Idaho Technology, Inc. today announced that it is now registered with the U.S. Food and Drug Administration (FDA) to develop, manufacture, and sell Analyte Specific Reagent (ASR) products for molecular diagnostics.
Salt lake City, UT (PRWEB) January 5, 2005 -- Idaho Technology, Inc. today
announced that it is now registered with the U.S. Food and Drug Administration
(FDA) to develop, manufacture, and sell Analyte Specific Reagent (ASR) products
for molecular diagnostics. The first ASR products released by Idaho Technology
are custom DNA probes and primers, which can be ordered by clinical laboratories
in the U.S. for in vitro human diagnostics. This announcement also follows a
recent grant of license by Roche Diagnostics that provides Idaho Technology with
rights under Roche’s PCR-related patents to make, use and sell products in the
field of in vitro diagnostics.
“Idaho Technology’s ASR products are manufactured under Current Good Manufacturing Practices (CGMP). We can now offer clinical laboratories the opportunity to develop in vitro diagnostic assays together with Idaho Technology under a superb quality program,” said Raymond Tarr, Idaho Technology’s Director of Sales & Marketing. “Enhancing our ability to serve our diagnostic research partners is the overall business strategy of Idaho Technology.”
ASR products can be used by clinical laboratories qualified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) guidelines. Idaho Technology also is a provider of innovative devices for nucleic acid detection and analyses, and holds exclusive licenses to key technologies such as rapid PCR, real-time PCR using SYBR Green I, fluorescence resonance energy transfer (FRET) hybridization probe, and DNA melting analysis. These technologies are currently used worldwide in clinical diagnostics, life science research, food and environmental safety, and homeland security applications.
About Idaho Technology, Inc.
Idaho Technology, Inc. is a privately held biotechnology company based in Salt Lake City, Utah. Founded in 1990, Idaho Technology worked together with the University of Utah to develop rapid PCR technology and other innovative technologies for nucleic acid detection and analysis. Through funds from the United States Department of Health and Human Services and the Department of Defense, the company has created many commercial instruments and reagents for use in research and applied fields. Researchers, medical technicians, law enforcement officers, and soldiers in the field use the company's devices to detect or study human genetics, disease-causing organisms or biothreat agents.
Source: Idaho Technology, Inc. www.idahotech.com.
# # #
Source : http://www.prweb.com/releases/2005/1/prweb193832.htm