Frankfurt Being able to detect cancer as early as possible so that it can still be cured – this desire drives many scientists and companies. So does Ralf Schierl, co-founder and managing director of the diagnostics company Zyagnum from Pfungstadt in Hesse. The company, which has 35 employees, has developed a test that is designed to find clues in a person’s blood as to whether they have or are developing a malignant tumor.
Zyagnum wants to establish the product, which was approved in 2017, as an annual screening test. The company has now come closer to that: With Hanse Merkur, the first private health insurer will pay for the test once a year in the future – even though cancer doctors continue to take a very critical view of the procedure.
If the test has an abnormal result, the insurance company will also cover the costs for imaging diagnostics to find the tumor – including expensive positron emission tomography (PET), which can be used to display metabolic activities in the tissue. Treatment by the chief physician, daily sickness allowance and accompanying care are also part of the “cancer scan” insurance package, for which self-payers pay 19.83 euros per month in the first year and 27.50 euros per month from the second year.
Hanse Merkur decided to launch the insurance product because a study commissioned by Zyagnum at the Hamburg University Hospital Eppendorf (UKE) delivered “convincing results”, as Sales Director Eric Bussert says.
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5,064 adults with no previous cancer were tested with the Zyagnum product. Abnormal blood results were found in 186 subjects. 151 of them agreed to be examined with imaging methods. Malignant tumors or potential precancerous lesions were found in 124, or 82 percent. 27 subjects were classified as false positive, the suspicion of a tumor was not confirmed.
Test showed many tumor diseases
Ralf Smeets, Deputy Head of the Clinic for Oral and Maxillofacial Surgery at the UKE, led the investigation. “The aim of the study was to find out whether the test is capable of filtering out those who have or are developing a potentially dangerous tumor from a group of apparently healthy, symptom-free people,” says the university professor. The test proved that.
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This improves the chances of therapy, according to Smeets. In addition, the test had an impact on many tumor diseases for which there is currently no regular early detection.
For Jutta Hübner, Professor of Integrative Oncology at the University Hospital in Jena, however, the data is not sufficient: “If you want to spread a test as an early detection method, then the clinical benefit must be proven and it must outweigh the risks,” she says. The study did not do that.
“We don’t know how many people in whom the test did not raise any suspicions later develop cancer or even already have a hidden tumor,” said Hübner. In a study on the early detection of cancer, a survival benefit from the test must be demonstrated. “The damage caused by clear psychological stress on people due to unclear test results, on the other hand, is considerable,” says the expert.
The Zyagnum blood test is used in combination with imaging tests.
(Photo: AFP/Getty Images)
In addition, if meaningful results are to be obtained for the various types of tumors, the number of subjects would have to be much higher than 5,000 in their estimation.
The Zyagnum test goes back to the so-called Edim technology developed by the company. It is used to detect certain antigens in immune cells that indicate tumors. According to a statement from October 2021, the German Cancer Society cannot recommend the method for the diagnosis of tumor diseases.
The assessment is based on a systematic literature search of clinical work in which the test was used. It is not a validated method that has been tested in an adequate controlled study, it is said. “Even since then, newly published studies do not change this statement,” says Hübner, who co-wrote the statement.
Conflicts of interest should be taken into account when evaluating publications on diagnostic methods. The company is not aware of any independent studies that have been conducted with positive results, the paper said.
High risk of false positive test results
Michael Neumaier, Head of the Institute for Clinical Chemistry at the Medical Faculty in Mannheim, is also critical of the test procedure. In principle, the biomarkers examined are not specific in the actual sense, as is the case, for example, with the determination of genetic mutations. In addition, there is a high risk of false positive test results when screening for cancer in the healthy population. “It’s a huge psychological burden for those affected,” he says.
“However, it is to be welcomed that Zyagnum wants to make the test more meaningful with downstream imaging diagnostics,” Neumaier told the Handelsblatt. However, he still considers suitable large-scale studies to assess the benefit of the combined diagnostics of blood tests and imaging to be necessary.
In an interview with the Handelsblatt, Zyagnum boss Schierl emphasized that the company took the criticism very seriously. “That’s why we only offer it in Germany with follow-up diagnostics as part of an insurance package,” he says.
The Zyagnum boss emphasizes that the company took the criticism very seriously.
(Photo: Zyagnum)
The cooperation with Hanse Merkur eliminates another of Neumaier’s previous criticisms: that the company booked the profits with the test, but the costs of the follow-up diagnostics were borne by the general public. Now the issue is an insurance and policyholder issue.
Zyagnum and Hanse Merkur have founded a joint company to set up the infrastructure so that the test can be offered nationwide. According to sales director Bussert, Hanse Merkur has invested a seven-digit amount in this company.
According to UKE doctor Smeets, the course of therapy in test persons with tumor disease or precursors should be monitored in the coming years. And the almost 4,900 test subjects in the study who tested negative will be followed up after twelve months to see whether they have developed a tumor disease, i.e. whether they have been tested falsely negative.
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