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Nearly two months ago, the Heidelberg University Hospital made headlines in the world press with a "milestone in the early detection of bad cancer". Professor Christof Sohn, Medical Director of the University Hospital for Women, explained: "The blood test developed by our team of researchers is a revolutionary new method of rapid and non-invasive detection of bad cancer at the same time. using biomarkers in the blood. become marketable this year. "
According to the research team of the University of Heidelberg and a subsidiary of HeiScreen University Hospital GmbH, in which two members of the research team are also involved financially, the new method is "Significantly less harmful to women because it is neither painful nor involves exposure to radiation." The fact that the head of the test development team, molecular biologist Rongxi Yang, has left the university hospital in 2017 and that the subsidiary of the university hospital have a stake in Heiscreen NKY GmbH, marketing manager of the test in Asia, was also taken into account.
At the end of March, the hospital pulled back and apologized for the public relations campaign. The reason: HeiScreen GmbH lacked evidence and public results of clinical trials showing that the blood test was working, and information on the number of false positive test results found in healthy volunteers.
A few days ago, the Heidelberg prosecutor's office opened a preliminary investigation after the university hospital filed a criminal complaint against strangers. "As a public institution, the University Hospital is forced to take this step because of signs of an unfair procedure in the development and announcement of the potential blood test." for the diagnosis of bad cancer, presented to the scientific experts and the public on 21 February. "The responsible authorities said in a statement." The university hospital itself "had already taken many steps to cope with the situation: an internal scientific working group and the clinic's internal audit department are in charge. badyze the processes and report directly to the board of directors A commission of neutral external experts is being formed. "
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No substitute for mammography and co.
The test, based on the "liquid biopsy", was designed to detect bad cancer using biomarkers in the blood, urine or saliva, and long-term replace conventional methods such as than mammography screening or MRI. The test is based on the fact that genetic material changes as soon as a healthy cell turns into a cancer cell, which produces specific biomarkers. These biomarkers are located on the surface of the tumor cell and are separated from the surface when the tumor cell is flowing, for example. This allows them to enter the bloodstream and be detected in the blood serum.
In the Heidelberg research project, the blood of healthy women and women with bad cancer was tested to detect the presence of different biomarkers (mainly protein components) present in different forms of bad cancer and for look for typical cancerous mutations.
The detection of these so-called biological tumor markers ("biomarkers") is performed using molecular biology methods. The markers, which have so far been tested on tumor tissue in clinical practice, allow to identify the characteristics of an already diagnosed tumor: they allow, on the one hand, 39, evaluate the malignancy of the tumor and its treatment prospects (= predictive value) and, on the other hand, they provide information on the effectiveness of a targeted therapy (= prognostic value). The status of hormone receptors, which provides information on the use of anti-hormonal therapy, or the status of Her2 receptors, which provides information on a stimulating growth factor for tumor cell division, are examples.
In theory, the new test looks promising, but questions remain as to its general utility. First of all, there is not a single type of bad cancer, but a wide range of biologically different types that are diagnosed at different stages of the disease. "Invasive mammary carcinomas" are in turn subdivided into cbad ducts (concerning the milk ducts), lobular (mammary glands) and other less frequent variants, ductal carcinomas being the most frequent (70 to 80%). In addition, there is the DCIS (ductal carcinoma in situ), an early form of bad cancer in the milk ducts, which has not yet spread to the surrounding tissues (= non-invasive), but for which it there is a risk of development. in cancer (= invasive carcinoma).
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Low probability of detecting cancer cells
The report from the Heidelberg University Hospital gives the impression that blood tests and special molecular biological tests can be used to detect a previously undiagnosed bad malignancy. Without the necessary background information, this might suggest that a tumor cell that pbades into the blood test can be removed and that the tumor can be detected. This misconception is easily refuted: in a blood test, a blood sample of 5 to 10 ml is taken. There are 4 to 5 liters of blood in the body of a woman. It is therefore unlikely that a certain tumor cell pbades exactly at the time of blood collection. Therefore, the probability that cancer cells can be identified as such in a test of this type is very low.
False diagnoses
Although the idea of a blood test, presented by the University Hospital Heidelberg, is excellent in the eyes of many doctors, it must first be the object of a blood test. a thorough test for its practical use. As the university hospital recently confirmed, 30 women were falsely tested positive for bad cancer in 100 exams, while cancer was not always detected in people with disease.
It will take some time before this type of blood test is suitable for general use. However, doctors find it surprising and ethically questionable that a renowned institution such as the University Hospital Heidelberg authorizes a misstep of this magnitude and gives false hope to millions of women by presenting to the public a method insufficiently tested without evidence sufficient.
According to figures published by the German Cancer Society, bad cancer is the most common cancer among women in industrialized countries, accounting for about 30.5% of cases. In Germany, bad cancer is diagnosed in more than 70,000 women and nearly 20,000 die each year.
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Independent
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