Blood test for breast cancer

HeiScreen – medicine experts for tumour diagnostics and cancer tests

Press Material Press Material
Heidelberg, den 29.Mai 2019

Stellungnahme der HeiScreen GmbH Geschäftsführung

In verschiedenen Berichterstattungen wurde der Eindruck erweckt, es existiere bislang kein Bluttest für Brustkrebs. Der Eindruck ist falsch.

Hierzu stellt die Heiscreen GmbH wie folgt fest:

  • Es gibt einen Bluttest für Brustkrebs, der unter Laborbedingungen im Universitäts Klinikum Heidelberg bereits funktioniert und in der klinischen Forschung angewendet werden kann.
  • Ein Prototyp-Kit wurde im Rahmen einer Machbarkeitsstudie entwickelt und inzwischen befindet sich dieser im Stadium der analytischen Verifizierung.
  • Aktuell werden Studien in den Bereichen Eierstock- und Brustkrebs durchgeführt. Die laufenden Forschungsstudien sind noch nicht beendet. Die Patientenrekrutierung für die Studien ist offen.
  • Die Marker, die dem zu entwickelten Test-Kit der Heiscreen GmbH zugrunde liegen, wurden im Labor im Rahmen verschiedener Studien und auch in unterschiedlichen Arbeitsgruppen mehrfach nach Standard SOP’s getestet. Dazu wurden inzwischen über 3000 Proben untersucht.
  • Analysen im Rahmen der wissenschaftlichen Ausarbeitung einiger Studien werden im Forscherteam zur Zeit durchgeführt.
  • Gleichzeitig werden die Arbeiten bezüglich der Überführung des Testes vom Labor auf eine massentaugliche Plattform seitens der HeiScreen GmbH fortgesetzt.
  • Dazu befindet sich die HeiScreen GmbH zur Zeit in der Planung von zusätzlichen klinischen Multizenter-Studien.
Description

Explanation of the procedure

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 cancer cases.

The University Women's Hospital at Heidelberg University Hospital has developed a new method that enables the detection of breast cancer. The test thus complements the diagnostic spectrum of optical diagnostic procedures such as mammography, ultrasound or MRT. Now this test is to be transferred by HeiScreen into clinical application. The market launch of the test for the detection of breast cancer is planned for later this year.

"The blood test developed by our team of researchers offers a new and revolutionary opportunity to detect breast cancer quickly and non-invasively using biomarkers in the blood."

- Professor Christof Sohn, Managing Medical Director of the University Women's Hospital in Heidelberg

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. In the blood of women suffering from breast cancer, 15 different biomarkers were identified that can be used to detect even small tumours.

Only a few millilitres of blood are needed for the test, which any laboratory should be able to perform. The new blood-based procedure is significantly less of a burden on women because it is neither painful nor associated with radiation exposure.

The test can be performed on women of all ages. The latest study results show an overall sensitivity of 75 percent. Sensitivity indicates the percentage of patients actually detected by the test. Age-dependent differences were discovered: sensitivity of 86 percent for the under-50s and 60 percent for the over-50s. Younger women under 50 years of age and women 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 methods are contraindicated due to other risk factors, benefit in particular. Here a sensitivity of 80 to 90 percent was achieved.

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 show a sensitivity of up to 80 percent.

Advantages

Advantages of modern blood-based cancer diagnostics

  • Patient-friendly method for diagnosis of breast cancer

  • Advanced diagnostics for risk groups

  • Possibility of therapy monitoring

  • Possibility of identifying response to therapy or resistance to therapy

  • Options for aftercare

Process

Simple blood test for laboratories

  • Only small amounts of blood needed for detection of breast cancer

  • Diagnosis of cancer on the basis of biomarkers

  • Basis for assessment of cancer risk

  • Adds to range of optical diagnostic procedures such as mammography, ultrasonography and MRI

Research

Innovation from Heidelberg

The scientific research into the blood test for breast cancer was carried out at the University Women's Hospital, a department of Heidelberg University Hospital. The University Hospital Heidelberg is one of the largest medical centres in Germany; the Medical Faculty of the University of Heidelberg 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.

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Press Material

Press material from the press conference held on February 21st 2019.

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