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<h1>Pharmacogenomic and Personalised Medicine News</h1>
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<TD width="445" vAlign="top" background="#Biotechnology"><STRONG><A href="#Biotechnology">DxS receives Biotechnology Award for Cancer product from BioNow.</A></STRONG><strong><A href="#DNA">Research project aims to assess correlation between circulating DNA and primary tumours.</A></strong><A href="#T790M"><strong>Improving the detection of T790M mutations on the EGFR gene DxS launch latest oncogene mutation test kit.</strong></A><strong><A href="#egfr_mutation">Superior performance of EGFR Mutation Test Kit creates scope for blood-based prediction of drug response in lung cancer.</A></strong><A href="#egfr_mutation"> </A><A href="#btg_licence"><strong>Extension granted to DxS and BTG for ARMS Technology <BR>
licence parameters. </strong></A>
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<TD vAlign="top"><A href="#Cepheid"><strong>DxS grants human IVD extension of Scorpions license to Cepheid</strong></A><strong><A href="#EGFR_gene">Detecting mutations in the EGFR gene with a new level of sensitivity and specificity</A></strong><A href="#personalised_medicine"><strong>Tapping into the Promise of Personalised Medicine - DxS launches new bespoke consultancy and training service</strong></A><strong><A href="#uk_biobank">UK Biobank invests in DxS's genetic expertise </A></strong><strong><A href="#cepheid_scorpions">Cepheid Licenses DxS Scorpions™ Technology</A></strong><strong><A href="#bayer_genotyping">Bayer HealthCare Diagnostics Division Announces Genotyping License Agreement with DxS and BTG</A></strong><A href="#tumour_mutation_analysis"><strong>AstraZeneca presents data on the application of DxS' ARMS™ / Scorpions™ EGFR assay for tumour mutation analysis</strong></A><strong><A href="#UGT1A1*28">DxS launches novel pharmacogenomic assay for UGT1A1*28</A></strong><strong><A href="#PCR_patents">Expiry of PCR patents opens US market for new DNA detection systems</A></strong><A href="#FDA_pharmacogenomic"><strong>DxS welcomes launch of FDA Pharmacogenomic Guidelines</strong></A><A href="#CTCLS"><strong>DxS Appoints CTCLS as Japanese Agent for its Genotyping Services</strong></A>
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<p><strong>Archive News</strong></p>
<p><STRONG><a href="news_arch.htm">View press releases from previous years</a></STRONG></p>
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<p><STRONG>DxS receives Biotechnology Award for Cancer product from BioNow </STRONG></p>
<p>Manchester, UK (28th November 2006) – DxS has won a coveted ‘Biotechnology Project of the Year’ award for its highly sensitive EGFR (Epidermal Growth Factor Receptor) Mutation Test Kit. Sponsored by the Manchester based law firm Pannone LLP, the award was presented by Bionow, the Northwest Regional Development Agency’s (NWDA) biotechnology cluster support group, at the agency’s annual awards ceremony in Cheshire, UK. The award scheme aims to showcases the very best of biotechnology in the region, which is home to some of the UK’s most innovative biomedical companies.</p>
<p>Recent advances in the field of cancer drugs have provided DxS with an opportunity to use its scientific and commercial strengths to develop the world’s first tumour mutation analysis kit to identify patients who will respond well to certain lung cancer therapies. This new oncogene assay can detect the 29 most common somatic mutations in the Epidermal Growth Factor Receptor Gene, identifying mutations that are not visible by sequencing techniques.</p>
<p>Commenting on the receipt of the award Dr Stephen Little, CEO of DxS said, “We are delighted to receive this award as it acknowledges the hard work that has gone into developing such a ground-breaking technology. DxS has created a novel clinically valuable diagnostic kit that offers un-rivalled sensitivity and selectivity over previous methods.” </p>
<p>Simon Wallwork, Corporate Partner at Pannone LLP adds, “We are pleased to be able to support the innovative work of North West based biotechnology companies, such as DxS. With a biotech client base of over 20 companies, Pannone’s understand the work involved in commercialising a scientific idea into a successful product”. Pannone LLP is a Manchester based legal firm with a dedicated Life Science division.</p>
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<p><strong>Research project aims to assess correlation between circulating DNA and primary tumours</strong></p>
<p><strong>AstraZeneca and The University of Manchester work with DxS on a new Clinical Pharmacology Collaboration.</strong><BR>
</p>
<p><strong>Manchester, UK (7th August 2006)</strong> - DxS has been selected by AstraZeneca PLC and The University of Manchester (Paterson Institute) to welcome a Clinical Research Fellow supported by AstraZeneca and Cancer Research UK during part of a project, aiming to identify circulating DNA tumour markers in patients' blood. </p>
<p>DxS, a personalised medicine company, will assist the research fellow in the development of mutation detection assays using its Scorpions™ and ARMS™ Technologies. These offer highly selective tests that show significant improvement in detection of low-level mutations over traditional sequencing-based techniques. The assays can detect mutations in circulating DNA in blood, which is essential to allow the determination of the molecular profile of a tumour through methods other than an invasive biopsy. </p>
<p>The initial focus of the three year project will be to develop assays for genes which show prevalent mutations in cancer. </p>
<p>Dr Andrew Hughes, Director of Discovery Medicine at AstraZeneca with Professor Caroline Dive, Clinical & Experimental Pharmacology, Paterson Institute comment, "With their expertise in ARMS allele specific PCR and their proven capability in the development of oncology mutation tests, DxS was a natural choice for a partner in this key diagnostic project looking at the identification of blood borne biomarkers for mechanism-based therapies."</p>
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<p><strong>Improving the detection of T790M mutations on the EGFR gene DxS launch latest oncogene mutation test kit.</strong><BR>
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<p><strong>Manchester, UK (25th July 2006)</strong> - Lung cancer patients who have acquired gene mutations associated with resistance to tyrosine kinase inhibitors such as Iressa or Tarceva (1) can be identified far more accurately using a new mutation test kit from DxS.</p>
<p>Designed to detect the T790M mutation in exon 20 of the epidermal growth factor receptor (EGFR) gene, the new assay will allow drug developers to investigate its reported association with acquired resistance and can act as a useful tool to predict drug response. Its launch comes at a time when drug developers are moving away from cytotoxic therapies to more targeted, gene-based approaches to cancer treatment.</p>
<p>By harnessing the sensitivity of DxS's ARMS™ allele-specific PCR and its Scorpions™ quantitative real-time signalling system, the new assay can detect mutant copies even if they represent as little as 1% of the sample. This is a marked improvement in sensitivity over traditional sequencing-based techniques that lack discrimination when there are high levels of background DNA. The new assay performs equally well using DNA extracted from various samples, such as paraffin embedded tumours and blood.</p>
<p>Intended as a research tool, the T790M quantitative mutation assay detects the presence of a mutant thymidine base in a background of normal cytosine bases at position 2369 of the EGFR gene. It is presented as two real-time PCR assays: one detects the mutant base the other acts as a control by quantifying the EGFR gene. Results are semi-quantitative and provide an approximate determination of the percentage of mutant T790M in the sample.</p>
<p>DxS are presenting an abstract on "Sensitive and Selective Assays for Mutations in EGFR" on Wednesday 27th July, 9.30am at the AACC Clinical Lab Expo in Chicago, IL. Please visit DxS at exhibition booth number 2272 for further information about the T790M mutation kit.</p>
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<p><strong>Superior performance of EGFR Mutation Test Kit creates scope for blood-based prediction of drug response in lung cancer</strong>. <BR>
<strong><BR>
Paper in Clinical Cancer Research could lead to less invasive testing</strong> <BR>
</p>
<p><strong>Manchester, UK (11 July 2006)</strong> - A paper1 published this week in Clinical Cancer Research indicates that testing DNA isolated from blood, rather than tumour tissue, could be the way forward for predicting responses to Gefitinib (Iressa), Erlotinib (Tarceva) and other cancer therapies. This is a far less invasive sample than the current practice of obtaining a tumour biopsy from patients with lung cancer.</p>
<p>Previously, tumour biopsies have been used, as it has been difficult to detect the low levels of specific mutations shed from the tumour into the blood against the high background of normal DNA. However, the exceptional sensitivity afforded by DxS' Epidermal Growth Factor Receptor (EGFR) Mutation Test kit allowed the National Cancer Centre in Tokyo to reliably measure mutations in serum and use these as a predictor of response to Gefitinib (Iressa).</p>
<p>The DxS EGFR Mutation Test Kit is a molecular assay combining ARMS (allele specific PCR) and Scorpions™, a rapid fluorescent signaling system. </p>
<p>In addition to heralding the introduction of blood-based mutation detection, the paper also concluded that patients who were EGFR mutation positive appeared to have better outcomes with Gefitinib treatment in terms of progression-free survival, overall survival and response, than those patients who were EGFR mutation-negative.</p>
<p>Commenting on the publication of the paper, corresponding author Dr Kazuto Nishio said, "The DxS test kit detected mutations that were missed by direct sequencing techniques. We anticipate that the detection of EGFR mutations in serum DNA using the Scorpions ARMS assay will be useful as a feasible approach for predicting tumour response to gefitinib." </p>
<p>DxS has already developed assays for the 26 next most common EGFR mutations which predict both drug response and also drug resistance (T790M). Further oncology mutation kits are in development. </p>
<p>1 Clin Cancer Res 2006; 12(13) July 1, 2006 "Detection of Epidermal Growth Factor Receptor Mutations in Serum as a Predictor of the Response to Gefitinib in Patients with Non-Small-Cell Lung Cancer"<BR>
Hidehaur Kiura, Kazuo Kasahara, Makoto Kawaishi, Hideo Kunitoh, Tomohide Tamura, Brian Holloway and Kazuto Nishio.</p>
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<p><strong>Extension granted to DxS and BTG for ARMS Technology licence parameters </strong><BR>
</p>
<p><strong>London & Manchester, UK (9th January 2006) </strong>- BTG and DxS announce today an extension and improvement to the licences they are able to provide for use of the Amplification Refractory Mutation System (ARMSTM). ARMS is a simple, reliable and widely used method for the detection of gene mutations and single nucleotide polymorphisms. </p>
<p>Under an extension to their licence agreement with AstraZeneca, BTG and DxS are now able to grant licences under the technology rights to ARMS and related technologies from a combination of the licensable rights under both AstraZeneca and City of Hope patents (patent numbers US 5,595,890, US 5,137,806, US 5,639,611 and corresponding patents worldwide). This will be beneficial for the industry as it places the major rights with one licensor.</p>
<p>In March 2004, an agreement was signed with AstraZeneca giving DxS and BTG certain rights to the intellectual property with the aim of further commercialising the technology within the diagnostic and research markets. The extension will allow DxS and BTG to maximise the commercial value for the ARMS™ technology. This is being achieved via companies that offer products and services that relate to the detection of genetic variation, companies that are currently using ARMS™ technology as part of their in-house research activities, as well as encouraging new and novel applications for this powerful technology.</p>
<p>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. </p>
<p>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. </p>
<p>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™ 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.</p>
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<p><strong>DxS grants human IVD extension of Scorpions license to Cepheid</strong><BR>
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<p><strong>Manchester, UK, 30th November 2005</strong> - Cepheid (NASDAQ: CPHD) and DxS Ltd, today announced that it had extended the scope of the Scorpions technology license granted to Cepheid so that it can be used in the human in vitro diagnostic market. </p>
<p>Cepheid originally took a license to DxS' Scorpions technology, which enabled the company to develop a new water testing application within the environmental market. </p>
<p>Commenting on the license extension, John Bishop, Cepheid's Chief Executive Officer states, "Based on our industrial experience we have found Scorpions provided benefits in terms of speed of detection and the ability to develop highly multiplexed tests. As we continue to develop our clinical molecular diagnostic program, we want to enable our scientists to have access to this technology for clinical application as appropriate."</p>
<p>Scorpions™ probes are highly sensitive, sequence-specific, bi-functional molecules containing a PCR primer covalently linked to a probe. Scorpions probes provide strong fluorescent signals, excellent sequence discrimination, short reaction times, and predictable probe design. The interaction of the probe and the desired target occurs very rapidly and in advance of any competing side reactions such as the formation of internal secondary structures or re-annealing. </p>
<p>Commenting on the agreement, Dr. Stephen Little, Chief Executive Officer for DxS, said, "We are delighted to have extended our Scorpions license arrangement with Cepheid, When such a recognised leader in rapid genetic testing, shows this degree of confidence in our nucleic acid detection technology, it confirms that the unique intra-molecular nature of the Scorpions reaction makes it ideal for fast, quantitative, real-time PCR analysis."</p>
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<p><strong>Detecting mutations in the EGFR gene with a new level of sensitivity and specificity</strong><BR>
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<p><strong>16th November 2005, Manchester (UK)</strong> - Low-level tumour mutations and deletions in the Epidermal Growth Factor Receptor (EGFR) gene can now be detected with unrivalled simplicity and sensitivity following the launch by DxS of the first in a range of oncology mutation test kits. </p>
<p>The EGFR Mutation Test Kit combines the specificity of AstraZeneca's ARMS™ (allele specific PCR) technology with the sensitivity of DxS' Scorpions™ signalling system to deliver a quantitative and robust validated test for EGFR mutations in tumour samples. This new approach will be uniquely powerful in the field of somatic mutation detection where it may enable the researcher to avoid lengthy and inefficient tumour enrichment methods.</p>
<p>Current analytical methods of mutation detection focus on DNA sequencing, however their limited sensitivity may fail to detect low-level mutations. By contrast, <BR>
these are readily visible with the new DxS test, since it allows the mutation prevalence in a background of normal sequences to be estimated.</p>
<p>Recently a number of studies have examined EGFR-targeted drugs whose activity has been observed in a subgroup of patients with non-small-cell lung cancer. These studies have identified specific activating mutations within the tyrosine kinase domain of EGFR associated with the dramatic responses to therapy in this subgroup. </p>
<p>In addition to the new EGFR test, DxS offers an in-house analysis service for a panel of oncology tests for the detection of mutations in the other kinase, genes including K-RAS and B-RAF.</p>
<p>Please visit our <strong><A href="products.htm" target="_top">EGFR Mutation Test Kit</A></strong> page.</p>
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<p><strong>Tapping into the Promise of Personalised Medicine<BR>
DxS launches new bespoke consultancy and training service</strong></p>
<p><strong>Manchester, UK, 8th November 2005</strong> - DxS Ltd, a leading personalised medicine company, is taking action to ensure the promise of individualised therapy becomes reality by launching an a new consultancy and training service on pharmacogenomics and its value in delivering safe and effective medicines.</p>
<p>Pharmacogenetics, the study of how genes affect an individual's response to drugs, is now widely recognised as a fundamental development opportunity for the pharmaceutical industry. Only recently (September, 2005), a report by The Royal Society (UK), 'Personalised medicines: hopes and realities', confirmed the positive impact that pharmacogenetics will have on drug development in the future, and predicted that patients should expect to see the fruits of this within 15-20 years. However, DxS believes the time for pharmaceutical companies to start planning for personalised medicine is now. This view is also supported by the regulators, particularly the FDA, who recently released guidance on 'Pharmacogenomic Data Submissions'. </p>
<p>By working with experts within their field at DxS, pharmaceutical and clinical research customers can receive training on pharmacogenomics and personalised medicine, learn how to incorporate genotyping into a clinical trial and understand how to weigh up the various options for its use within Phase I, II and III. Advice on regulatory and ethical aspects, including advice on FDA Pharmacogenomic Data Submissions, and the role of companion diagnostics is also offered. Furthermore, DxS can also provide research and consultancy advice on which specific SNP markers should be used for certain drug targets.</p>
<p>"In launching the new Pharmacogenomic Training Course, Dr Stephen Little, CEO of DxS said, "We have found that many companies are still unsure of the implications and opportunities that pharmacogenomics can offer. This indicates a need for guidance on the background to this technology and how it can improve clinical trials by decreasing costs, reducing timescales, and minimising the risks in drug development. In response, we are launching a consultancy service and offering bespoke training courses to allow our customers to keep abreast of recent regulatory and scientific developments to help benefit their clinical development plans".</p>
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<p><strong>UK Biobank invests in DxS's genetic expertise<BR>
Pilot study confirms quality of collected genetic material </strong><BR>
</p>
<p><strong>Tuesday 30th August 2005, Manchester, UK</strong> - DxS, a personalised medicine company, today announced the successful completion of a molecular process pilot study for the prestigious UK Biobank. This confirmed that collection and transport of volunteer's blood from sites around the UK to the Biobank laboratories in Manchester could be undertaken without any reduction in sample quality.</p>
<p>Biobank appointed DxS to both manage the project and perform the crucial genomics element of the study. This was able to show conclusively that DNA extracted from the samples processed and stored in a variety of ways was suitable for a variety of testing. The samples were also found by other collaborating labs to be suitable for analysis using clinical chemistry, proteomic and metabolomic techniques.</p>
<p>Once fully operational, the UK Biobank will be the world's biggest resource for the study of the role of genes, environment and lifestyle in health and disease. Involving up to half a million participants over the next five years, it will build on the work of the Human Genome Project, helping to convert this information into public health benefits. A national resource of unprecedented size will be created containing biological samples and information on the participants' current health, lifestyle and medical histories.</p>
<p>Dr Stephen Little, CEO of DxS comments, "The UK Biobank is one of the most important life sciences projects in the world today. The knowledge arising from this endeavour will improve our understanding of the relationship between genes and health leading to tests for improved prediction, prevention and treatment of disease". </p>
<p>"DxS's role has to been to effectively manage the testing project and to demonstrate clearly that the genetic material collected will allow scientists to perform comprehensive testing on every sample and the company is delighted to have contributed to this flagship project". </p>
<p>Commenting on DxS's involvement, Dr Tim Peakman, Acting CEO of the UK Biobank says "DxS have made a big contribution to the success of the molecular pilot studies. They provided excellent project management support in delivering the pilot project on time and to budget with a number of leading academic collaborators across a range of disciplines. Second, they have completed a wide range of tests on the genetic material collected in the pilot producing high quality data to demonstrate that the samples will be suitable for a wide range of assays in the future".</p>
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<p><strong>Cepheid Licenses DxS Scorpions™ Technology</strong></p>
<p><strong>SUNNYVALE, Calif., July 20, 2005</strong> -- Cepheid (NASDAQ: CPHD) and DxS Ltd, today announced that DxS has agreed to license its Scorpions technology to Cepheid for use in all worldwide markets excluding clinical diagnostics, wine production and detection of chemicals used in agriculture. DxS Ltd is a private U.K. based company focused on personalized medicine.</p>
<p>"The Scorpions technology provides Cepheid with a unique combination of performance and commercial benefits, which we expect to apply to industrial markets such as Food, Agriculture and Environmental testing where we are receiving growing market demand. The first commercial products expected to use the Scorpions probes for Cepheid will be in the recreational water testing area. We expect the technology to be applicable to both our SmartCycler® and GeneXpert® Systems," stated John Bishop, Cepheid's Chief Executive Officer.</p>
<p>Scorpions™ probes are highly sensitive, sequence-specific, bi-functional molecules containing a PCR primer covalently linked to a probe. Scorpions probes provide strong fluorescent signals, excellent sequence discrimination, short reaction times, and predictable probe design. The interaction of the probe and the desired target occurs very rapidly and in advance of any competing side reactions such as the formation of internal secondary structures or re-annealing. The unique intra-molecular nature of the Scorpions reaction means that it is ideally suited for fast, quantitative, real-time PCR analysis.</p>
<p>Commenting on the agreement, Dr. Stephen Little, Chief Executive Officer for DxS, said, "We are delighted to have signed a Scorpions licensing agreement with Cepheid, one of the recognized leaders in rapid genetic testing, as it reflects growing interest and increasing industry confidence in one of our core technologies."</p>
<p>Dr. Little added, "DxS is currently in discussion with a number of companies that see an opportunity to launch products in the emerging molecular diagnostics market. Licensing Scorpions gives these companies the freedom to move into new areas and develop innovative tests."</p>
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<p><strong>Bayer HealthCare Diagnostics Division Announces Genotyping License Agreement with DxS and BTG<BR>
</strong></p>
<p><strong>Tarrytown, NY, USA and London, UK (June 28, 2005)</strong> - Bayer HealthCare, Diagnostics Division, a member of the Bayer Group (NYSE:BAY) announced today that it has entered into a license agreement with DxS and BTG. Bayer Diagnostics licensed the companies' proprietary Amplification Refractory Mutation System™ (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.</p>
<p>"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."</p>
<p><strong>Personalized Medicine and "SNPs"</strong><BR>
<BR>
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</p>
<p>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 </p>
<p>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</p>
<p>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."</p>
<p>"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.</p>
<p>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™ 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 </p>
<p>1 www.dartmouth.edu<BR>
2 HumanGenome Project Information Website, www.ornl.gov<BR>
3 CHI Reports, "Molecular Diagnostics: Technological Advances fueling market expansion. Oct 2003</p>
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<p><strong>AstraZeneca presents data on the application of DxS' ARMS™ / Scorpions™ EGFR assay for tumour mutation analysis</strong></p>
<p><strong>22nd April 2005, Manchester (UK)</strong> - DxS announce today the positive results that its genetic analysis technologies, ARMS and Scorpions, have produced for pharmaceutical leader, AstraZeneca. DxS, a personalised medicine company, provided its technology to AstraZeneca specifically for EGFR (epidermal growth factor receptor) tests in non- small cell lung cancer. </p>
<p>This week at the American Association for Cancer Research Annual Conference, (Anaheim, USA,) Alan Wookey, Global Clinical Development for AstraZeneca, (UK) delivered the following presentation "Comparison of Methods for the detection of mutations in epidermal growth factor receptor (EGFR) gene". Mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR) gene may explain some objective responses to gefitinib (Iressa) in non-small-cell lung cancer.</p>
<p>The clinical development team at AstraZeneca evaluated three different technologies to determine to optimum strategy for characterisation of novel and know mutations:</p>
<UL>
<LI>DNA sequencing<BR>
<LI>WAVE® <BR>
<LI>ARMS - Allele specific amplification / Scorpions </LI>
</UL>
<p>Dr Wookey's presentation summarised by stating that, for detection of new mutations sequencing was the preferred technology whilst the ARMS/Scorpions approach was recommended for the analysis of known mutations because of its ease of use and the increased sensitivity of the method allowed the detection of mutations which would be missed using other methods. The ARMS test was able to detect EGFR mutations when they constituted less than 1% of the total sample.</p>
<p>DxS have developed an oncology test panel that also analyses mutations in the other kinase genes including K-RAS and B-RAF. The oncology test panel uses Amplification Refractory Mutation System (ARMS™) technology, which DxS and BTG Plc have exclusive rights to licence. ARMS allows the development of very sensitive tests that can detect low level mutations in a background of normal cells. Mutations can be detected at a ratio of 1:100 mutant:normal DNA and this allows to DxS to detect genetic variation that could not be detected using DNA sequencing methods.</p>
<p>"We are very pleased with the results obtained using ARMS and Scorpions. It is becoming more and more evident that robust, highly effective DNA mutation analysis, contributes powerfully as we step towards a future of personalised medicine", concluded Dr Stephen Little, CEO, DxS.</p>
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<p><strong>DxS launches novel pharmacogenomic assay for UGT1A1*28</strong></p>
<p><strong>Manchester (UK), 20th April 2005</strong>, DxS, the genotyping services and personalised medicine company, announced today it has developed and validated a single tube assay for the drug metabolism gene UGT1A1*28. Based on the company's ScorpionsTM technology, a proprietary fluorescence-based nucleic acid detection and genotyping system developed by DxS' founders, the new test is simple to conduct, can deliver results within 30 minutes and is suitable for both real-time or end-point analysis.</p>
<p>UGT1A1*28 is a variant in the promoter region of the UGT1A1 gene. The UGT1A1 gene product is responsible for glucuronidation of various compounds, including the tumour therapy Irinotecan, along with other drugs. The FDA recently recommended that physicians prescribing Irinotecan should consider testing their patients for UGT1A1*28. </p>
<p>The promoter variant consists of an additional AT repeat in a run of 6xAT in a row; i.e. [AT]6 becomes [AT]7, and this has the effect of reducing expression of the UGT1A1 gene product. Reduced expression of the gene leads to side effects such as neutrapaenia in affected individuals. Because of the repetitive nature of the genetic variant and the high AT content (leading to low Tm and poor probe discrimination), it has proven difficult to analyse by probe-based methods. Most labs analyse this variation by size-based techniques, which are expensive and time consuming. </p>
<p>The DxS UGT1A1*28 assay is a simple PCR and read method. A typical protocol testing 5ng genomic DNA will yield a result in 30 minutes to two hours. The protocol is suitable for both real-time or end-point analysis.</p>
<p>Commenting on the launch of the new assay, Dr David Whitcombe (COO, DxS Ltd) said: "The unique properties of DxS' Scorpions technology have allowed us to produce a simple to use fluorescence-based, single tube homogeneous assay. This should prove to be a very important asset for the diagnosis of the UGT1A1*28 variation."</p>
<p>DxS has a panel of oncology tests available that also analyse mutations in the EGFR gene and kinase genes including K-RAS and B-RAF.</p>
<p> </p>
<p><strong>Expiry of PCR patents opens US market for new DNA detection systems.<BR>
DxS launches Scorpions real-time technology</strong><BR>
</p>
<p><strong>Manchester (UK) 11th April</strong>, DxS announced today that the recent expiry of the foundational PCR (polymerase chain reaction) patents in the USA has allowed it to launch its proprietary Scorpions real-time PCR technology into the world's biggest single market. Users will no longer require expensive PCR licences to access this technology.</p>
<p>Scorpions is a closed-tube PCR detection system with significant performance advantages over other methods. A DNA sample is added to a Scorpions reaction and a simple change in light output indicates the presence of a specific DNA sequence. This cutting edge technology can be used for diagnostics, environmental testing, biodefence detection, forensics and personalised medicine. </p>
<p>Commenting on the PCR patent expiry DxS CEO, Dr Stephen Little said, "until now companies have been reliant on licences from a single supplier if they wished to commercialise PCR but with the change in the IP landscape caused by the recent PCR patent expiries there a number of options available. In particular Scorpions technology offers companies a route to market for real-time PCR products, which does not rely on the 5' nuclease assay. We have already completed a number of licensing arrangements and Scorpions products and services are available in the marketplace. We expect to see a significant increase in licensing activity in the next 12 months."</p>
<p><strong>Notes to Editors:</strong><BR>
<BR>
The PCR is probably the most successful and widely used technology in molecular biology but until Monday 28th March 2005 any scientist, clinician or company performing the PCR had to be licensed under the PCR process patents, either from Hoffman-La-Roche (for diagnostic use) or ABI (research and the applied field). This situation has now changed as the patents covering the core process have expired.</p>
<p>The 8 patents which expired on Monday are only a small proportion of the total PCR intellectual property estate but they are very significant because they cover the basic concept of PCR. There are of course many other important inventions covering aspects of the PCR, for example recombinant Taq DNA polymerase which is often used in the PCR has a further year of existence.</p>
<p>One of the most valuable inventions covers methods for real-time PCR, a method for monitoring the progress of a PCR reaction so that it can be used to measure the amount of starting material. The 5' nuclease assay (often known as Taqman) is one example of a real time PCR method but the alternative Scorpions technology from DxS offers not only technical performance benefits but is also independent of other real-time PCR methods.</p>
<p>List of expired patents</p>
<UL>
<LI>4,683,195 Process for amplifying, detecting and/or cloning nucleic acid sequences
<LI>4,683,202 Process for amplifying nucleic acid sequences
<LI>4,965,188 Process for amplifying, detecting and/or cloning nucleic acid sequences using a thermostable enzyme
<LI>6,040,166 Kits for amplifying and detecting nucleic acid sequences including a probe
<LI>6,197,563 Kits for amplifying and detecting nucleic acid sequences
<LI>4,800,159 Process for amplifying detecting and/or cloning nucleic acid sequences
<LI>5,008 182 Detection of AIDS associated virus by PCR
<LI>5,176,995 Detection of viruses by amplification and hybridization </LI>
</UL>
<p> </p>
<p><strong>DxS welcomes launch of FDA Pharmacogenomic Guidelines<BR>
</strong>Guidance paper set to boost adoption of 'personalised medicine'</p>
<p>The FDA has just published its much-awaited final guidance on "Pharmacogenomics Data Submissions". <BR>
<BR>
Commenting on the announcement Dr Stephen Little, CEO of DxS, a personalised medicine company, "It is encouraging to see the FDA taking the lead in this field. It has been accepted for many years that personalised medicine is good medicine, but without the encouragement of the regulatory authorities many pharmaceutical companies have been reluctant to embrace it".<BR>
<BR>
"Clearly, the publication of this Guidance Paper will not only have a major impact on how pharmaceutical manufacturers and CROs conduct drug development programmes and clinical trials, but also the whole future of 'personalised' medicine. Personalised medicine allows the delivery of safe and effective therapies by using pharmacogenomic tests to show which patients are likely to respond well.<BR>
<BR>
The Guidance paper has been in preparation for many months and is likely to have been influenced by responses to the topics discussed at pharmacogenomic workshops held in Europe and the USA, which included: the need for guidance, types of pharmacogenomic data, and laboratory standards and diagnostics.<BR>
<BR>
A specific FDA website devoted to genome data submission has also been launched today. In addition the FDA has organised joint meeting with DIA in Bethesda, USA on 11-13 April, which Dr Little is also attending.<BR>
<BR>
If you would like an immediate post-launch discussion on the FDA guidance Pharmacogenomics Data Submissions and its implications, please feel free to call Dr Stephen Little at DXS:<BR>
Tel: +44 (0)161 606 7201 or email <A href="mailto:stephen.little@dxsgenotyping.com">stephen.little@dxsgenotyping.com</A></p>
<p> </p>
<p><strong><strong>DxS Appoints CTCLS as Japanese Agent for its Genotyping Services<br>
</strong></strong>Excellent Timing as Japan Pharma Focuses Increasingly on Pharmacogenonic Testing.</p>
<p><strong>Manchester (UK) and Tokyo (Japan), January 10th, 2005.</strong><br>
</p>
<p>DxS Ltd, the genotyping services and personalised medicine company, has appointed CTC Laboratory Systems Corporation (CTCLS) as its agent in Japan. CTCLS is a leading supplier of software, services and consultancy to the pharmaceutical industry and is well placed to help DxS build its market share for genotyping in Japan.</p>
<p>Commenting on the agreement, Andrew Webb, Sales & Marketing Director for DxS said, "The timing of this agreement with CTCLS could not be better. Not only are Japanese companies being encouraged to include pharmacogenomics in their clinical trials, the US FDA is also expected to bring out a new set of Guidance Notes early in 2005. With its established presence in the pharmaceutical industry, CTCLS is an ideal partner to grow our business in Japan."</p>
<p>In July 2003, the Japan Pharmacogenomics Consortium (JPGC) was established to promote the development of an infrastructure and national standardisation for conducting pharmacogenomics-related clinical trials in Japan. Its goal is to strengthen the international competitiveness of the pharmaceutical industry in Japan and respond to the ever-advancing need for personalised medicine. A part of this is the urgent development of a platform for conducting clinical trials involving gene analysis including post-marketing clinical trials. Through JPGC, pharmaceutical firms will be able to collaborate in solving pharmacogenomic trial issues and to synergistically develop the required know-how.</p>
<p>Mr Taizo Watanabe, President, for CTCLS added: "We are extremely pleased to be representing DxS, which is a recognised leader in pharmacogenomic testing, The Japanese pharmaceutical industry is taking a lead in promoting the incorporation of genotyping into its clinical trials, and we are now in a position to help members of JPGC in their quest for more targeted medicines."</p>
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