>>SAN DIEGO, March 20 /PRNewswire-FirstCall/ -- Nanogen, Inc. (Nasdaq: NGEN - news) announced today the introduction of its first Analyte Specific Reagent (ASR), designed for the detection of Factor V Leiden, a gene mutation associated with cardiovascular disease and the pathology of thrombosis. The introduction of the ASR is an important step in the Company's strategy to build its consumable revenue base. The Company has put in place policies and procedures that will enable it to meet the Quality System Regulations, or QSRs, in its facilities. QSR Compliance is a regulatory requirement of the FDA that is intended to ensure the quality of medical devices and related products.
Nanogen's Factor V Leiden ASR determines if the Factor V Leiden gene is present in a blood sample by detecting the presence of a certain characteristic gene polymorphism. The ASR consists of active reagents that CLIA-certified high complexity laboratories can use in their tests to detect this mutation.
``Testing for Factor V Leiden, one of the most common inherited links to the pathology of thrombosis, can provide a physician with important information relating to risk assessment and prevention,'' said Howard C. Birndorf, Executive Chairman and Co-Founder of Nanogen. ``Our ASR for Factor V Leiden will now offer CLIA-certified high complexity laboratories a more complete solution than our ''home brew`` protocol currently provided. Because the Factor V ASR can be used on the NanoChip® Molecular Biology Workstation, this makes the NanoChip® System an even more competitive platform in the fast growing market of molecular diagnostics.''
Factor V Leiden is the most common hereditary blood coagulation disorder present in three to seven percent of the population in Europe and the United States. Individuals who are carriers of Factor V Leiden have an increased risk of thrombosis, a clot that hinders the passage of blood through the vessels potentially causing heart attacks, strokes and other related illnesses.
``The introduction of our first ASR and achieving QSR compliance meets a major business objective we set out to achieve this quarter. We will continue to expand both the breadth and depth of our menu with the launch of additional protocols and ASRs, which we believe will create a significant opportunity to increase consumable product revenues related to the use of our NanoChip® platform,'' said Randy White, Chief Executive Officer of Nanogen. ``Moving forward, our strategy is to continue down the regulatory pathway to reach our ultimate goal of offering FDA-cleared or approved products on a case-by-case basis to a wide range of customers, including clinical reference laboratories.''<<
snip
Cheers, Tuck |
