Quest Diagnostics Incorporated , the nation's leading provider of diagnostic testing, information and services, announced today that its test manufacturing unit, Nichols Institute Diagnostics, received clearance from the U.S. Food and Drug Administration to market its new Bio-Intact PTH (1-84) proprietary diagnostic test kit to measure parathyroid hormone, essential in the assessment of calcium metabolism and bone health.
The FDA-cleared Bio-Intact PTH test kit is available on the popular Nichols Advantage® platform, a fully-automated benchtop chemiluminescence system made by Nichols Institute Diagnostics, based in San Juan Capistrano, Calif.
"This new FDA-cleared Bio-Intact PTH assay is the latest in a long line of innovative and proprietary endocrinology tests developed by Nichols Institute Diagnostics and Nichols Institute, which are recognized as leaders with the broadest menu of endocrine tests," said Lucia L. Quinn, Senior Vice President, Advanced Diagnostics, for Quest Diagnostics.
The Bio-Intact PTH test is the first fully-automated FDA-cleared test to recognize the entire parathyroid hormone molecule, rather than fragments of the molecule, which has a tendency to break up. Currently, PTH measurement is often complicated by the presence of inactive PTH fragments in blood, which impacts the clinical utility of such testing. In recognizing the entire PTH molecule, which consists of an 84-amino acid chain, the Bio-Intact PTH assay has specificity for the N-terminal region of PTH, which is considered essential for the biological effect of PTH. The Bio-Intact PTH test uses proprietary antibodies to bind to the first amino acids in the N-terminal region of the PTH 1-84 sequence.
About Nichols Institute Diagnostics
Nichols Institute Diagnostics manufactures and markets worldwide the highest quality, innovative, specialty immunoassays in the areas of thyroid function, bone and mineral metabolism, reproduction, growth, hypertension, anemia and adrenal/pituitary function. Fully-automated and semi-automated system options are available utilizing advanced direct label technology to meet the throughput needs of both large and small independent and hospital laboratories. Intra-operative point-of-surgery patient testing procedures are also available. Nichols Institute Diagnostics is a wholly-owned subsidiary of Quest Diagnostics Incorporated.
About Quest Diagnostics
Quest Diagnostics is the nation's leading provider of diagnostic testing, information and services with $3.4 billion in annual revenues. The company's diagnostic testing yields information that enables health care professionals and consumers to make better decisions to improve health. Quest Diagnostics offers patients and physicians the broadest access to diagnostic testing services through its national network of approximately 30 full-service laboratories, 150 rapid response laboratories and more than 1,300 patient service centers, where specimens are collected. Quest Diagnostics is the leading provider of esoteric testing, including gene-based testing, and is the leader in routine medical testing, drugs of abuse testing, and non-hospital- based anatomic pathology testing. Quest Diagnostics empowers health care organizations and clinicians with state-of-the-art connectivity solutions that improve practice management. Through partnerships with pharmaceutical, biotechnology and information technology companies, Quest Diagnostics provides support to help speed the development of health care insights and new therapeutics. Additional company information can be found on the Internet at: http://www.questdiagnostics.com/.
The statements in this press release which are not historical facts or information may be forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the outcome to be materially different. Certain of these risks and uncertainties are listed in the Quest Diagnostics Incorporated 2000 Form 10-K and subsequent filings.
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SOURCE: Quest Diagnostics Incorporated
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