This is a rather odd press release. It suggest the White House has endorsed the RAMP Anthrax test device based on an assessment last October that there was no reliable test available. Interesting way of looking at things.
U.S. White House Confirms Complete Lack Of Reliable Competition To Response Biomedical's RAMP(TM) Anthrax Test
RAMP Sensitivity And Reliability Were Not Evaluated As Part Of The Investigation That Led To The U.S. Office Of Science And Technology Policy (OSTP) Ruling
TSX Venture Exchange: RBM
VANCOUVER, BC, July 23 /CNW/ - Response Biomedical Corp. (RBM: TSX Venture Exchange), announces that the sensitivity and reliability of the RAMP(TM) Anthrax Test were not evaluated as part of the scientific study that led to the White House advisory (July 19, 2002) recommending against the use of rapid anthrax field tests. The recent recommendation issued by the U.S. Office of Science and Technology Policy (OSTP) reflects earlier findings by the U.S. Centers For Disease Control and Prevention (CDC), released in October of 2001, which also concluded that competing rapid biowarfare screening technologies available at the time were unreliable due to a lack of sensitivity and specificity. As a result, the Company expects the U.S. Government decision may negatively impact sales of competitive products and lead to broad market adoption of the Company's RAMP Anthrax Test, the world's only rapid and reliable on-site detection system capable of distinguishing between a hoax and a potentially infectious dose of anthrax.
"Competing rapid on-site tests are widely recognized as unreliable because they cannot detect low levels of anthrax spores and often produce false positive results. However, the inability to quickly obtain a reliable on-site test result when confronting a hoax or potentially infectious dose of anthrax is unacceptable for America's 2,000,000 emergency responders who don't have the option of waiting one-to-three days for a confirmatory lab test before they take action," says Mr. Bill Radvak, President and CEO. "Independent scientific evaluation has unequivocally shown the RAMP Anthrax Test reliably detects anthrax spores with a level of sensitivity that is unprecedented. The test is also not affected by non-anthrax hoax powders and shows very low cross reactivity with related bacillus species. After the recent high profile criticism of competing tests on the market, we expect the RAMP System will soon become the industry leader in on-site biowarfare detection."
Independent validation from a leading U.S. government laboratory confirmed the Company's RAMP Anthrax Test demonstrated a reliable detection level of 4,000 live spores, with 99.9% confidence in specificity, and no false positives - substantially below the 10,000 spore level used by the CDC to define an infectious dose. No other competitive technology purports to have comparable performance characteristics.
On May 29, 2002, Response Biomedical announced the commercial launch of the RAMP Anthrax Test. The battery operated RAMP Reader weighs less than five pounds and is easy to operate with single-use disposable cartridges. Data can be stored on the device and uploaded to a printer or computer. The system is available for an all-inclusive price of less than US$10,000.
Earlier this year, the RAMP Reader received marketing clearance from the U.S. Food and Drug Administration (FDA) for general clinical use. The biowarfare detection segment is an unregulated industry, and the Company has publicly articulated its support for FDA intervention to address misinformation and confusion in the marketplace.
The Company has also initiated the development of additional tests for biological agents including botulinum toxin and ricin to meet the security and business requirements of corporations, governments and public safety institutions worldwide. The Company expects RAMP will become an essential emergency device analogous to a standard fire extinguisher - not often used but readily available.
About Response Biomedical Corp.
Response Biomedical develops rapid on-site diagnostic tests for use with its proprietary RAMP Reader intended for both clinical and environmental applications, including tests for the detection of heart attack and biological agents beginning with anthrax.
The RAMP System is a platform technology that delivers accurate and reliable on-site test results in less than fifteen minutes. It consists of a portable fluorescence reader and disposable test cartridges, with the potential to be adapted to more than 250 medical and non-medical tests currently performed in laboratories. Additional assays under development include tests for the diagnosis and/or monitoring of prostate cancer, therapeutic drugs and environmental agents including botulism toxin and ricin.
On June 11, 2002, the Company received marketing clearance in Canada for the Myoglobin Assay System. On January 8, 2002, the Company announced the U.S. Food and Drug Administration provided marketing clearance for Response Biomedical's RAMP Reader for general clinical use, as well as the Myoglobin test - a cardiac marker used in the early diagnosis of heart attack. |
