Medicare will reimburse for "one or two base-line assays from specified urine collections on separate days; followed by a repeat assay about three months after starting anti-resorptive therapy; followed by a repeat assay every 12 months after the three-month assay." Subsequently, if there is a change in therapy, an additional test may be ordered three months after the change in therapy. The Dpd assay is widely available from the major national reference laboratories in the United States. The 2002 Medicare national fee limit for a collagen crosslinks test is $25.83.
Quidel has licensed the Dpd test to strategic partners who market the assay worldwide aboard proprietary automated analyzers. Diagnostic Products Corporation (DPC) markets the test as Immulite(R) Pyrilinks-D and Immulite(R) 2000 Pyrilinks-D, and Bayer Corporation markets the test as ACS:180(R) DPD and Immuno 1(R) DPD. The new Medicare coverage policy is also applicable to DPC and Bayer's adaptation of Dpd for their automated analyzers. DPC and Bayer pay royalties to Quidel for their Dpd tests sold worldwide on these analyzers.
Quidel also markets additional biochemical bone marker assays to assess bone resorption and bone formation and the QUS-2(R) Calcaneal Ultrasonometer to measure bone mass as an aid in the diagnosis of osteoporosis. Mr. Kay added, "We believe that our two core bone health technologies make Quidel a leader in the field of osteoporosis diagnostic technologies."
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.
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