TARRYTOWN, N.Y., and LONDON, June 28 /PRNewswire/ -- Bayer HealthCare, Diagnostics Division, a member of the Bayer Group announced today that it has entered into a license agreement with DxS and BTG. Bayer Diagnostics licensed the companies' proprietary Amplification Refractory Mutation System(TM) (ARMS) DNA diagnostic technology for the ability to develop diagnostic assays, including pharmacogenetic assays. Certain assays to be developed by Bayer will enable healthcare professionals to optimize healthcare delivery by better predicting an individual's genetic likelihood for disease onset, and maximizing disease treatment success by matching a person's unique genetic make-up to the therapy.
"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 individualized basis," stated John Blackwood, Vice President Global New Business Development, with Bayer HealthCare's Diagnostics Division. "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."
Personalized Medicine and "SNPs"
Pharmacogenetics is the study of how an individual will respond to particular medical treatments based on personal genetic profile. The goal of pharmacogenetics is to understand 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. Advances gleaned from pharmacogenetics research will provide information to guide healthcare professionals in getting just enough of the right medicine to a person -- the practice of "personalized medicine."(1)
Genomics-based, molecular diagnostic profiling is one of the key tools for making personalized medicine a reality. Amplification Refractory Mutation System technology, as licensed from DxS and BTG, is a well-established and reliable 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.(2)
Although more than 99 percent 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.(2)
Dr. Stephen Little, Chief Executive Officer of DxS commented, "The information generated by genotyping is key for the discovery and development of new diagnostics and we are pleased that Bayer Diagnostics has selected ARMS technology. ARMS has proven results with greater accuracy and speed than competing technologies and is an invaluable tool in the field of diagnostics."
"The addition of Bayer Diagnostics to our growing roster of clients demonstrates the value of ARMS technology and validates the future direction of healthcare is headed towards personalized medicine," commented Martin Sandford, Senior Vice President, BTG plc.
The $1.9 billion nucleic acid diagnostic market 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 percent per annum. This could, according to some industry experts, create a potential $8-10 billion market segment by 2010. ARMS(TM) 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.(3)
(1) http://www.dartmouth.edu/
(2) HumanGenome Project Information Website, http://www.ornl.gov/
(3) CHI Reports, "Molecular Diagnostics: Technological Advances fueling
market expansion." Oct 2003
About DxS
DxS is an established genotyping services company providing pharmaceutical, biotechnology and clinical research companies with rapid and reliable pharmacogenetic analysis to support drug discovery, clinical development and personalized medicine. DxS operates from purpose built laboratories equipped with fully automated sample handling and genotyping systems in Manchester, UK. The Company has implemented industry-leading laboratory management systems and quality control practices.
The DxS service is based on proprietary Scorpions(TM) technology that allows rapid and reliable PCR-based genotyping, and on SAFEspot(TM), a card- based sample collection system that greatly simplifies the storage and transport of blood spots. Scorpions(TM) technology is also licensed to oligonucleotide suppliers and diagnostic companies. For more information on DxS, please visit http://www.dxsgenotyping.com/ .
About ARMS(TM)
ARMS(TM) (Amplification Refractory Mutation System) is a simple, reliable and widely used method for the detection of gene mutations and single nucleotide polymorphisms. ARMS(TM) technology has applications the detection of genetic variations in the genes responsible for common diseases, including cancer and heart disease. ARMS(TM) can also be used in personalized medicine tests, to predict which individuals will respond well to a medicine, and typing infectious pathogens.
About BTG
BTG acquires rights to early stage drugs & other medical technologies from a global network of corporations, universities & research institutions. We apply technical & commercial resources including finance, intellectual property & project management skills to fund & manage outsourced preclinical & clinical development programmes. We then license the technologies to biotech & pharmaceutical companies, which complete clinical & regulatory development & market the approved products. Our pipeline comprises around 50 assets at varying stages of development, contributing to an increasing range of marketed products. Further information on BTG can be found at http://www.btgplc.com/ .
About Bayer HealthCare, Diagnostics Division
Bayer HealthCare, Diagnostics Division ( http://www.bayerdiag.com/ ), based in Tarrytown, New York, U.S.A., is one of the largest diagnostic businesses in the world. The organization supports customers in 100 countries through an extensive portfolio of laboratory testing, molecular testing and near patient care diagnostics systems and services for use in the assessment and management of health, including the areas of cardiovascular and kidney disease, oncology, virology and women's health. Bayer HealthCare Diagnostics Division's global headquarters in the United States operates as part of Bayer HealthCare LLC, a member of the worldwide Bayer HealthCare group.
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Website: http://www.bayerdiag.com
http://www.btgplc.com
http://www.dxsgenotyping.com