By Kim Coghill
Washington Editor
By the middle of November, Visible Genetics Inc. will begin selling the worlds first HIV test kit designed to analyze genetic information so doctors can prescribe individual drug therapies.
In a conference call Thursday, Visible Genetics Inc., a pharmacogenomics company located in Toronto, said the FDA gave it clearance to market its TruGene HIV-1 Genotyping Kit and OpenGene DNA Sequencing System. The three-part kit, Visible Genetics first FDA approval, is considered a major advancement in the treatment of AIDS patients. It already is approved in France, Canada and Argentina.
In the AIDS community, measurement of viral resistance as a guidance in terms of cocktail therapy has been shown to improve patient outcome, Fariba Ghodsian, managing director of health care research at Roth Capital Partners Inc. in Los Angeles, told BioWorld Today. Right now, labs use home-brew kits and the feeling is once there is an FDA-approved product, it will have widespread use.
The kit works by genetically decoding the highly mutagenic HIV-1 from patient serum, then identifying mutations in the virus by comparing the genome to a control, and finally indicating a personalized treatment regimen.
The kits will sell for $225 apiece and at peak should generate about $200 million to $300 million worldwide for the company, Ghodsian said. Visible Genetics sales team of 40 people will market the TruGene.
Visible Genetics stock (NASDAQ:VGIN) closed Thursday at $18.668, down 57 cents.
Richard Daly, Visible Genetics CEO, told conference call listeners, This is the first time the FDA has been asked to look at and has cleared for sale any product that is based on sequencing technology, and that is important. This technology is going to be the basis for a pipeline of products which has real potential to change the way physicians are able to direct therapy to specific individual patients and illnesses.
Visible Genetics fundamental strategy is to provide technology and a platform that uses sequencing in the treatment of a specific illness, Daly said. HIV is the first test to run on that platform, but our strategy has been for some time to have multiple tests running across the same platform. Upcoming in the first half of 2002, we anticipate the North American launch of our hepatitis B and C products [for the research market] and in the second half of 2002 the launch of our first oncology products [also for research]. These products all have the same fundamental function behind them, he said.
The company submitted the TruGene HIV-1 Genotyping Kit and OpenGene System to the FDA last September as an integrated system to the chemistry, hardware, software and interpretive patient report. The submission was based on a 541-patient study that showed a benefit to HIV-1 patients who received the testing as compared to patients who received standard-of-care treatment. The study showed that 36 percent of patients who received genotype testing experienced viral suppression as compared to 27 percent of the patients receiving standard treatment. (See BioWorld Today, Sept. 6, 2000.)
The OpenGene system employs patented CLIP technology a single-step, bidirectional sequencing method that reduces the time and cost of identifying genetic information.
Approval of the TruGene and OpenGene systems also is significant in that it establishes these products as the predicate device in HIV genotypic resistance and testing, and thus all future devices will have to demonstrate equivalence to this system, the company said.
So far, Celera Diagnostics, a joint venture of Applied Biosystems and Celera Genomics, has filed for FDA approval of ViroSeq HIV-1 Genotyping System as an in vitro diagnostics kit.