By Randall Osborne

West Coast Editor

Having just launched its pharmacogenomic HIV test, Visible Genetics Inc. raised $22 million in a private placement of 2,637,890 shares at $8.34 per share. The price is a 16 percent discount to the average closing price for 10 days before the offering closed.

Bruno Maruzzo, director of investor relations for Toronto-based Visible Genetics, said the money will be used for general corporate purposes.

¿Based on our current projections, we¿d probably run out of money by the end of 2002,¿ he told BioWorld Today. ¿It depends on how well sales go, but we feel this is all the money we need now.¿

In September, the FDA cleared the company to market its Trugene HIV-1 Genotyping Kit and OpenGene DNA Sequencing System, a three-part kit that had been approved earlier in France, Canada and Argentina. The test genetically decodes HIV-1 from patient serum and identifies viral mutations by comparing the genome to a control, thereby pointing to a personalized treatment regimen. (See BioWorld Today, Sept. 28, 2001.)

¿We¿ve upgraded all of our existing customer sites to FDA-approved software, but we don¿t expect big sales to start until the first quarter of 2002,¿ Maruzzo said.

Trugene refers to the reagents, and OpenGene includes the hardware and software in the HIV kit, Maruzzo said. The company has similar products for hepatitis C and hepatitis B. ¿We¿re currently selling them in Europe for research, and plan on introducing HCV in the U.S. next year, and then HBV, again for research purposes initially,¿ Maruzzo said.

Joel Goodman, chief scientific officer for Dallas-based Dynacare Inc., said the company had been ¿running [the Trugene HIV test] for three or four months without FDA clearance; you can do that if you stipulate it¿s for investigational use only. Doctors love it.¿

Goodman called the test ¿absolutely mandatory¿ for HIV patients. ¿To put them on a drug cocktail without knowing what you¿re trying to kill is just not right anymore,¿ he told BioWorld Today.

This month, Dynacare began offering the Trugene HIV test through its network of regional laboratory operations in 21 states. ¿In lieu of having a cure, you want to minimize the effects,¿ said Judi Ottmann, associate vice president of marketing for Dynacare.

¿There are ways to [minimize effects of the disease] with the right drugs, but you need to know what the right mix would be,¿ Ottmann said. ¿Everybody¿s HIV infection is different. Those mutations have a different response to different kinds of drug therapy, and if you first understand what type of mutation has taken place, you can be advised what type of drug cocktail would be most effective.¿

Dynacare, the third largest provider of lab services in North America, operates 22 central labs, including Dynagene, its center for genetic and esoteric testing and counseling, plus 63 rapid response labs and 173 patient service centers. ¿We¿re using it with our physician clients, who would order the tests for their patients affected with HIV,¿ Ottmann said. ¿It¿s important to start that therapy as soon as the patient is diagnosed. You want to immediately run a test like this, so you know exactly what you¿re dealing with.¿

Other applications may be on the horizon. Earlier this month, at the 41st meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy, Visible Genetics offered data suggesting Trugene can be used to detect HIV drug resistance even when only very low levels of the virus are present in a patient¿s blood.

Ottmann told BioWorld Today she wasn¿t sure how many orders Visible Genetics might expect through Dynacare for the HIV test, the first pharmacogenomics test approved by the FDA.

¿It¿s something we¿re just rolling out in the last several months,¿ she said, noting that Dynacare began working with Visible Genetics about six months ago, before the company won the regulatory go-ahead. ¿We were kind of building a market for it,¿ she added. Visible Genetics¿ 40-person sales team will be marketing the test.

The company submitted Trugene to the FDA last year, along with data from a 541-patient study showing 36 percent of patients who received genotype testing experienced viral suppression in their treatment, as compared to 27 percent of the patients receiving standard treatment without testing. (See BioWorld Today, Sept. 6, 2000.)

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