>>SAN DIEGO, Oct. 15 /PRNewswire/ -- Nanogen, Inc. (Nasdaq: NGEN - news) announced today its progress in the development of its molecular diagnostics, biological warfare and human identification programs as highlighted in the Company's presentation at the UBS Warburg Global Life Sciences Healthcare Conference, which took place on Friday, October 12, 2001.
Genetic Research and Pathway to Molecular Diagnostics
In the conference, Nanogen discussed the advantages of its core technology and how the Company believes that it may leverage its technological strengths to become a leading supplier of analytical devices to the genetic research market and eventually molecular diagnostic tests to the clinical diagnostic market. Nanogen stated it is the only company that has a commercial product on the market, the NanoChip® System, that uses electronically enhanced hybridization of complementary DNA strands.
Nanogen plans to obtain the necessary regulatory approvals to allow its technology, currently used by research institutions and clinical research laboratories, to be used in the molecular diagnostics market. In that market, quality, operational simplicity and cost effectiveness are important adoption criteria for new technology. Nanogen said that it believes it has met those criteria in the research setting, and will focus its efforts on demonstrating the applicability of those advantages to the molecular diagnostics field.
The Company reiterated that in a significant number of research studies to date, the NanoChip® System has achieved 100% accuracy in the detection of SNPs. In addition, these studies have demonstrated the system's flexibility and speed of analysis. A customer study has also shown advantages in consumable costs as compared to a competing technology. Moreover, Nanogen's technology allows researchers to perform ``multiplex'' assays (the ability to run assays that determine the presence or absence of multiple genetic mutations at the same time and on the same chip). Nanogen is currently developing technology to allow the on-chip amplification of DNA material directly on the NanoChip® cartridge, which if successful, eliminates a time- consuming preparatory step and folds it into a single, simplified detection procedure. Nanogen believes these advantages will make its technology an attractive candidate for the molecular diagnostics market.
Nanogen has already launched an internally validated research protocol for Factor V Leiden, seeks to add four other such protocols by the end of the year, and has other protocols under development. It plans to introduce analyte specific reagents or ASRs early in 2002 and then work towards obtaining regulatory clearance or approval for molecular diagnostic tests, including petitioning for uniquely applicable reimbursement codes.
Biological Warfare and Human Identification Activities
Nanogen has received a number of U.S. government grants to further its biowarfare and human identification programs. Nanogen has been working on its biowarfare and human identification programs with U. S. governmental agencies since 1997. Nanogen has created and delivered to the U.S. Government a prototype portable field-based detection device and is currently developing additional devices and assays for detecting biowarfare agents and infectious diseases. Nanogen is working towards a self-contained portable system where the amplification and detection of DNA can occur quickly to enable the rapid testing of potential biowarfare threats. The Company is also using certain government funding to further develop applications relating to the use of short tandem repeats (STRs) and single nucleotide polymorphisms (SNPs) for forensics and other human identification purposes.
Specific current development efforts include three grants from The Defense Advanced Research Projects Agency to develop an integrated microlaboratory and assay protocols to analyze simulated biowarfare targets. In addition, Nanogen has two Dual Use Science and Technology grants administered by the U.S. Army to develop assays and associated hardware for detecting biowarfare agents and infectious diseases. Nanogen also has a grant through the National Institute of Justice for the development of forensic tools relating to the use of STRs and SNPs. In addition, included in the third quarter placements previously announced, Nanogen sold a NanoChip® System to a government institution that is interested in developing STR and SNP assays for criminal identification purposes.
``Nanogen has received over $14.5M in government funding and commitments to support its biowarfare and human identification efforts. The grants and investments Nanogen makes in biowarfare helps support our primary goal of providing advanced solutions for medical diagnostics,'' said Randy White, Chief Executive Officer of Nanogen.
Nanogen's goal is to be 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 a research protocol for the detection of the Factor V Leiden gene mutation 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.<<
snipped the safe harbor boilerplate
Be interesting to see how it goes tomorrow. I'll be playing the bioterrorism whipsaws in my usual fashion. Already wrote and bought back one round of calls, and now started another . . . Cost basis coming down and down as the months go by . . .
Cheers, Tuck |
