DiaSorin Receives Clearance for LIAISON(R) 25-OH Vitamin D and Parathyroid Hormone Assays.STILLWATER, Minn., Feb. 17 /PRNewswire/ -- DiaSorin Inc. announced Friday, February 13, that it received Food and Drug Administration clearance for the Company's LIAISON(R) 25-hydroxy Vitamin D and LIAISON(R) N-TACT(TM) PTH PTH abbr. parathyroid hormone Parathyroid hormone (PTH) A chemical substance produced by the parathyroid glands. This hormone is a major element in regulating calcium in the body. Assays. The Company will begin immediate placement of its LIAISON(R) random- access chemiluminescent analyzer in hospitals and clinical reference laboratories nationwide. Testing for 25-hydroxy Vitamin D and PTH provides the physician with definitive analysis of nutritional Vitamin D deficiency Vitamin D Deficiency Definition Vitamin D deficiency exists when the concentration of 25-hydroxy-vitamin D (25-OH-D) in the blood serum occurs at 12 ng/ml (nanograms/milliliter), or less. , an acute concern in the elderly and in individuals with dark complexions. "We are proud to be the leader in bone and mineral diagnostics with the introduction of DiaSorin's third generation of 25-hydroxyvitamin D testing, a LIAISON(R) chemiluminescence chemiluminescence /chemi·lu·mi·nes·cence/ (kem?i-loo?mi-nes´ens) luminescence produced by direct transformation of chemical energy into light energy. assay," said Stephen P. Gouze, President and General Manager of DiaSorin Inc. "LIAISON(R) offers the only antibody-based Vitamin D assay available in an automated, random access chemiluminescence platform, providing the same consistent results physicians have seen from DiaSorin's radioimmunoassay for over a decade. Patients benefit from the rapid results (35 minutes to first result) and world class-assay reliability of the LIAISON(R) system. Laboratories benefit from high throughput (180 tests per hour) and complete walk-away automation from extraction through data output." Over 800 LIAISON(R) systems are in use worldwide with a menu of over 50 diagnostic tests including hepatitis, infectious disease and autoimmune assays. DiaSorin will be adding these and other assays in the United States as FDA clearance is received. DiaSorin has a worldwide workforce of over 500 employees with corporate headquarters in Saluggia, Italy. U.S. operations, located in Stillwater, Minnesota, include research and development, sales, and ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001-registered manufacturing facilities. CONTACT: Rebecca Aistrup, Director of Marketing of DiaSorin Inc., +1-651-351-5735 Web site: http://www.diasorin.com/ |
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