Metra Biosystems Receives FDA Clearance for Monitoring of Osteoporosis Treatments.MOUNTAIN VIEW, Calif.--(BW HealthWire)--June 8, 1998--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 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 of Metra's 510(k) premarket notification for the use of Alkphase-B(R), its serum-based laboratory test for bone formation, to monitor response to anti-resorptive therapies, like Fosamax(R) (alendronate alendronate /alen·dro·nate/ (ah-len´dro-nat) a bisphosphonate calcium-regulating agent used in the form of the sodium salt to inhibit the resorption of bone in the treatment of osteitis deformans, osteoporosis, and hypercalcemia related ) and estrogen, in the treatment and prevention of osteoporosis. In addition, Alkphase-B is the first serum test cleared for use as a predictor of skeletal response to hormone replacement therapy Hormone Replacement Therapy Definition Hormone replacement therapy (HRT) is the use of synthetic or natural female hormones to make up for the decline or lack of natural hormones produced in a woman's body. . "With our Pyrilinks(R)-D assay and these additional claims for Alkphase-B, Metra is now positioned as the only diagnostics company with regulatory clearance for both bone resorption and bone formation assays," said George Dunbar, Metra's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "The ability to offer physicians a full complement of tools for bone health management is a significant strategic achievement." The new 510(k) clearance was based on two separate randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , placebo-controlled clinical trials involving alendronate and hormone replacement therapy. In one of the studies, Alkphase-B was used to compare bone-specific alkaline phosphatase alkaline phosphatase /al·ka·line phos·pha·tase/ (ALP) (fos´fah-tas) an enzyme that catalyzes the cleavage of orthophosphate from orthophosphoric monoesters under alkaline conditions. levels in post menopausal women diagnosed with osteoporosis, who received either alendronate and a calcium supplement or a calcium supplement alone. In the second study, Alkphase-B was used to compare bone-specific alkaline phosphatase levels in healthy post-menopausal women, who received either estrogen replacement therapy estrogen replacement therapy n. Abbr. ERT The administration of estrogen, especially in postmenopausal women, to relieve symptoms and conditions associated with estrogen deficiency, such as hot flashes and osteoporosis. or a placebo. Both studies demonstrated that Alkphase-B can be used to monitor the effects of drugs used for the treatment or prevention of osteoporosis. "The studies confirm the utility of Alkphase-B as an indicator of treatment response," said John Coombes Coombes is a hamlet and civil parish in the Adur District of West Sussex, England. It is located three miles (5km) north of Shoreham by Sea on the River Adur. The 11th century village church has frescoes, some of the most important in England, and painted about 1100 A.D. , Metra's Vice President of Marketing and Sales. "We believe this information is critical for patients to receive maximum therapeutic benefit." Metra Biosystems, Inc. develops and commercializes diagnostic products for the detection and management of metabolic bone and joint diseases. The Company's goal is to provide products for the comprehensive clinical evaluation of bone and connective tissue health. With six immunodiagnostic immunodiagnostic pertaining to diagnosis by immune reactions. products currently on the market, including Pyrilinks-D--the Dpd test, Metra believes it is the leading company in this new field in terms of total product revenues. Additional information is available on the Company's web site at: www.metrabio.com. The matters contained in this press 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, competition and regulation and the other risk factors listed in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 1997 and in the company's periodic reports on Form IO-Q and in other filings with the Securities and Exchange Commission.
CONTACT: Metra Biosystems, Mountain View
George Dunbar (investors), 650/903-9100
Karen Shepard (products), 650/903-9100
or
Edelman Public Relations
Susan Sorensen (PR), 415/433-5381
or
Edelman Financial
Emmanuelle Thiney (investors), 212/704-8239
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