Toronto-based Tm Bioscience last week launched its Tag-It CYP450-2D6 mutation detection kit — within days after Roche officially introduced its Affymetrix-platform diagnostic CYP450 GeneChip tests to great fanfare in the mainstream media.
“This [P450-2D6] is a rapidly growing test market for the pharmaceutical and the clinical sectors,” said Jeremy Bridge-Cook, Tm Bioscience vice president for business development. He told BioArray News that Tm is looking to compete with Roche and other test-makers on the basis of cost and efficiency.
Company officials told BioArray News that the timing of this launch so close to the Roche-Affymetrix offering was coincidental, but that Tm Bioscience was delighted that a product launch a year in the planning should arrive in such an environment.
The company last week closed a CA $5.1 million private placement and obtained a non-exclusive license for cystic fibrosis gene mutation patents owned by the Hospital for Sick Children of Toronto and the University of Michigan, in a preliminary step to producing its next kit, a cystic fibrosis test that is planned for rollout before the end of the year.
This 2D6 mutation detection product is the company’s second Tag-It product overall. The product does batch analysis in a 96-well plate, analyzing 13 mutations in one well. It will identify patients lacking one or both copies of the gene, and those with more than two copies of the gene.
A mutation or the absence of both genes can result in decreased drug metabolism and a risk of adverse drug reactions. Conversely, duplication of the gene can cause rapid metabolism, rendering ineffective drugs given at commonly used dosages. This ability to discern drug metabolism is a pioneering step on the road to the drug industry’s holy grail of personalized medicine.
The 10-year-old company is focused on applying its universal array technology to genetic testing. The Tag-It assay system is engineered in a universal configuration consisting of 100 separate oligonucleotide pairs of tag and anti-tag- primers. The tags are each attached to a probe, and the anti-tags are each fixed to a fluorescent bead, provided by Tm’s partner, Luminex. Tm seeks to sell into an installed base of 1,400 Luminex systems in clinical reference labs, or clinical research organizations.
The company introduced the Tag-it Mutation Detection Kit, of which the test is an application, last December. The company’s first offering was a coagulation testing product for Factor V Leiden, Factor II (prothrombin) and the two most common mutations in the MTHFR gene.
The company plans to sell the 2D6 tests to distributors at an average price of CA $40 ($30), of which 50 percent is margin. Distributors will likely sell the test at CA $70 ($52).
In news reports last week, Roche said it would sell its Amplichip CYP450 at $350-$400 and expects sales of $100 million by 2008. The Amplichip queries the CYP2D6 and CYP2C19 genes and probes for more than 30 polymorphisms in the CYP2D6 area, and two in CYP2C19.
Gearing Up for Production
Tm Bioscience’s Toronto manufacturing facility is undergoing regulatory inspection for ISO 1345 certification. The facility can produce 400,000 tests per year, and can ramp up to production of 2.7 million tests a year, said company spokesman James Smith. The company will sell the Tag-It as a research-use-only product or as an analyte-specific reagent.