6 min readCurrent Trends in Genomic Applications within Europe
Currently, genomic applications have become more feasible with the integration of computer-aided software that serves pharmaceutical and biotech companies by speeding up drug development processes. Pharmacogenomic testing has allowed researchers to predict the propensity and the etiology of a number of diseases, aiding researchers to formulate preventative measures. Owing to this, pharmaceutical companies, amidst stiff competition, are always in the process of developing customized drugs for targeted therapy.
PCR has been a revolutionizing tool for researchers in the life science sector. Even though conventional PCR techniques are well established within Europe, advances in PCR technology including real-time and quantitative PCR (qPCR) that permit the amplification of genetic material within a very short period, have heightened expectations of greater uses for the technology.
Pharmacogemics’ mission is to transform medicine from prescribing treatment based on patients’ symptoms to therapies based on the patients’ genetics. The use of pharmacogenomic diagnostics will complement the development of a drug’s performance in clinical trials, reduce product failures and encourage more immediate application. The availability and use of a gene-based diagnostics would enhance a product’s market share by demonstrating unmatched clinical efficacy. The drug’s lifetime will be extended and the drug’s manufacturers are likely to increase their market share.
The improving clinical benefits would justify premium pricing strategies that will cover diagnostic and product development costs. Based on market requirements stipulated by organisations, on an average the number of new molecular entities (NME) entering the market should increase by at least 50% to meet required objectives. This has led to a number of industrial consolidations among market participants.
Current European Scenario
Europe has witnessed a steady growth in the field of genomics since the turn of the century. Major factors influencing the market within this region include research and development (R&D) expenditure, product development and supply chain management costs. Genomics has allowed pharmaceutical companies to concentrate in areas such as genetic diagnostics and improved information technologies that allow biological information to be managed and analysed. Current research prospects involve crossing the barrier of sequencing the human genome for identifying novel genes and therapeutic targets. Combining automated technologies such as robotics and micro-arrays have further broadened the scope for genomics. Single nucleotide polymorphism (SNP) based DNA fingerprinting is one such example that is now widely used not only in clinical diagnostics but also in areas such as forensic and environmental sciences.
Universities and Funding bodies across Europe have initiated several projects employing genomic approaches for disease diagnosis and cure. The Welcome Trust is supposedly UK’s largest charity organization, and in September 2007 it announced a $2.4 million award to fund a genome-wide association study to identify the genetic origins of Alzheimer’s disease. The study would primarily compose of collecting and scanning DNA samples from about 6000 patients suffering from late-onset Alzheimer’s from the both the UK and USA for identifying common genetic variations.
Another area of focus is viral outbreaks, where devising effective counter measures are of prime importance. There have been an increasing number of establishments across Europe that are in the process of developing anti-viral vaccines to target complications such as SARS and avian flu. Vizier, a wide-ranging consortium of 23 European laboratories has been in process of gathering and collating genomic data to tackle infectious outbreaks. Their primary task would be to sequence the genetic map of various viruses, define their proteins and search for crucial sites on them that could be blocked by drug action.
Advances in Software integration
A major milestone in genomic research was the integration of powerful software for data interpretation and management. Computer modelling approaches such as enzyme-substrate modelling (ESM), homology modelling (HM) and molecular dynamics (MD) are gaining high acceptance due to advantages over conventional time-consuming assays. Major market players in this industry include, Accelrys DNAStar, Gene Codes and Spotfire. There is increasing interest from the Information and Technology (IT) giants like Apple, Cisco Systems and IBM to invest in genomic research. This in turn has led analytical instrumentation manufacturers such as Affymetrix, Bio-Rad and Beckman Coulter to concentrate more on software development for both instrument operation and data analysis.
The acceptance level of gene-based screening for diseases has been relatively low within Europe when compared to the USA. This is primarily because; throughout Europe the protection of genetic data is considered as a requirement in order to guarantee respect for the equality principle, and to make the right to health a reality. The processing of genetic data in Europe has been subjected to stronger protection as provided in the in the Directive 95/46/EC and the national laws of the EU member states implementing it. In order to overcome these problems, the European Commission has called for a networking exercise primarily aimed at generating an inventory report on genetic determinants relevant to public health. Primary objectives of this network would be to identify health issues that could be linked to current national practices in applying genetic testing. The Public health genetic/genomics European network (PHGEN) is one such organisation. They conduct regular networking exercises on public health genomics (PHG) for all the EU member states. The Biocrystallography (X) on a highly integrated technology (BIOXHIT) platform for European structural genomics was a project started under the sixth framework (FP6) program of the European commission. Applying genome-sequencing technology, the project aims to employ X-ray crystallography to determine the 3-Dimensional structure of macromolecules.
High content screening platforms developed by companies such as Applied Biosystems aid researchers in identifying multiple compounds and their potential toxic effects on genetic material. The company’s Cellomics ArrayScan VTI system works by analysing the micronuclei formation that are a strong indicator of genetic toxicity caused by environmental or drug-candidate toxins. Other upcoming techniques include the use of RNA editing for high-throughput screening. RNA editing is essential for accurate production of coded proteins. The lightCycler 480 platform developed by Roche Applied Science allows researchers to scan RNA transcripts for both new editing sites and the quantification of their editing. The company has further formulated an agreement with Nungen technologies in developing a RNA amplification kit employing Nungen Technologies’ proprietary WT-Ovation technology.
Advances in micro-array technology
An important technology based sector that is showing widespread acceptance among the European public is the micro-arrays sector. Increasing interest among the public to gain access to personal genomic data has led to the establishment of many firms within the EU. For example, the German based GATC–Biotech is launching a subsidiary called LifeCode that primarily provides genomic profiling services employing micro-arrays to the EU members. The services will be available in German, English and French. The company is still in the process of evaluating two available platforms, Affy (Affymetrix micro-array) and Illumina. GATC-Biotech is the leading provider of genome sequencing, employing Solid, GS FLX and Genome analyzing technology. The incorporation of new biomedical technologies in the diagnosis and prognosis of cancer is changing medicine to an evidence-based diagnosis.
Transcriptomic profiling observed using DNA micro-arrays and the integration of heterogeneous sources of data obtained via micro-arrays could also aid in deducing the behaviour, the origin, and the discrimination of tumour types. The major advantage of this technology is its flexibility in manufacturing as a commercial product. deCODE Genetics is a biopharmaceutical company based in Reykjavik, Iceland. The company specialises in genetic profiling and applying it in the analysis of genetic abnormalities for disease diagnostics and drug delivery. Recently the company introduced their PrCa prostate DNA test. This test is available to physicians and medical practitioners and it involves the analysis of eight SNP’s related to prostate cancer. In January 2008, Proactive Genomics introduced their Focus5 Prostate Cancer Risk Test that examines five SNP’s.
Agilent Technologies recently granted Oxford Gene Technology (OGT) the status of their micro-array certified service provider (CSP) for Europe. OGT have been involved in a number of projects including transcription profiling of pathogenic microorganisms and array based comparative genomic hybridization (aCGH). The expertise in micro-array services provided by Agilent Technologies would help OGT in further revamping their application specific approaches using high density and high sensitive micro-arrays. Both companies have earlier pioneered this sector with the development of their inkjet in-situ synthesis (Ijiss) technique. LGC recently announced the development of a prototype micro-array quality control material that could be used as a generic reference standard across multiple platforms and applications. The material was initially developed for the evaluation of gene expression and genotyping model array systems.
Like any other technology, the impact of genomics on health services will be influenced by the rate at which tests and therapies emerge along with their acceptance by the public. Sensing a complication would no longer be necessary with the help of genetic screening. Targeted therapies would prove to be a lifeline for patients with complications such as cancer. Health insurance models could also change and would be devised in ways to predict an individual’s lifetime health expenditure. Pharmaceutical companies are aware of the ongoing consolidations among the industry participants, primarily to acquire and implement new technology in the field of genomics. The combination of advanced software platforms along with high throughput instrumentation employing genomic approaches will dominate the European life sciences market in years to come.