By Matthew Willett

Visible Genetics Inc. is gearing up to market the Trugene HIV-1 Genotyping Kit and OpenGene DNA sequencing system, having submitted results from a series of the pharmacogenomic analysis system's tests to the FDA for 501(k) approval.

The three-part kit is designed to genetically decode the highly mutagenic HIV-1 from patient serum, identify mutations in the virus by comparing the genome to a control and then indicate a personalized treatment regimen.

Pharmacogenomic analysis shows promise as a tailor for individualized therapies, and as the process becomes more widely recognized and further researched, VGI stands poised to lead the industry with the approval-pending kit, analysts said Tuesday.

Robertson Stephens analyst Michael King rated the company a "buy" in a report Tuesday. He cited the FDA submission and the company's prime position at the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, to be held in VGI's hometown of Toronto later this month. The investment bank called the company "an exciting story in the explosive genotypic resistance testing market."

The FDA now has 90 days to respond to the submission on the kit, which VGI CEO Richard Daly estimated could service a market of up to 600,000 units annually.

"It's been a huge amount of work over a number of years," Daly told BioWorld Today. "There are three parts to the submission: the chemistry, the instrument and the software. This is one of the first times a software package has been an integral part of the entire package, and the FDA regards the software element much as a drug, so that's what makes this an unusually complex submission."

Daly said, however, that the company's 35-person sales force is gearing up for the launch.

"The data are very strong, and though it's still complex, I have no doubt that if the FDA has questions they'll get back to us within the 90-day period," he said.

The submission comes after a long period of testing for the genotyping kit. Most recently, the company used Trugene in a 541-patient study that showed a benefit to HIV-1 patients who received drug-resistance genotype testing over patients who received standard-of-care treatment.

Of the patients in that study, which VGI later said confirmed the kit's functionality, 36 percent of patients who received genotype testing experienced viral suppression, as compared to 27 percent of patients who received standard treatment.

The FDA stopped a 1999 trial of the kit when preliminary data demonstrated the clinical utility of HIV genotyping in treatment of HIV-infected patients.

Daly said the kit's utility is rooted in the virus' high mutagenicity. His company's genotyping efforts are designed to identify mutation-caused drug resistances, giving doctors a better chance of creating effective therapeutic drug combinations.

"The virus replicates about 1 billion times per day in a patient, and on average there's one error per replication, so as soon as you apply a drug pressure on the virus it mutates. After a couple of years the drugs begin to lose efficacy," Daly said.

Therapies, then, developed in the mid-1990s, have begun in many patients to lose efficacy, he said. Genotyping the patient's mutated strain of HIV-1 is designed to tailor drug therapies to patient needs.

"It's taken those five years to develop the technology of genotyping and sequencing the virus and finding combinations of drugs that are most effective," he said. "This represents a major advancement in treatment, specially tailoring to individual patients a specific therapy that will be the most efficient for that patient."

The pharmacogenomic approach shows enough promise for market experts to call it a landmark for VGI.

"Clinical studies to date have proved initial proof-of-principle that the use of genotyping along with state-of-the-art HIV drug therapy not only results in improved patient outcomes, but is cost effective as well," King said. "We believe HIV genotyping represents a worldwide market opportunity of $250 million to $500 million based upon the success of Hoffmann-La Roche's Amplicor Viral Load assay, which is used more than 2 million times per year in North America."

VGI is allied with Roche, of Nutley, N.J., for European distribution.

Future opportunities for the company include hepatitis B and C platforms for the kit, for which trials are under way.

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