Opaldia - Press Releases

OPALDIA TO LAUNCH BREAST CANCER BLOOD TEST IN 2008	Dec 14, 2007

The leading private breast cancer care provider, Opaldia (1), is to launch a diagnostic blood test for early stage breast cancer. The test has been developed by Norwegian life sciences company DiaGenic ASA. Opaldia will market the test in the UK once it gains CE-marked status, expected towards the end of next year. The test works by detecting gene expression patterns (2) in peripheral blood – ie: a normal venous sample - not taken from the breast. A blood test will give women the opportunity to detect breast cancer in its earliest stages – when usually undetectable by touch or mammograms - and when they have no symptoms. The blood test has been validated in international trials, most recently in India, suggesting there is no ethnic variability in the gene expression signature. “I think it is really important to investigate better ways of detecting early breast cancer in young women. “All health professionals who work with breast cancer are concerned that mammograms may be sub optimal in young women under 47. Therefore a new test used alongside mammography would provide the optimal chance of detecting the cancer as early as possible. Dr Mackay, who is the UK’s only Consultant Clinical Genetic Oncologist, adds: “The DiaGenic breast cancer blood test is an exciting new weapon in the fight against breast cancer. By using the test and mammography together we may be able to detect tumours at an early stage. “The test analyses the expression of genes which are not specifically cancer genes. “By studying these non-cancer genes, experts can detect a specific, distinctive gene expression pattern. “This is breast cancer's unique fingerprint, in blood.” Dr Erik Christensen, managing director of DiaGenic, says: “We are excited to be collaborating with such a leading company in the breast cancer field as Opaldia.” Professor Anne-Lise Børresen-Dale, of the Institute of Cancer Research in Oslo, Norway, and who sits on DiaGenic’s Scientific Advisory Board, is to give a speech on reducing breast cancer mortality at the Genesis conference in London on December 11. She will describe the DiaGenic blood test as an exciting new development in the field of breast cancer diagnostics. Prof. Børresen-Dale is president elect in European Association for Cancer Research (EACR) and former Member of The Board of Directors, American Association for Cancer Research (AACR). Editor’s Notes: Opaldia is a private healthcare provider which aims to provide a lifelong breast cancer screening service to its members. All its services are offered in independent hospitals by consultants. Other gene expression tests offered by the company in the breast cancer field are: MammaPrint – for disease prognosis; and CupPrint, which identifies the unknown origin of some tumours that have metastasised. Gene expression tests analyse the presence and abundance of mRNA molecules – the copy of DNA that is made before it is itself decoded and ‘read’, or transcribed, into a protein. By looking at patterns of lots of genes switching on (high mRNA abundance) scientists can analyse a ‘gene expression signature’. By comparing the pattern of healthy tissue or blood to diseased tissue or blood, they can observe the changes in gene expression that occur when disease develops. This can then be used as a test to diagnose disease. DiaGenic is an innovative Norwegian biotechnology company that seeks to create value for patients, partners, and investors by developing new and more patient friendly methods for early detection of diseases. DiaGenic is currently a world leader in analyzing gene expression signatures related to disease in easily available clinical samples such as peripheral blood. This unique method is based on the principle that even when a disease is localized at a specific part of the body, secondary responses, which are also characteristic of the disease, can be measured in other parts. Significant potential in numerous diseases such as breast cancer and Alzheimer's disease has been identified. The company has been granted patents in the U.S. and Europe. DiaGenic is listed on the Oslo Stock Exchange. For more information visit www.diagenic.com ends For more information: Amanda Hayhurst, Hayhurst Media 020-8487 3788; mobile: 0772 0205581; amanda@hayhurstmedia.com James Mackay, Opaldia, 020-7554 4045; mobile: 07894 200460; james.mackay@opaldia.com Issued on behalf of Opaldia Ltd 27 Fitzroy Square, London, W1T 6ES.
BREAST CARE AWARENESS MONTH SEES FIRST PERSONALISED PROGRAMME	Oct 15, 2007

Breast Care Awareness Month Sees First Personalised Programme A new service to make women more aware of breast care and the importance of regular checks is being launched by the United Kingdom’s leading private genetic health service provider, Opaldia. To coincide with Breast Cancer Awareness month, Opaldia’s personalised breast care programme offers the latest recognised best practice cancer screening services, supported by risk assessment and breast cancer information. The programme is also designed to help women make informed decisions on their breast cancer concerns, throughout their lives. James Mackay, Opaldia’s Medical Director said: “Many of our patients worry about their risk of developing breast cancer. In the UK we have an excellent NHS breast screening programme which currently starts at the age of 50. “However, there are greater numbers of women developing breast cancer below that age. They may also have concerns if there is a family history of breast cancer. “Under our programme, we can support a woman as early and for as long she wishes. Our hope is that women will see Opaldia as a partner for life, providing them with the very latest validated advances in breast care and health management services.” The Opaldia service is provided at private hospitals or clinics accredited for breast screening services. Programmes are led by professionals who are expert in the fields of cancer screening, diagnostics, surgery and treatment. Opaldia also provides the best available information produced by Cancerbackup, the UK's leading cancer information charity. Opaldia staff can also be contacted by telephone and email. They will be happy to provide additional support and reassurance. ENDS Notes to Editors · Opaldia is a UK based, healthcare and bioscience company that provides genetic medicine services including, patient screening clinics for inherited disorders particularly cancer; genetic information services and the latest proven molecular diagnostic testing for cancer.. · More information is available at www.opaldia.com For further information on Opaldia, please contact: James Mackay Medical Director, Opaldia t. 0207 554 4052 Amanda Hayhurst Hayhurst Media t. +44 (0)208 487 3788 e: amanda@hayhurstmedia.com w. www.hayhurstmedia.com
OPALDIA HOSTS FIRST IN A SERIES OF GENETICS IN GENERAL PRACTICE EVENTS	Oct 09, 2007

OPALDIA HOSTS FIRST IN A SERIES OF GENETICS IN GENERAL PRACTICE EVENTS A programme aimed at giving GPs the very latest information about genetics and genetic developments relevant to general practice has been launched by Opaldia, the UK's leading private provider of genetic medicine and lifetime wellness programmes. The first Genetics in General Practice seminar was held at the Royal College of General Practitioners and covered discussions on breast, ovarian, bowel and prostate cancers. Opaldia’s medical director and Consultant Clinical Genetic Oncologist, Dr James Mackay, outlined the past, present and future of cancer genetics. Dr Andrea Pithers deputy medical director and former GP said: “GPs have busy workloads, and keeping up to date with the latest developments in genetic medicine is not easy. We at Opaldia are keen to develop a relationship with the primary care sector by providing accessible, up to date information and news on this complex subject. “ ENDS Notes to Editors · Opaldia is the first healthcare company in the UK to provide a complete private genetic medicine service embracing patient screening clinics for inherited disorders particularly cancer; genetic information services; the latest proven molecular diagnostic testing for cancer; and R&D and clinical trials co-ordination to help advance this exciting field of medicine. · More information is available at www.opaldia.com This press release distributed for Opaldia by AR Communications Ltd. For further information on Opaldia, please contact: Alan Rustad AR Communications Tel: 0870 321 7557/07976 722726 E-mail: info@ar-comms.com Website: www.ar-comms.com
AGENDIA’S MAMMAPRINT® BREAST CANCER PROGNOSIS TEST CLEARED BY U.S. FOOD AND DRUG ADMINISTRATION (FDA).	Feb 07, 2007

Agendia’s MammaPrint breast cancer prognosis test cleared by U.S. Food and Drug Administration (FDA). -- MammaPrint^® is the first multi-gene expression test to receive market clearance by the FDA -- Amsterdam, The Netherlands [Wednesday 7 February 2007] Agendia’s MammaPrint^® breast cancer prognosis test is the world’s first In Vitro Diagnostic Multivariate Index Assay (IVDMIA) to acquire market clearance from the U.S. Food and Drug Administration (FDA). Clearance of Agendia’s ‘de novo 510K’ application for MammaPrint^®provides the legal basis for offering this service in the United States. Agendia had previously received clearance from European authorities to market MammaPrint^® in Europe and substantial progress has already been made there in market acceptance and reimbursement. Dr. Bernhard Sixt, Chief Executive Officer at Agendia notes: “The FDA’s focus on the emerging field of molecular diagnostics underscores the growing importance of personalized medicine. Agendia is very pleased that its MammaPrint^®, as the frontrunner in this area, is the first to receive clearance by the FDA. This is not only an acknowledgement of Agendia’s efforts to provide state of the art technology for the benefit of cancer patients, but also sends a clear message to the medical community that our MammaPrint^® test is reliable and clinically useful. In Europe Agendia’s service has already demonstrated its technical robustness and reliability, adding significant clinical value for physicians and breast cancer patients. We are exploring ways to make this product available in the US. We are also confident that the present FDA clearance of MammaPrint^® will help to increase acceptance of this type of technology in clinical decision making for cancer in Europe”. Guido Brink, Director Regulatory Affairs at Agendia comments: “For the last 18 months, we have been working diligently with the FDA to answer the many clinical and technical questions posed by the FDA. And on September 6th 2006, the FDA announced that it planned to assert its authority to regulate this new category of multi-variate diagnostic tests designed to individualize the medical treatment of patients. Agendia’s commitment to comply with the highest quality standards, as reflected in our ISO 17025 accreditation, was a critical asset towards achieving FDA clearance. At present, MammaPrint^® is the first cleared IVDMIA which can be marketed in the US in compliance with these new FDA guidelines.” *About MammaPrint^®* MammaPrint^® is a DNA micro array-based in vitro diagnostic laboratory service that measures the activity of 70 genes, providing information about the likelihood of tumour recurrence. The MammaPrint^® test measures the level of expression of each of these genes in a sample of a woman’s surgically-removed breast cancer tumour and then uses a specific formula or algorithm to produce a score that determines whether the patient is deemed low risk or high risk for spread of the cancer to another site. The result may help a doctor in planning appropriate follow-up for a patient when used with other clinical information and laboratory tests. *About Agendia* Agendia, located in Amsterdam, the Netherlands, is a world leader in gene expression analysis-based diagnostics with three products on the market. The company focuses on the development and commercialization of diagnostic tests using tumor gene expression profiling. Agendia was the first company to commercialize a prognostic test - MammaPrint^® - that predicts the risk of breast cancer recurrence. Agendia maintains close ties with several leading academic centers to develop state of the art diagnostic tests for cancer. Agendia also offers its expertise to pharma companies focusing on development of highly effective personalized drugs in the area of oncology. ========================================================== More information: EU and non-US Media Contact: US Media Contact: Finn Stahlschmidt David Bashaw GCI Mannov Public Relations Ogilvy Public Relations Worldwide Phone: +45 24 62 31 58 Phone: +1 (212) 880-5352 Email: fs@mannov.dk Email: david.bashaw@ogilvypr.com
UK/IRELAND DISTRIBUTOR WELCOMES FDA CLEARANCE OF BREAST CANCER TEST	Feb 07, 2007

7 February 2007 UK/Ireland distributor welcomes FDA clearance of breast cancer test Opaldia Limited exclusive distributor of the Mammaprint^® test, which provides diagnostic data to assess the risk of distant metastasis of breast cancer, welcomes the announcement that Agendia’s MammaPrint breast cancer prognosis test has been cleared by the U.S. Food and Drug Administration (FDA). Chief Executive Elaine Warburton says “this is the first breast cancer micro-array test in the world to be cleared by the FDA and marks a major step forward in identifying whether a women’s breast cancer is likely to return. Doctors and their patients now have the opportunity to find out more detailed information about the breast tumour which should help them to more accurately plan treatment. Opaldia looks forward to working closely with health professionals and patients to improve the standards of personalised clinical care.” Dr James Mackay Medical Director at Opaldia and Consultant Genetic Oncologist at University College London comments; “I welcome this announcement by the FDA which moves oncology clinical care forward in a really significant way. This is the world’s first multivariate analysis test. Mammaprint assesses a number of genetic elements to develop a unique signature which provides information about the biology of the breast cancer”. Professor Karol Sikora, Chairman of Opaldia’s Scientific Advisory Board advises “The Mammaprint prognostic test provides a major step forward towards the goal of directing cancer treatment according to the actual biology of a tumour” ENDS *For further information, please contact Peter Fermoy on* *07984 775059 or Dr. James Mackay at Opaldia Limited on 0207 554 4052.* About Opaldia Opaldia is the first healthcare company in the UK to provide a complete private genetic medicine service embracing patient screening clinics for inherited disorders particularly cancer, genetic information services, cancer screening services and the latest proven molecular diagnostic testing for cancer. Visit www.opaldia.com for more information. References 1. Laura van 't Veer et al., Gene expression profiling predicts clinical outcome of breast cancer, Nature, vol 415, 31 January 2002, 530 - 535 2. Marc van de Vijver et al., A gene expression signature as a predictor of survival in breast cancer, New England Journal of Medicine, vol 347, no 25, 19 December 2002 3. Journal of the National Cancer Institute Vol. 98 No. 17 September 2006. Questions about Mammaprint^® Is this test available on the NHS? The test is not yet available on the NHS but discussions are taking place. What does the test show? This test divides women with breast cancer into 2 distinct groups. In one group the disease has the potential to spread to other organs in the body and therefore chemotherapy is a good management option. In the other group the disease is much more likely to be cured by surgery alone and therefore chemotherapy may not be necessary. What is the evidence for this claim? The evidence is derived from an initial study performed in the National Cancer Institute in Amsterdam. This study was then replicated in five European centres and was published in the Journal of the National Cancer Institute September 2006. How is the test done? A small sample of the breast cancer is sent to Amsterdam in a special container and the sample is analysed in Agendia's laboratory. A report is sent to Opaldia where Dr. James Mackay provides a comprehensive clinical report to the patient and their oncology team. How can it be accessed? The clinical team treating the patient can contact Opaldia on 0870 803 1234 or email info@opaldia.com. Arrangements can be made for the test to be made available to the clinical team within 24 hours. The results and medical opinion are made available to the treating doctor typically within 10 days of receipt of the sample by the Agendia laboratory. Is the test covered by private medical insurance? Some private health companies recognise this test but individual cases usually have to be discussed with the patient’s clinician.
OPALDIA AGREE AN EXCLUSIVE LICENSE WITH AGENDIA	Jan 05, 2007

Agendia BV Announces A Distribution Agreement With Opaldia To Introduce Its Validated MammaPrint(R) Breast Cancer Test And CupPrint Cancer Of Unknown Primary Test In The United Kingdom AMSTERDAM, March 30 /PRNewswire/ -- Agendia BV (Amsterdam, The Netherlands) and Opaldia Ltd. (UK) announced today that they have reached an agreement for distribution of MammaPrint(R) and CupPrint(R) in the United Kingdom. MammaPrint(R), which has been validated, uses a 70-gene profile to classify breast cancer patients as 'low' or 'high' risk of developing distant metastasis in a 10-year period. MammaPrint(R) therefore offers additional information to oncologists and patients concerning the subsequent treatment plan. Breast cancer accounts for almost one in three of all cancer cases in women, and the lifetime risk for breast cancer in women is one in nine. Men can also get breast cancer but it is rare - around 300 cases are diagnosed each year. The CupPrint(R) test is intended for Cancer of Unknown Primary patients. For these cases finding the primary tumour and therefore providing most appropriate treatment is difficult by conventional techniques; this test identifies the primary tumour reliably which helps the oncologist find the best treatment with the objective of increasing life expectancy and reducing chemotherapy's side effects. Agendia believes that CupPrint(TM) represents an important advance in the diagnosis of this challenging group of tumours About Opaldia Opaldia is the first UK company to provide a fully comprehensive genetic medicine service including molecular diagnostic testing and screening and information services for inherited disorders including cancers. With a staff of highly experienced genetic medicine practitioners and an Advisory Board comprising some of the UK's key cancer specialists, Opaldia is leading the introduction of validated genetic tests in the United Kingdom, opening the gates to bringing the concept of personalised medicine a step closer to reality.