Tm Bioscience rolls out drug metabolism genetic test kit
One of the problems frequently encountered in drug development is how to predict the behaviour of a compound to be given in a human clinical trial. Disposition data can be gleaned from pre-clinical studies or single-dose administration in healthy volunteers - dubbed as ’ADME’ studies - but this still leaves issues unresolved such as individual variation, the effect of food, interactions with other medication or changes in drug metabolism with sickness or old age or during recovery from the effects of anaesthetics used in surgery.
Pharma development companies have taken big strides to identify those patients likely to be predisposed to a drug’s side-effects while regulatory agencies increasingly demand enhanced drug safety data in order to minimise adverse reactions in the population.
Now a team of Toronto boffins working at Tm Bioscience have come up with an elegant test-kit that will put a handle on spotting individuals with unusual or ’atypical’ metabolism profiles that could help to avoid the problem -- or at least minimise the risk of needing specialist care because of unwanted or unpredicted adverse reactions.
Known as the Tag-It™ Mutation Detection Kit, for P450-2D6, this genetic test kit will be used so as to identify the presence or absence of important mutations common in patients with atypical drug metabolism. The Tag-It™ P450-2D6 test will equip diagnostic laboratories and drug developers with a system that is both cost-effective and accurate, meeting the escalating growth in demand for drug metabolism testing.
Greg Hines, the CEO of Tm Bioscience, delighted his company is at the forefront of this branch of biomedical research explains: "Our test is a highly accurate and comprehensive test for P450-2D6 genetic markers. This test is the promise of personalised medicine."
Many common prescription and over-the-counter medicines are affected by P450 enzymes. About 20% of currently available prescription drugs are metabolised by P450-2D6 derived enzymes. Hospital care for adverse drug reactions is the third leading cause of emergency room admissions in the United States.
Hines recognises the importance of keeping costs low for users. "The huge market potential for drug metabolism testing will only be realized if tests are marketed at a price that healthcare providers can afford to pay."
"Tm’s P450 tests will be priced in alignment with International cost containment initiatives."
"The format of the Tag-It™ platform allows this test to be sold to the customer at a fraction of the cost of recently announced competitive products," Hines adds.
Tm Bioscience expects to begin shipping the product by the next quarter (Q3) and already has a development and supply agreement with a US customer for the product.
Two more kits are in the Tm development pipeline for late 2003 - early 2004 roll-out : Tag-It™ Mutation Detection Kits for P450-2C9 and the Tag-It™ Mutation Detection Kits for P450-2C19 - these will test for mutations linked to atypical metabolism for a range of common prescription and over the counter medications.
Keywords : Tm Bioscience Toronto, Ontario, Canada Drug disposition, metabolism PK ADME Adverse reaction event Regulatory Individual variation Variability Genetic testing Cytochrome P450 Tag-It™ Mutation detection kit
