The increasingly crowded CYP450-testing market has one more occupant Hartford, Conn.-based Genomas' Hilomet PhysioType. Although the test is not unique, the company hopes it will sell enough to support the release of at least two more genotyping tests in another of Genomas' core areas, nutritional genomics.
The test is valuable to Genomas as "an early revenue stream" that "gives us the experience we need as we introduce the more proprietary PhysioType systems that we're developing," Robert Scherrer, Genomas' CFO, told Pharmacogenomics Reporter.
Like its famous US Food and Drug Administration-cleared predecessor, Roche's CYP450 AmpliChip, the PhysioType test interrogates both the 2D6 and 2C19 P450 genes, which both Roche and Genomas advertise as important factors for predicting response to ADHD drugs and antidepressants.
Unlike AmpliChip, PhysioType also genotypes the 2C9 gene, which is useful for helping to predict patient response to the popular cardiovascular drug warfarin, and Genomas is marketing it for that purpose. The other major gene known to be important to warfarin response, VKORC, is not interrogated by the test.
Clinical Laboratory Partners, a Connecticut-based clinical reference lab, has agreed to distribute the PhysioType test, Genomas said last week.
In the first quarter of next year, the company hopes to launch the AeroFit assay, which is "designed to predict the effect of exercise on metabolic syndrome and cholesterol" based on a genetic signature, Scherrer said. Ideally, the test's results will tell doctors how much exercise a metabolic patient needs, or whether exercise will even prove to be a useful treatment to reduce, he said. The test predicts the effect of exercise on several factors, "from cholesterol to metabolic fitness, to triglycerides, to LDL," Scherrer added.
All of Genomas' products are targeted to physicians, but initially, the company hopes to sell directly to patients, Scherrer said.
In addition to the PhysioType test, the company is working on drug safety diagnostics for drug-induced metabolic syndrome and statin-induced muscle injury, Scherrer said. Along with Aerofit, Genomas is working on another "lifestyle" test called Hilocarb, which is intended to predict the effect of diet on the treatment of metabolic syndrome, he said. These three products are slated for launch "in the second half of next year," but the company has not decided whether to file for FDA clearance with any of its products, Scherrer added.
Gualberto Ruaño, a founder, former president, CEO, and chief scientific officer of Genaissance, launched Genomas in 2003 to study individual genetic responses to stress, exercise, climate, and disease.
Chris Womack ([email protected])