By Frances Bishopp

International Murex Technologies Corp. and Innogenetics NV, have completed evaluation trials of a HIV-1 Reverse Transcriptase (RT) monitoring test that simultaneously detects wild-type and HIV mutations associated with AZT, ddI, ddC and 3TC, a group of drugs currently used separately and in combination to treat HIV patients.

According to researchers involved in the trials, the Murex/Innogenetics LiPA HIV-1 RT assay accurately determined wild-type or mutant genotypes with high specificity in more than 98 percent of the tested samples.

The Murex/Innogenetics LiPA HIV-1 RT test, which was developed by Innogenetics, of Belgium, uses proprietary multiple probe DNA technology on a novel coated membrane system and simultaneously analyzes multiple areas of the HIV gene.

Innogenetics' INNO-LiPA technology allows the simultaneous use of multiple DNA testing on one patient sample, Catherine Bardwick, consultant for International Murex, of Toronto, told BioWorld Today. "This is very leading edge technology for DNA probes," Bardwick said.

Under terms of a 15-year contract, Innogenetics provides International Murex with the rights to the test and International Murex pays Innogenetics a yearly fee based on revenue. These funds are partially reinvested in research and development that International Murex directs, Bardwick said.

"This test allows the doctor to discover any resistance to various drugs the patient might be developing," Bardwick explained. "Sometimes, people have a natural resistance to AZT or other drugs, so to start them on it or other drugs would be useless."

The HIV-1 RT test increases speed of testing, decreases costs, in that patients wouldn't take unnecessary drugs and improves sensitivity and specificity. "The test can be run at any time, in fact, clinicians are recommending that a benchmark test be done before starting or changing therapy, and then done as therapy continues to detect mutant strains which will tell them if resistance has started to develop," Bardwick said.

International Murex has not applied for FDA approval yet, Bardwick said, but, the company hopes to launch the product by April or May of this year. *

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