- Epigenomics AG
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Epigenomics AG Launches Diagnostic Lung Cancer Test in Europe
- The Epi proLung BL Reflex Assay complements conventional diagnostic methods
- Test may identify cancers otherwise missed
- Epigenomics' second molecular diagnostic product launched in Europe
- Commercial potential from direct sales as well as licensing and partnering going forward
Epigenomics AG (Frankfurt Prime Standard: ECX), a cancer molecular diagnostics company, has launched the Epi proLung BL Reflex Assay, its second CEmarked in vitro diagnostic (IVD) product, in Europe today. The novel molecular diagnostic test can help pathologists and clinicians to establish the presence of malignancy with more certainty in patients with suspected lung cancer when conventional diagnostic procedures fail or deliver inconclusive results.
"Epi proLung is the second IVD product we have introduced into the European market, only nine months after we began offering Epi proColon, the blood test for colorectal cancer early detection, in October 2009," commented Geert Nygaard, Chief Executive Officer of Epigenomics AG.
"Over the last two years we have established an efficient product development organization fully compliant with all applicable laws and regulations. This organization now has shown once more that starting with a clinical question it can systematically develop and launch innovative molecular diagnostic tests that address important challenges in the early detection and diagnosis of cancer."
The Epi proLung BL Reflex Assay detects methylated DNA of the SHOX2 gene in bronchial lavage. This sample material is routinely obtained during the clinical workup of patients with suspected lung cancer. Increased DNA methylation of the SHOX2 gene indicates the presence of malignant lung disease.
The clinical utility of the novel test has recently been demonstrated in a performance evaluation study, the final step of Epigenomics' IVD product development, with individuals that have undergone diagnostic workup for suspected lung cancer within the Roy Castle Lung Cancer Foundation's Research Program at The University of Liverpool Cancer Research Centre directed by Professor John K Field. The study confirmed previous research studies showing that methylated SHOX2 DNA is a sensitive and highly specific biomarker for the detection of lung cancer in bronchial lavage specimen.
"In the recent performance evaluation study, it was particularly interesting to see that the test identified a large proportion of cancers that were originally missed at the time of the first bronchoscopy," stated Prof. John K Field, who closely worked with Epigenomics in the clinical evaluation of the SHOX2 biomarker. "This shows that the test has the potential to complement conventional approaches used to establish the presence of malignant lung disease," he continued.
Dr. Bernd Schmidt, Head of the Department of Pneumology at the University Hospital Halle, Germany, who advised Epigenomics on the medical need and clinical use of the test in Germany throughout the research and development phases remarked: "The test will help pathologists and clinicians to extract more relevant information from bronchial aspirates, samples we obtain anyway in those cases where we cannot reach the suspicious area of the lung with the endoscope. This may allow physicians to establish a diagnosis with more certainty in the many inconclusive cases -- at no additional risk or discomfort for the patient."
With about 386,300 new cases in Europe in 2006 and about 219,000 new cases in the U.S. in 2009, lung cancer is one of the most common cancers in men and women and is the cancer with the highest mortality rate worldwide.
The overall objective of a diagnostic workup, when cancer is suspected, is to establish the definitive diagnosis with the least invasive methods and thereby minimize the patient's risk. Individuals suspected of having lung cancer typically undergo chest Xray or CT scanning followed by more invasive procedures like bronchoscopy, i.e. the visual inspection of the bronchial airways with an endoscope. The diagnosis is typically confirmed by an analysis of tissue directly obtained from the tumor by a biopsy obtained during bronchoscopy or by analyzing cellular material e.g. from rinsing the airways with saline solution during what is called a bronchial lavage. However, in routine care for approximately half of the suspected cancer cases, cytology and histology do not provide conclusive results at the time of first bronchoscopy. The need to confirm the diagnosis often leads to further time consuming and costly procedures bearing additional risks for the patient.
The Epi proLung BL Reflex Assay has been developed as an aid in the diagnosis of lung cancer providing additional information to confirm the presence of malignant lung disease using routinely obtained bronchial lavage fluid. The test provides the opportunity to diagnose more patients with a much higher degree of certainty at the time of first bronchoscopy. Patients with positive test results may then be funneled into accelerated clinical staging and therapy, avoiding delays and potentially reducing costs.
In Germany, about 172,000 bronchoscopies are performed for suspected lung cancer every year. For the introduction of the novel test, Epigenomics will work with a selected number of pathology institutes at university hospitals with a focus on lung cancer in Germany and Switzerland. These reference centers will include Charité -- University Medicine Berlin and University Hospital Zurich. Leading pathologists and clinicians at these reference centers will provide scientific and medical oversight in the launch phase. Following the successful introduction into these home markets, Epigenomics intends to address further European markets through direct marketing and sales as well as distributors. In line with its dual commercialization strategy, the company is also looking at licensing the biomarker to other in vitro diagnostic industry players.
"At a stage where the assay is fully validated and mature, we have maintained full commercial control over this product and the biomarker which allows us to leverage its commercial potential in the best possible way by direct product sales as well as distribution and licensing partnerships at the optimal time in the product life cycle", Geert Nygaard explained.
About Epi proLung
Epi proLung BL Reflex Assay has been developed as an in vitro diagnostic realtime PCR test kit for the analysis of SHOX2 gene methylation in bisulfite converted DNA isolated from human bronchial lavage fluid.Based on clinical research, it is believed that the presence of methylated SHOX2 DNA is associated with, and may aid in, the diagnosis of invasive carcinomas of the lung.
For more information on the Epi proLung BL Reflex Assay and its availability in Europe please visit www.epiprolung.com or contact Epigenomics directly by Email firstname.lastname@example.org or phone +49 30 24345 111.
About the University of Liverpool
The University of Liverpool is a member of the Russell Group of leading researchintensive institutions in the UK. It attracts collaborative and contract research commissions from a wide range of national and international organisations valued at more than £98 million annually.Visit www.liv.ac.uk
About The Roy Castle Lung Cancer Foundation
The Roy Castle Lung Cancer Foundation (Registered Charity England & Wales 1046854 - Scotland SC037596) is the only charity in the UK wholly dedicated to defeating lung cancer -- the biggest cancer killer in the world. Its approach benefits current and future lung cancer sufferers alike:
- The foundation funds research programs to detect lung cancer at a very early stage, which will save lives and is vital to the development of a future therapy.
- The foundation offers patient support, advocacy and an information network providing information, guidance and support relevant to the needs of lung cancer patients and their families.
- The foundation facilitates support groups across the UK that help sufferers to come to terms with the disease and provide patient advocacy services.
- The foundation operates 'Quit Smoking' services for adults (Fag Ends).
- KATS (Kids Against Tobacco Smoke) educational program for children which encourages young people never to start smoking.
- ATYC (Anti Tobacco Youth Campaign) which gives young people a voice, knowledge and skills to campaign about smoking and other tobacco issues.
- The Roy Castle Lung Cancer Foundation runs fundraising events and charity shops, both of which help to generate much needed voluntary donations (public and corporate), on which it relies to continue its fight to defeat lung cancer.
If you would like to know more about how you can support the Roy Castle Lung Cancer Foundation, please contact +44 (0)151 254 7200 or visit www.roycastle.org for further information.
Epigenomics' product portfolio contains the CEmarked IVD test Epi proColon, the world's first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, Epi proLung, a CEmarked test kit to aid in the diagnosis of lung cancer, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with nonexclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, ARUP Laboratories, Inc., and Warnex Inc. for diagnostic test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, U.S.A. For more information, please visit Epigenomics' website at www.epigenomics.com.
Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forwardlooking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forwardlooking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forwardlooking statements contained herein as a result of new information, future events or otherwise.
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