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HeiScreen GmbH. (2/21/19). "Press Release: Researchers at Heidelberg University Hospital Develop First Marketable Blood Test for Breast Cancer". Düsseldorf & Heidelberg.

Region Region Heidelberg
  Country Germany
Organisations Organisation Heiscreen GmbH
  Organisation 2 Heidelberg University Hospital
  Group University of Heidelberg (Ruperto Carola)
Products Product diagnostic test, breast cancer
  Product 2 liquid biopsy

> Diagnosis using a combination of biomarkers

> Non-invasive procedure for patients

> Test provides additional tumour data

> CE certification process under way

> Market launch by HeiScreen GmbH planned for later this year

> Basis provided by cohort studies at Heidelberg University Hospital

A milestone in breast cancer diagnosis: the University Women’s Hospital, a department of Heidelberg University Hospital, one of the largest centres for cancer research and treatment, has developed a new method of improving breast cancer detection using a blood test. Diagnosis is non-invasive thanks to an innovative liquid biopsy procedure.

The new procedure detects the presence of cancer using biomarkers and thus adds to the range of optical diagnostic procedures such as mammography, ultrasonography and MRI. Fifteen different biomarkers (miRNA and methylation markers) have been detected in the blood of women with breast cancer, which can be used to detect even small tumours.

“The blood test developed by our team of researchers offers a new and revolutionary opportunity to detect cancer in the breast quickly and non-invasively using biomarkers in the blood,” says Professor Christof Sohn, Managing Medical Director of the University Women’s Hospital. Professor Sarah Schott, Section Head of Translational Gynaecology and Head of Familial Cancers, University Women’s Hospital Heidelberg, who heads the project in collaboration with Professor Sohn, adds, “The new blood-based procedure is much less of a burden on women, since it isn’t painful and doesn’t involve exposure to radiation."

Rapid, non-invasive diagnosis

The blood test is based on the liquid biopsy principle. This involves obtaining information about a disease using bodily fluids such as blood, urine or sputum by examining messenger substances from tumour cells in a liquid sample. Only a few millilitres of blood are needed for the test, which any laboratory should be able to perform. The test can be given to women of any age, although it is particularly beneficial to younger women (under the age of 50) and those with a high familial risk of breast cancer, for whom a mammogram would be of limited value because of dense mammary gland tissue, for example, or for whom traditional imaging procedures are contraindicated because of other risk factors. A sensitivity level of 80-90 percent has been achieved with this method. The figure for sensitivity describes the percentage of patients with the disease who are actually detected by the test.

Cohort studies provide basis for product development

Heidelberg University Hospital has been committed to liquid biopsy research for a number of years: in 2016, a patent application was submitted for the procedure underlying the test, and initial grant funds were obtained. Since then, the procedure has become established and refined, and its accuracy has been confirmed in a number of studies. In the past 12 months, a cohort of more than 900 women has been studied, comprising more than 500 with breast cancer and 400 healthy patients. The study is designed for a population of 2,000 and takes the form of a multi-centre study. The latest results show an overall sensitivity of 75 percent for the 500 breast cancer patients. Age-dependent differences have been discovered: sensitivity among the under-50s was 86 percent, compared to 60 percent for the over-50s.

The goal of the ongoing study is to further specify and improve the significance, sensitivity and usability of the procedure through future analyses. Its usability for other forms of cancer, e.g. ovarian cancer, is also being investigated. Current interim results for some 200 patients show a sensitivity of up to 80 percent.

Research and test provide further information on cancer

In addition to detecting the presence of cancer, the blood test can also be used to analyse further data. In future, biomarkers will also be used to detect the development of metastatic and recurring cancers at an earlier stage, and the test will be used in long-term monitoring. The information thus gained will also benefit the treatment itself: the biomarkers can supply information about whether a treatment is working or if a resistance to treatment is developing.

Initial insights also suggest that it is possible to use the liquid biopsy process to monitor the individual response to chemotherapy, and thus lead in the longer term to personalised chemotherapy treatments.

Market launch planned for later this year

To press on with the necessary certification processes and ensure the procedure is market-ready, a spin-off under the name of HeiScreen GmbH. The company will advance the market launch of the procedure and develop the appropriate sales channels. CE certification is already under way, with a view to having the blood test in clinical application before the end of the year.

Breast cancer is the most common form of cancer affecting women in Germany. In 2018, some 70,000 women developed breast cancer, accounting for about 30 percent of all new cancers. The chance of recovery with early detection, however, is very high (95 percent).

Heidelberg University Hospital

Heidelberg University Hospital is one of the largest and most prestigious medical centres in Germany. The Medical Faculty of Heidelberg University is among the most internationally renowned biomedical research institutions in Europe. Both institutions have the common goal of developing new diagnostic methods and therapies and implementing them rapidly for patients.

HeiScreen GmbH

HeiScreen GmbH is a spin-off from Heidelberg University Hospital. With a team of internationally renowned experts, it performs research into cancer diagnosis procedures with a view to establishing them in clinical practice.


Contact us via the website of the new company at

Record changed: 2019-03-26


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