German-based therapeutic developer Pharis Biotec GmbH, and Nichols Institute Diagnostics, a wholly-owned subsidiary of Quest Diagnostics Incorporated , announced today that Pharis Biotec has granted an exclusive license to Nichols Institute Diagnostics for patented technology needed to develop a diagnostic test to measure parathyroid hormone, essential in the assessment of calcium metabolism and bone health. The technology is featured in a new independently validated test developed by Quest Diagnostics, the Bio-Intact PTH (1-84) assay, for use by clinical and research endocrinologists, hospitals and dialysis centers. The Bio-Intact PTH (1-84) assay offers benefit over current PTH assays in the management of patients with chronic renal failure and renal bone disease. These patients have elevated levels of PTH fragments in blood. Preliminary studies also indicate that Bio-Intact PTH (1-84) offers superior diagnostic sensitivity for primary hyperparathyroidism, or parathyroid gland tumors.
The licensing agreement covers rights to U.S. Patent No. 6,030,790, issued to Pharis Biotec, which describes a method of detecting biologically active human parathyroid hormone. The license also extends to similar pending patents in Japan and major European countries.
The Bio-Intact PTH (1-84) test provides a more accurate measurement than current PTH assays by measuring the whole, or "intact," 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 immediate N-terminal region of PTH, which is recognized as being 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.
An independently validated version of the Bio-Intact PTH (1-84) test is being performed exclusively for physicians, hospitals and commercial laboratories by Quest Diagnostics' Nichols Institute reference laboratory, in San Juan Capistrano, Calif., and is being offered throughout the Quest Diagnostics laboratory network. In addition, Nichols Institute Diagnostics, also based in San Juan Capistrano, Calif., is developing the test for multiple platforms. A version of the Bio-Intact PTH (1-84) test has been developed for its Nichols Advantage® automated testing platform and is currently awaiting FDA clearance.
About Pharis Biotec
Pharis Biotec focuses on development and commercialization of proprietary discoveries in the field of peptide biology. These activities are targeted for human therapeutic and diagnostic applications, usually through partnering with pharmaceutical research and development. Peptides are small proteins that modulate life functions by shuttling information between organs. Nature has streamlined these molecules, gradually molding them into perfect regulators of the complex networks that maintain human life. These peptides, perfected by nature and developed by Pharis Biotec, have great potential as new drugs for Osteoporosis, Diabetes mellitus and as antibiotics. Additional company information can be found on the Internet at: http://www.pharis-biotec.com/.
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, tumor markers 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 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.
SOURCE: Quest Diagnostics and Pharis Biotec GmbH
Contact: Gary Samuels of Quest Diagnostics, 201-393-5700