| OPALDIA TO LAUNCH BREAST CANCER BLOOD TEST IN 2008 - NEWS | Dec 14, 2007 |
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| OPALDIA RESPONSE TO NEW BREAST CANCER GENES DISCOVERY | May 29, 2007 |
Opaldia response to new breast cancer genes discovery New research led by Cancer Research Dr. James Mackay, Medical Director of Opaldia Ltd says: “This is an important study which furthers our understanding of genetic susceptibility to breast cancer.” “Opaldia can offer women a breast cancer risk assessment today, along with access to our high quality breast cancer screening programme.” Our Service Opaldia offers women a personalised breast care programme; the first in the This includes risk assessment and a high quality annual breast screening programme. The cost of our breast care service depends on the patient’s choice of personalised programme. Prices start from £125. Further information To make an appointment or to request further information on our services, please call 0870 803 1234, email: info@opaldia.com Opaldia Limited Tel: + 44 (0) 870 803 1234 Fax: + 44 (0) 870 803 0999 |
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| A NEW TEST (MAMMAPRINT®) PREDICTS WHETHER BREAST CANCER WILL RETURN | Mar 12, 2007 |
A new test predicts whether breast cancer will return
By PAT HAGAN
12th February 2007
A new test that predicts the likelihood of some forms of breast cancer returning could save thousands of lives.
The test, which costs £1,600 per patient, analyses the activity of certain genes within a tumour.
It then forecasts how likely it is the cancer will come back within the next ten years.
Experts hope the new technology, called MammaPrint, will help doctors pinpoint women whose cancer will return despite surgeons having removed all cancerous tissue.
These patients could then be monitored more closely, or given a course of chemotherapy to make sure any hidden cancerous cells are destroyed.
Around 40,000 women a year in Britain are diagnosed with breast cancer. The disease affects one in nine women at some point in their lives.
Treatment normally begins with surgery to cut out the tumour.
Doctors then decide whether chemotherapy is needed, basing their decision on the size of the lump, how aggressive it is and whether it has spread to the lymph nodes - glands under the arm that help to filter fluid back into the bloodstream.
In around 20 per cent of cases, the cancer is so small and slowgrowing that doctors decide the only treatment needed is surgery. But it is estimated that one in ten of these women have cancerous cells that avoid detection and eventually start growing again.
'There are some cancers that, by the time the surgeon has removed them, have simply "got away",' says Dr James Mackay, a cancer specialist from University College London and managing director of the test's UK distributor Opaldia Ltd. 'A few cells have escaped and already spread to other parts of the body.'
Although scans may show the disease has not spread to major organs such as the liver, tiny colonies of cancerous cells may be hiding. These have the potential one day to grow back into tumours.
It is hoped the MammaPrint test could identify these women at an early stage. 'We hope it will help doctors pick out the small number of women for whom they should go the extra mile with treatment,' says Dr Mackay.
As it predicts how a tumour will behave, it may also save some women from enduring chemotherapy if they do not have to. Some women are currently given the treatment because doctors want to be on the safe side, even though it's unlikely they need it.
The test, developed by Dutch firm Agendia, works by focusing on the profile of 70 specific genes. These were chosen from an initial selection of more than 3,000 genes that are all involved in tumour growth.
By studying the 70 genes, scientists can build up a picture of how the tumour is likely to behave and the chances of it secretly spreading throughout the body. This is because the genes provide vital clues on the biological make-up of each individual cancer.
Within an hour of the surgeon removing the cancer, a sample is stored in a special container and shipped to Agendia's laboratories in Amsterdam. The genetic analysis takes ten days to complete because the tissue is tested three times to ensure accurate results.
Patients are then given either a 'good prognosis' or 'bad prognosis'. If it's good, doctors may decide to spare her chemotherapy. If it's bad, she would be given the toxic treatment, even if there are no obvious signs the cancer is still in her body.
The NHS is expected to follow a recent decision by the U.S. Food and Drug Administration to approve the use of the test. But it is already available in a number of private hospitals.
Professor Karol Sikora, a cancer expert at Hammersmith Hospital in London, said: 'This test could potentially save lives. It can tell us things about a cancer that a pathologist cannot see just by looking at it.
'But it could also spare large numbers of women from chemotherapy if they don't really need it. For some, chemotherapy is a waste of their time and NHS money.'
Cancer Research UK welcomed the test, but stressed that the number of women who will benefit is relatively small.
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| 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 (AR Communications) 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.
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| OPALDIA LINKS UP WITH THE NUFFIELD HOSPITALS TO OFFER GENETIC SERVICES IN THE SOUTH EAST | Jan 05, 2007 |
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Opaldia In The News
