Idaho Technology Offers Analyte Specific Reagent (ASR) Products
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.
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Source : http://www.prweb.com/releases/2005/1/prweb193832.htm