Bayer hope to develop assays that will enable healthcare professionals to optimise healthcare delivery by better predicting an individual's genetic likelihood for disease onset, and maximising disease treatment success by matching a person's unique genetic make-up to the therapy.
Pharmacogenomic assays or 'personalised medicine' are considered by many to be the next step in the evolution of pharmaceutical treatment and therapy. Pharmacogenetics is the study of how someone's genetic make-up determines how well a medicine works in his or her body, as well as what side effects are likely to occur.
Genomics-based, molecular diagnostic profiling is one of the key tools for making personalised medicine a reality. Pharmacogenetics research is set to provide information to eventually guide healthcare professionals in getting medicine to a person that is tailored to the individual.
The license agreement stems from the DxS and BTG decision to allow Bayer full use of their Amplification Refractory Mutation System (ARMS) DNA diagnostic technology that assists in the development of pharmacogenetic assays.
Amplification Refractory Mutation System technology, as licensed from DxS and BTG, is a method for the detection of genetic variations and single nucleotide polymorphisms (SNPs). SNPs are variations in a DNA sequence that occur when a single nucleotide (A, T, C or G) in the sequence is altered.
ARMS technology has applications throughout this market such as the detection of genetic variations in the genes responsible for common diseases, including cancer and heart disease.
"Clinical diagnostics is evolving from assays and platforms that diagnose and monitor disease to genomics-based assays that can not only help determine an individual's propensity to develop a disease but also can be used to select the correct therapeutic regimen for patients on an individualised basis," said John Blackwood, vice president global new business development, with Bayer Diagnostics.
"The advent of pharmacogenetics and the increased use of molecular diagnostics as a primary tool for the diagnostician will shift healthcare to a more efficient, more cost effective system that ultimately provides enhanced care at the individual level," he added.
Although more than 99 per cent of human DNA sequences are the same across the population, variations in DNA sequence can have a major impact on how humans respond to disease; environmental challenges such as bacteria, viruses, toxins, and chemicals; and drugs and other therapies.
Scientists believe SNP maps will help them identify the multiple genes associated with such complex diseases as cancer, diabetes, and vascular disease. In addition, SNPs can help determine the likelihood that someone will develop a particular disease.
Furthermore, SNPs are useful in predetermining an individual's response to drug treatment, and can be used as markers to differentiate individuals with varying response to treatment.
Pharmacogenomics is part of a $1.9 billion nucleic acid diagnostic market, which also includes testing for infectious and genetic diseases, as well as cell/tissue typing, cancer genetics and personalised medicine.
It is the fastest growing sector of the diagnostic marketplace, increasing at a rate of 20-40 per cent per annum. This could, according to some industry experts, create a potential $8-10 billion market segment by 2010.