Preeclampsia  is a hypertensive disorder of the mother during pregnancy. It is among the leading causes of death of mother and unborn child and occurs in approximately two to five percent of all pregnancies in Germany. Early detection is critical and improves the prognosis for the further course of the pregnancy.

On the basis of next generation sequencing technologies GATC Biotech and LifeCodexx will develop a human genetic diagnostic test that will allow the detection of cell-free fetal DNA as an important early marker. The test would allow a reliable risk assessment before symptoms appear. The project is supported by grants from the KMU Innovation Program of the Federal Ministry for Research and Education with 500,000 Euros over the next two years.

"Currently there is no reliable method to predict preeclampsia. This new genetic test will therefore provide additional assurance early in pregnancy," said Dr. Wera Hofmann, Medical Director of LifeCodexx AG.

"We will immediately investigate the new PacBio RS technology for use in the test protocol. This sequencing system of the Third Generation can analyze single molecules in real-time within minutes. Costs and duration of the diagnostic test could be drastically reduced,” added Peter Pohl, CEO of GATC Biotech and chairman of the LifeCodexx.

“We are pleased to have a second diagnostic test in our development pipeline, in addition to the non-invasive prenatal diagnostic test for the determination of trisomy 21. It is another step forward towards our goal to become a leader in the field of Next Generation Molecular Diagnostics,” said Dr. Michael Lutz, CEO of LifeCodexx AG.

Contact:

LifeCodexx AG

Dr. Michael Lutz

Chief Executive Officer

m.lutz@lifecodexx.com

+49 (0) 7531 81 60 15

GATC Biotech AG

Elke Decker

Director Strategic Marketing & Corporate Communications

e.decker@gatc-biotech.com

At the moment, the only reliable way of diagnosing chromosomal irregularities during pregnancy is to use invasive prenatal methods. This causes miscarriage in about one per cent of these risky surgical procedures.
 
Scientists from the Center for Prenatal Diagnosis and Human Genetics, Kudamm-199, in Berlin have been working with scientists from GATC Biotech AG and LifeCodexx AG to develop a non-invasive diagnostic test based on Next Generation Sequencing which reliably detects a fetal trisomy 21 (Down syndrome). The test is based on the sequencing of cell free fetal DNA from the maternal blood, and in the foreseeable future it could become a no-risk alternative to the invasive prenatal examinations such as the analysis of amniotic fluid (amniocentesis) which are currently used.
 
The pilot study involved the development of an analytical method based on the publications by Chiu et al. which was verified with more than forty clinical samples. Analyses carried out with the Illumina Genome Analyzer IIx Next Generation Sequencing system unambiguously detected all eight positive samples. The test had a sensitivity and a specificity of 100%. The results were confirmed by conventional karyotyping.
 
“The results of the pilot study are very promising. From a clinical point of view, the test could be introduced relatively quickly for women with high-risk pregnancies, in particular, and used alongside the existing methods to detect genetic chromosomal abnormalities non-invasively,” says PD Dr. Markus Stumm from the Berlin Center for Prenatal Diagnosis, who presented the results of the pilot study in March during the Annual Conference of the German Society of Human Genetics in Regensburg/Germany.
 
“Prenatal diagnostics with multiplex sequencing are still very expensive. In order to drastically reduce costs in the near future, we are in the process of developing a method which allows the pooling of several samples for parallel analysis with the Illumina HiSeq2000 sequencing system,” says Peter Pohl, CEO of GATC Biotech AG and Head of the Supervisory Board of LifeCodexx AG.
 
“The method development will be concluded soon. The clinical validation study with at least 500 samples will then start immediately. We are very confident that this will also be successful. Our first prenatal diagnostic test could then be launched at the end of 2011,” said Dr. Michael Lutz, CEO of LifeCodexx AG.
 
The project was supported by BMBF funding from the ZimSolo and KMU-Innovativ programs.

Press contact:
LifeCodexx AG
Dr. Michael Lutz
Chief Executive Officer
m.lutz@lifecodexx.com
+49 (0) 7531 81 60 15

GATC Biotech AG

Elke Decker

Director Strategic Marketing & Corporate Communication

e.decker@gatc-biotech.com

The company will provide its single read sequencing services to all RCUK laboratories, including the Medical Research Council (MRC), the Institute of Animal Health (IAH), the Biotechnology and Biological Sciences Research Council (BBSRC), and the Natural Environment Research Council (NERC) to name a few.

Our unique NightXpress Service was one of the key arguments for selecting the London based GATC Biotech among a wide range of international companies.  It is a "5-to-9" overnight sequencing service which reduces the delivery time of results to just 16 hours from sample collection.

Richard Fowles for the RCUK SSC Ltd. commented: “GATC Biotech have been a preferred supplier for DNA sequencing since 2006. They have proven to be a reliable and innovative partner for many years. With NightXpress they are offering an extremely fast service which will provide our scientists with considerable time savings.”

For Mayor Horst Frank GATC Biotech is a model company for the area. He looks forward to many imitators, "Being an innovation leader, GATC Biotech helps to establish the Lake Constance region as a center for industrial innovation.”

“We are very glad to have the extra laboratory and office space,” says CEO Peter Pohl,” finally we have enough room to realize our plans and ideas in the future.”

From 2009 to 2012 GATC Biotech will have invested more than five million Euros in its Constance site. By the end of 2011 the workforce will be increased from currently 120 to 140 employees.

LifeCodexx AG announces that Dr. Martin Burow, a proven expert in the field of prenatal diagnostics, has joined its team as Head of Commercial Operations. www.lifecodexx.com/en/news.html

Within the next four years GATC Biotech plans to analyse 100,000 human genomes in particular for the pharmaceutical and diagnostic industry as well as for academic research. This will be realised by applying Illumina’s HiSeq 2000 as well as GATC Biotech’s latest acquisition, the single molecule sequencing platform PacBio RS.

To achieve this goal, GATC Biotech expands its business portfolio by opening a business unit for human genome analysis. This new strategic unit is located in the company’s German headquarters and focuses on the sequencing and bioinformatic analysis of human samples of all sizes; from small enriched regions to entire genomes.

“By the end of 2010 we will have analysed more than 100 human genomes, an even higher number as announced in 2007,” comments Dr. Kerstin Stangier, Director Business Development and head of the new business unit. “Based on this experience and know-how, we can offer highest flexibility and quality as well as short delivery times. The new business unit includes a LIMS controlled production workflow with automated library preparation and an extensive bioinformatics pipeline which can be adapted to any project goal. Current collaborations, for example with the International Cancer Genome Consortium, have been very helpful for the development of this pipeline.”

GATC Biotech is Europe’s leading sequencing service provider. The company more than doubled its staff within the past three years and has currently close to 120 employees.

GATC Biotech announced today that it has agreed to purchase the PacBio RS platform, a single molecule, real-time (SMRT™) sequencing technology. The new PacBio RS will be the fifth sequencing technology for GATC Biotech. The system is planned for installation in early 2011.

GATC Biotech plans to use the new platform for resolving structural variations, for example in human cancer genomes, and for the detection and confirmation of rare SNPs. In addition, the future application to enable direct sequencing of methylated bases will make the system attractive for regulatory studies, for example for the pharmaceutical or diagnostics industry.

“Pacific Biosciences has chosen GATC Biotech to be our first European service provider because the company is well experienced in applying major sequencing technologies in a broad spectrum of projects and in gearing up new sequencing technologies quickly for lab routines,” comments Terry Pizzie, Vice President, Europe for Pacific Biosciences.

“We are looking forward to offering our customers PacBio’s third-generation sequencing platform and are confident that we will be able to offer the SMRT technology to our customers within a short period of time after successful installation,” adds Thomas Pohl, Chief Technology Officer of GATC Biotech.

GATC Biotech is Europe’s leading sequencing service provider. The company more than doubled its staff within the past three years and has currently close to 120 employees.

GATC Biotech to sequence samples from brain tumors in children for the world’s largest cancer research project. The aim of the German PedBrainTumor Consortium within the ICGC is to develop innovative diagnostic methods and treatments in order to be able to provide children with therapies which have fewer side effects in future.

GATC Biotech sequences genomes from tumor tissues and the corresponding controls from healthy samples of the same patients. It uses sequencing technologies from Illumina Inc., including the new Illumina HiSeq 2000. This instrument is currently the most efficient sequencing system with up to 200 gigabases per run. The complete genomes are sequenced with a 30-fold coverage to ensure reliable data assessment. The data will be supplied to the DKFZ in fall 2010. The order value is Euro 750,000.

“Brain tumors are the main cause of cancer deaths in childhood. Therapies with few side effects are urgently required to make it easier for the children to bear the taxing treatment. The PedBrainTumor Project will bring us a great deal further forward in the development of such therapies. GATC Biotech proved itself to be a reliable sequencing partner in the pilot phase of the project and so we are now continuing that successful collaboration,” comments Professor Peter Lichter, project leader and spokesman of the German ICGC group.

“We are fully aware of the importance of this project and our responsibility. We are very proud to be allowed to support the DKFZ within the framework of the PedBrainTumor project,” says Peter Pohl, CEO of GATC Biotech.

The PedBrainTumor Consortium, a German contribution to the International Cancer Genome Consortium (ICGC), will receive Euro 15 million from the German Federal Ministry for Education and Research (BMBF) and German Cancer Aid (Deutsche Krebshilfe e.V.) over five years. The project is managed by the German Cancer Research Center (DKFZ) and will investigate the molecular genetic causes of pediatric brain tumors. The scientists expect the results to provide starting points for new innovative therapies.

The German Cancer Research Center in brief
The German Cancer Research Center (DKFZ) is the largest biomedical research facility in Germany and a member of the Helmholtz Association of German Research Centers. More than 2,000 members of staff, including 850 scientists, study the mechanisms of carcinogenesis and work on the compilation of cancer risk factors. They provide the bases for the development of new approaches to the prevention, diagnosis and treatment of cancers. Furthermore, the staff of the Cancer Information Service (KID) inform cancer sufferers, relatives and anyone who is interested about this endemic disease. The Center receives 90 percent of its funding from the German Federal Ministry for Education and Research and 10 percent from the Federal State of Baden-Württemberg.

LifeCodexx AG aims to successfully establish “Next Generation Molecular Diagnostics” in Europe. This will provide improved diagnostics for targeted, cost-efficient treatments. LifeCodexx AG is owned by GATC Biotech AG, which has a majority holding in the company, and other private investors. The test development currently being undertaken also receives public funding, including up to EUR 300,000 from the ZIMSolo and KMU Innovativ funding programs.

LifeCodexx AG has been able to convince a CEO with know-how in this field to join the company - Dr Michael Lutz, former Global General Manager of Cogenics and CEO of Epidauros AG. Dr Lutz has many years of experience in developing and managing innovative biotech companies.

“LifeCodexx AG has a revolutionary concept - to carry out human genetic diagnostic tests based on state of the art sequencing technologies. This will drastically improve cost efficiency in diagnostics. LifeCodexx AG will be a trailblazer here," enthuses Peter Pohl, CEO of GATC Biotech and Chairman of the Board of LifeCodexx AG.

“Our test pipeline in prenatal diagnostics shows encouraging results which we will present in the coming months. I am delighted to be able to apply my experience to these innovative projects,” emphasizes Dr. Michael Lutz, new CEO of LifeCodexx AG.

Presscontact:

LifeCodexx AG

Dr. Michael Lutz

Chief Executive Officer

m.lutz@lifecodexx.com

+49 (0) 7531 81 60 15

Over the past few years, the range of treatment options for breast cancer has improved significantly. A number of therapies using new drugs will become available in the foreseeable future. Not every patient, however, responds well to these therapies. The course of disease can therefore vary considerably from one person to another, causing severe side effects in some patients. One reason for these individual differences lies in the variability of our genetic material, the DNA.

In cooperation with the Feldkirch District Hospital (Landeskrankenhaus Feldkirch) and the Lake Constance Breast Centre (Brustzentrum Bodensee) represented by the Gynaecological Hospital at the Constance Hospital (Klinikum Konstanz) as well as GATC Biotech AG, Constance, genetic alterations which influence, for example, the effect of drugs are analysed on the basis of comprehensive and well characterised patient groups, using state-of-the-art laboratory techniques. “By means of tissue and blood samples, we will carefully examine certain patient DNA regions which may influence the mechanism of action or the metabolism of drugs,” explains Axel Mündlein, Head of Laboratory at VIVIT in Dornbirn.

Fewer side effects due to optimal forms of therapy

Information gained from the genetic analysis of a breast cancer sufferer should help to derive a therapeutic approach which is best suited to the individual patient. Likewise, treatments to which patients do not respond should be excluded early on and avoidable side effects and unnecessary cost to the health care system should be reduced significantly. First results should become available by 2011, and the project is due to be completed by mid-2013. The project is co-financed with funds from the EU and the Interreg IV-Programme "Alpenrhein-Bodensee-Hochrhein".

BioLAGO Association got the ball rolling

“Without the BioLAGO-platform this project wouldn´t exist “, states Axel Mündlein. The idea for the project was borne when Mündlein and Peter Pohl, CEO of GATC, a biotechnology company in Constance, met and exchanged views at an event organised by the BioLAGO-network. About a year ago the two members first came into contact within the network for modern life sciences. According to the geneticist Mündlein the advantages of the cooperation are obvious: “GATC has the latest technologies to decode the human genome at its disposal, and, in addition, the geographical proximity facilitates effective cooperation “, explains Mündlein.

The cooperation is dominated by the concept of BioLAGO, an association founded in 2007. Since mid-2008, the international network has a central office at the Technology Centre Constance and is working intensively on bringing together researchers, entrepreneurs and medical practitioners to develop new projects and products as well as to strengthen the economic position of the region. “This project proves that the integration of research and business sector within the frame of an industry –specific platform is bearing fruit “, observes Andreas Baur, CEO of BioLAGO.

VIVIT (Vorarlberg Institute for Vascular Investigation and Treatment)

VIVIT ist ein privater gemeinnütziger Trägerverein zur Forcierung der angewandten medizinischen Forschung in der Region Vorarlberg. Schwerpunkte der Forschung des VIVIT sind Diabetes mellitus, Herzerkrankungen,  Beingefäßerkrankungen und Schlaganfall sowie Themen aus der Onkologie und Nephrologie. Hierbei können alle Fachrichtungen auf Analysedienstleistungen eines eigens dafür eingerichteten molekularbiologischen Labors zurückgreifen, um u.a. erbliche bedingte Prädispositionen für Erkrankungen in den genannten Bereichen zu untersuchen. Neben seinen Forschungstätigkeiten führt das VIVIT klinische Studien im Auftrag überregionaler Unternehmen am akademischen Lehrkrankenhaus Feldkirch durch. Das VIVIT gehört im Bereich der vaskulären Forschung österreichweit zu den aktivsten Instituten und liegt europaweit derzeit im Spitzenfeld. (Kontakt: Dr. Axel Mündlein, Tel.: +43 5572 372 65 81, Fax +43 5572 372 65 84, labor@vivit.at)

GATC Biotech today announced the purchase of Illumina’s new HiSeq 2000 sequencing platform, which has officially been launched last week. This latest acquisition will further strengthen GATC Biotech’s current fleet of three GA IIx.

Initially, the company will employ the HiSeq 2000 to human genome sequencing projects from its customers in the pharmaceutical and medical research field. It will also make the system’s high data output available to the industrial and academic research community interested in the high throughput sequencing of larger eukaryotic genomes.

“Illumina’s HiSeq 2000 with the estimated output of 200 GB per run allows us to virtually sequence 60 human genomes at 1x coverage in a week. Being an Illumina CSPro certified service provider we are confident to have the system quickly installed and geared up for production,” says Peter Pohl, CEO of GATC Biotech.

The HiSeq 2000 sequencing system had just been launched by llumina Inc. on the occasion of the J.P. Morgan Healthcare Conference last week in San Diego.

“GATC aims to continually offer our customers the most innovative, efficient and integrated sequencing technologies and applications for their research projects. To achieve our 100-Human-Genome-Project goal, evaluating Complete Genomics’ human genome sequencing technology is a logical step,” explains Peter Pohl, CEO of GATC Biotech.

“We are pleased to be working with GATC Biotech on this project which will further demonstrate the value of our large-scale, high-quality, low-cost human genome sequencing service,” said Dr. Clifford Reid, chairman, president, and CEO of Complete Genomics.

About Complete Genomics
Founded in 2006, Complete Genomics is a California company that has developed a
novel approach to sequencing human DNA that is revolutionizing the human genome
sequencing industry. Complete Genomics combines its proprietary third-generation
DNA sequencing technology with its high-performance computing capabilities to deliver
low-cost, high-quality genomic data on an unprecedented scale. The company is
currently building the world’s largest human genome sequencing center. This
development will allow academic and biopharmaceutical researchers, for the first time,
to conduct large-scale complete human genome studies that will help identify the
genetic underpinnings of complex diseases and drug responses. For additional
information about the company, please visit www.completegenomics.com.

Complete Genomics, Inc. | Jennifer Turcotte, Vice President of Marketing, Tel. (650) 943-2846, jturcotte@completegenomics.com

Through the GATC London Laboratory, customers benefit from a free courier delivery service of less than 24 hours. In addition, in many cities throughout the UK and Ireland GATC offers a free sample collection service in the evening with overnight shipment directly to the GATC London Laboratory.

NightXpress - Overnight sequencing service

GATC Biotech plans to install a unique "5-to-9" overnight sequencing service, called NightXpress, which will reduce delivery times to just 16 hours from sample collection. From Monday to Friday, DNA samples will be collected for free from 5 pm at defined GATC Sample Collection Points and by 9 am the next morning, including Saturdays, DNA sequencing results will be ready for download. With GATC’s overnight service scientists will gain a head start for follow-up experiments of almost two days. NightXpress will start operations on February 15, 2010, initially with customers in London and surrounding areas.

Peter Pohl, CEO at GATC Biotech comments: "With NightXpress we offer the world’s fastest sequencing service. Being already the first company in Europe to offer commercial sequencing services, GATC Biotech once again sets new standards by delivering mass customized sequencing services with fastest delivery times and at competitive rates."

The GATC NightXpress service was first launched in Germany in 2007 and GATC now plans to adopt the successful concept for the UK, where the company maintains a subsidiary since 2004. In the past years GATC has built a network of GATC Sample Collection Points that are located in Cambridge, Oxford, Newcastle-upon-Tyne, Harwell, London, Liverpool, Leeds, Leicester, Manchester, Aberdeen, Glasgow, Edinburgh, and Dublin, and the company plans to extend this network further.

GATC Biotech applies a highly automated sequencing platform for mass customization using technologies such as Applied Biosystems ABI 3730xl, Roche Diagnostics GS FLX and Illumina Genome Analyzer IIx. The GATC London Laboratory, located nearby the Imperial College and UCL is subject to the same stringent quality standards and automation as the laboratories in GATC’s headquarters in Constance, Germany.

About LBIC - www.lbic.com

The London BioScience Innovation Centre (LBIC) provides a focus for life sciences activity in the UK capital, offering laboratory and office facilities of an exceptionally high standard and a professional front door that cannot fail to impress. Owned by the prestigious Royal Veterinary College, LBIC is the first and only incubator for biotechnology companies in central London and is home to biotechnology and diagnostic companies, life science product and service providers, venture investors and small pharmaceutical companies. The centre benefits from shared networking space and meeting rooms and is in close proximity to the various financial services available throughout the Capital. LBIC is centrally located, just a ten minute walk from both Kings Cross and Euston mainline stations, next to the Royal Veterinary College.

The mayor Claus Boldt, together with architect Hans-Peter Engelmann and Director Peter Pohl, officially turned the first sod, thus marking the beginning of the expansion the Constance site of GATC Biotech, Europe's leading sequencing service provider.

The company will invest more than 5 million Euros in its Constance headquarters until 2012 to create offices, laboratories and up to additional 100 jobs.
 

An extra 960 square meters will more than double the existing laboratory and office space. The three-storey annex will be directly attached to the original building. A completely glazed foyer will connect the old and the new building. The architect's office Giel & Engelmann in Constance is responsible for planning and construction supervision.

An extra 960 square meters will more than double the existing laboratory and office space. The three-storey annex will be directly attached to the original building. A glass atrium will connect the old and the new buildings. The architect's office Giel & Engelmann in Constance is responsible for planning and construction supervision.

"Because of our company's strong growth over the last few years, we are in dire need of a new building. We are literally bursting at the seams as we have more than doubled the number of our employees since 2006. Furthermore, we urgently need further laboratory space in order to expand our sequencing capacity to 30 terabases until 2013. This increase in capacity is required to enable us to advance our international expansion plans. We are very proud that we are able to create and secure jobs even in economically difficult times and to strengthen and further expand the dynamic life science cluster at Lake Constance," says Peter Pohl.

The inauguration of the annex in spring 2010 will coincide with GATC’s 20th anniversary.

You can follow the construction works live at www.gatc-biotech.com.

As part of a two-stage certification process for Next Generation sequencing with the Genome Analyzer IIx, the laboratories in Constance and the sequencing data generated were subjected to extensive tests. In the future, this quality certificate will be confirmed by annual audits and supplemented with additional training measures.

As a CSPro certified service provider, the European market leader GATC Biotech can immediately have access to the latest technical developments, platforms and upgrades from Illumina Inc. This allows extremely rapid advancement of applications and extended solutions for individual sequencing projects which directly profit the customers.

The announcement, made at a press conference at BIO-Europe 2007, the world’s largest biotechnology industry networking event, comes at a time when the US FDA has just recommended that clinicians obtain patients’ genetic profiles before prescribing warfarin. The FDA is promoting personalised medicine as part of its ‘Critical Path Initiative’ to encourage innovation in drug development.

Improved access to genomic data could transform the diagnosis and treatment of cancer, Professor Dr. Christof von Kalle from the German National Center for Tumor Diseases, told the press conference. “By sequencing and comparing genomes obtained before and after the diagnosis of cancer, researchers can gain a better understanding of the genetic basis of cancer, particularly the role of the previously understudied non-coding regions. There is growing evidence implicating these areas, which comprise 98.5% of the human genome, in the onset and control of cancer.”

Peter Pohl, the CEO of GATC, who also spoke at the event, explained that his company will build the capacity and expertise to initiate and deliver this visionary, but tough, project. GATC has nearly two decades of DNA sequencing expertise, having sequenced close to 100 microbial genomes since 1990, and, uniquely in Europe, uses all four leading high throughput sequencing technologies.

The first human genome sequenced cost $3 billion; this cost has now fallen to about $5 million. GATC plans to bring down the cost of human genome sequencing further and to provide a clearer picture of the human genome by using next-generation sequencing and high-end bioinformatic technologies. Their visionary aim is to deliver, in ten years, a quality dataset for 500 Euros, making it a realistic option for pharmaceutical research. GATC is the first sequencing company worldwide to offer whole human genome sequencing to industry and academia.

Infectious diseases, after cardiovascular diseases, are the most frequent cause of deaths in the world (WHO, 1999). Approximately 18 million cases of sepsis occur world-wide per year. The mortality rate for sepsis is 28-50%, and the associated costs are estimated at €7.6 billion. Quick and precise diagnosis of sepsis is crucial to the success of a course of a therapy. Current diagnostic processes rely on time-consuming cultivation of pathogenic microbes. The DNA microarray-based diagnostic under development will enable the immediate detection of organism-specific nucleic acid sequences, offering the advantage of reducing the time between sample collection and diagnosis, leading to a reduction in mortality rates.

The project is one of several that connect GATC Biotech’s DNA analysis expertise with demanding medical conditions. Additional projects that GATC Biotech is contributing to include CONSERT (Concerted Safety and Efficiency Evaluation of Retroviral Transgenesis for Gene Therapy of Inherited Diseases), XENOME (detection of retroviral elements in the porcine genome), and EURESFUN (integrated post-genomic approaches for the understanding, detection and prevention of antifungal drug resistance in fungal pathogens). The Company collaborates with the Fraunhofer Institute on EURESFUN, and also partnered with the Institute on the successfully completed project IDENTIGENE (development and validation of new suitable technologies for gene expression studies to identify functional candidate genes without the use of specific DNA probes).

Peter Pohl, CEO of GATC Biotech, commented: “We are delighted to be taking part in this collaboration. With nearly two decades of experience in genetic analysis, GATC Biotech is ideally positioned to contribute to research projects relating to human health. The clinical diagnostics field is still dominated by classic microbial procedures, involving the time-consuming cultivation of pathogenic germs. The successful development of a DNA-based diagnostic will reduce the time between sample collection and diagnosis, and will represent a huge step towards increasing survival rates for patients.”