Originally Published IVD Technology March 2002
Industry News
Notable
In
January, Response Biomedical Corp. (Burnaby, BC, Canada) received FDA
clearance to market its RAMP reader and RAMP myoglobin test for the rapid diagnosis
of heart attacks. The system comprises a portable fluorescence reader and disposable
test cartridges, and provides a quantitative measurement of myoglobin levels
in a whole-blood sample. According to the company, the system delivers results
in less than 15 minutes.
"FDA clearance validates the performance of the system, providing a level of assurance that RAMP will play an important role in both the clinical and environmental testing fields," says Bill Radvak, company CEO and president.
Additional
tests under development by the company include two other cardiac markers and
tests for the diagnosis and monitoring of prostate cancer, therapeutic drugs,
and environmental agents.
Cepheid (Sunnyvale, CA) has recently supplied field-ready, PCR-based DNA test kits for rapid detection of Bacillus anthracis (anthrax), Yersinia pestis (plague), Francisella tularensis (tularemia), and Clostridium botulinum (botulism) to the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). The tests were developed in collaboration with USAMRIID under a Department of Defense contract and comprise DNA sequences identified and validated by USAMRIID for biothreat agent detection and Cepheid’s reagent formulations.
Unlike most PCR reagents, Cepheid’s formulations are designed to remain stable for many months at room temperature. Thomas Gutshall, Cepheid CEO and chairman, says the tests offer high sensitivity and ambient temperature stability and are designed to reduce mixing errors.
"Delivery
of these assays is the culmination of an intense development partnership between
USAMRIID and Cepheid to produce the first comprehensive series of high-performance,
high-stability tests for rapid detection of biothreat agents," says Colonel
Erik A. Henchal, chief of diagnostic systems at USAMRIID. Gutshall says Cepheid
will supply tests to other government agencies and plans to apply the technology
to other applications.
Bayer
Diagnostics (Tarrytown, NY) and Burrill & Co. (San Francisco),
a life sciences merchant bank, recently formed the Burrill Diagnostics Capital
Fund to promote the application of bio-based technologies and to provide growth
capital to product-based companies. The $50 million venture-capital fund is
part of a group of life sciences funds managed by Burrill & Co., which focuses
on biotechnology, pharmaceuticals, diagnostics, human healthcare, nutraceuticals,
and bioprocesses. Rolf Classon, president of Bayer Diagnostics, says the company
hopes to use technology fostered by the fund to improve its diagnostic products.
"Our association with the Burrill Diagnostics Capital Fund complements
our ongoing desire to gain insight into new technologies that can make a positive
impact on human health," says Classon.
Copyright ©2002 IVD Technology
