Nanogen Launches MTHFR Protocol; Company Expands Platform Menu With Fourth DNA-Based Protocol
SAN DIEGO, Nov. 6 /PRNewswire/ -- Nanogen, Inc. (Nasdaq: NGEN - news) announced today that it has completed internal validation of a DNA-based research protocol for MTHFR. This is a mutation associated with cardiovascular disease and the pathology of thrombosis, for use in research laboratories on the NanoChip® Molecular Biology Workstation. The anticipated users of the protocol include genetic research labs as well as CLIA (Clinical Laboratory Improvement Act) certified laboratories that will have the option to further develop and validate these protocols for internal use in a ``home-brew'' format.
This is the fourth DNA-based research protocol that Nanogen has internally validated for use on the NanoChip® Molecular Biology Workstation. All four protocols are designed to help researchers identify genetic links in illnesses that may lead to improved treatment and preventative decisions made in patient care. The Company plans to pursue cGMP status for its facility so that it may convert the four protocols to ASR models starting in 2002.
``We are delivering on our stated commitment to aggressively develop and validate a wide menu of protocols that can be performed on our NanoChip® System,'' said Randy White, Chief Executive Officer of Nanogen. ``We believe a key factor in the adoption of the NanoChip® Workstation will be the expansion of our menu of internally validated protocols. This rapid expansion, including the analysis of mutations in both singular and multiplexed formats, helps demonstrate the flexibility and power of our electronic-based array.''
``Nanogen is the first entity to have obtained a non-exclusive license to the MTHFR mutation from Variagenics, Inc.,'' commented Taylor Crouch, Variagenics' President and CEO. ``This relationship with Nanogen represents an important step in the validation of our pharmacogenomics business model, as well as our ongoing partnership program. We believe that Nanogen's electronics-driven technology is well-suited to help maximize the value of MTHFR polymorphism testing by providing a highly efficient and accurate system that has the potential to impact medical practice.''
Nanogen's goal is to become the leading provider of electronic microarray technology with the required accuracy, simplicity and flexibility necessary to bridge the gap between the research and clinical settings. The Company is seeking to establish the NanoChip® System as the standard platform for the detection of genetic mutations and to develop applications for future clinical use. To date, the Company has developed and internally validated research protocols for the detection of the Factor II and Factor V Leiden gene mutations, a multiplexed format Factor II/Factor V gene mutation combination, and the MTHFR gene mutation, all associated with cardiovascular disease. Nanogen markets its NanoChip® Molecular Biology Workstation to scientists and genomics laboratories. The NanoChip® System is intended for research use only and not for use in diagnostic procedures. For additional information please visit Nanogen's web site at www.nanogen.com... |
