In Germany, breast cancer is one of the most commonly diagnosed cancer types among women. Approximately 70,000 women have been diagnosed with breast cancer in 2018. This is about 30 per cent of all cancer diagnoses. However, when detected early, there is a 95 per cent probability of being cured. Up to now, mammography screening, MRI, palpation and self-examination of the breast as well as ultrasound are being used for early detection of cancer. Researchers at the University Women’s Hospital in Heidelberg presented a new method for breast cancer diagnostics: A blood test will be used to considerably help improve the diagnosis of breast cancer.
“The blood test developed by our team of researchers is a new, revolutionary method for the non-invasive and rapid detection of breast cancer using biomarkers in the blood,” said Prof. Dr Christof Sohn, Managing Medical Director of the University Hospital in Heidelberg.
Prof. Dr Sarah Schott, head of the Translational Gynaecology Section and head of the Department of Family Cancer, was also jointly responsible for the project. She adds: “The new blood-based diagnosis method is noticeably less stressful for women as it is neither painful nor correlated to radiation exposure”.
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This new diagnosis method is a so-called “Liquid Biopsy”, and it is now possible to diagnose the disease using biomarkers. This way, knowledge about a disease can be obtained from body fluids such as blood, urine or saliva. The messenger substances from tumour cells are being examined using a fluid sample. Only a few millilitres of blood is required for the test. In this test, 15 different biomarkers (miRNA and methylation markers) can be identified with women suffering from breast cancer. These biomarkers can also be used to detect small tumours. The test can be carried out in any laboratory and it expands the diagnostic spectrum of the methods used to date.
The test can be performed on women of all age groups. However, women under the age of 50 benefit in particular. It is also a good alternative for women who fall into a high-risk category when family members have been diagnosed with breast cancer. For these women, mammography provides little information due to the dense mammary gland tissue, or where conventional methods are contra-indicated due to other risk factors. Here, a sensitivity of 80 to 90 per cent could be achieved. The sensitivity indicates the percentage of patients who are actually diagnosed by the test.
DIAGNOSIS OF OTHER TYPES OF CANCER IS BEING RESEARCHED
Heidelberg University Hospital is one of the most important medical centres in Germany. In particular, it is known for its cancer research and therapy. Research into liquid biopsy has been a priority at the University Hospital for many years. In 2016, the scientists registered a patent application for the method used on which this test is based. The first funds were thus obtained. Ever since, the researchers have been working on further developing the method and confirming its accuracy in various investigations.
In the last 12 months, over 900 women were investigated, consisting out of approximately 500 breast cancer patients and 400 healthy women. The study has been designed to test approximately 2,000 participants and will be continued as a multi-centre study. Current results show a total sensitivity of 75 per cent among the 500 breast cancer patients. Age-dependent differences were found: a sensitivity of 86 per cent of the under-50s and 60 per cent sensitivity of the over-50s.
The aim of the ongoing study is to further specify and improve the informative value, sensitivity and applicability through future analyses. They are also researching the use of this method for other types of cancer, such as ovarian cancer. The current interim results reach a sensitivity of up to 80 per cent in the, up to now, approximately 200 patients studied.
PERSONALISED CHEMOTHERAPY POSSIBLE
In addition to the detection of cancer, the blood test can also be used to analyse further data. In the future, biomarkers could also be used to detect metastases or recurrences at an earlier stage. The test could also be used for long-term monitoring. The biomarkers can provide information on whether a treatment responds or whether resistance to therapy occurs. The initial findings suggest that the individual response to chemotherapy can be monitored via Liquid Biopsy, thus enabling a more personalised chemotherapy treatment in the long term.
In order to advance the necessary certifications and to ensure market readiness, the scientists have now founded a company called HeiScreen GmbH. The company’s goal is to advance the market launch of the process and expand its distribution channels. CE certification has already been set in motion, in order to bring the blood test into clinical application before the end of this year.
Photo: Prof. Dr. Sarah Schott und Prof. Dr. Christof Sohn von der Universitäts-Frauenklinik ©Universitätsklinikum Heidelberg
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