Darmstadt, May 20th 2022
In the case of cancer, the time of diagnosis plays an important role, because the earlier a tumor is detected, the better the chances of recovery are, as a rule. While screenings for the early detection of 5 different types of cancer are regularly offered in Germany, there are numerous other types for which no examinations can currently be offered. The PanTum Detect® blood test could help here.
A large-scale, multicenter, prospective performance study at the University Medical Center Hamburg-Eppendorf (UKE) shows: More than 82% of cases in which the PanTum Detect® provided evidence of cancer or a precancerous lesion at high risk of degeneration were confirmed by follow-up imaging studies. More than 5,000 asymptomatic subjects aged 50 to 70 years with no suspicion of cancer participated in the study. The tested method combination of PanTum Detect® blood test and downstream imaging (MRI and/or PET/CT) provided early detection of 29 different cancer types within the study.
In order to detect precancerous lesions and cancer at an early stage, imaging methods such as MRI and PET/CT are generally well suited. However, they must not be used without concrete suspicion of cancer. The reason for this is, for example, the comparatively low incidence of cancer in symptomless individuals, which does not justify the high costs and radiation exposure. Whether the PanTum Detect® blood test provides sufficient suspicion for the presence of potentially malignant tumors that can be confirmed by imaging and thus justifies the use of imaging techniques – this question was the focus of the performance study with 5,064 participants. These were all aged 50 to 70 years and had neither symptoms nor a personal history of cancer. 57% of the probands were women and more than three quarters had a positive family history of tumor disease.
The methodology: How the blood test works
The PanTum Detect® detects special enzymes in the macrophages in the blood, which are produced more frequently in the early asymptomatic stages of many tumors. The enzymes are called TKTL1 and DNaseX (Apo10). TKTL1 plays a role in glucose metabolism and is present in higher concentrations in many cancer cells. DNaseX (Apo10) is involved in the programmed cell death of damaged cells and is usually present in higher concentrations in cancer cells whose cell death is disturbed.
The study results at a glance
In 4,878 study participants (96.3%), the test results were negative, i.e. there was no indication of a possible cancer. In 3.7% of the study participants, however, the PanTum Detect® provided positive results.
- In 151 individuals with positive PanTum Detect® results, imaging was subsequently performed to clarify the suspected cancer diagnosis.
- In 124 of the 151 individuals, the suspicion of a potentially dangerous tumor was confirmed by imaging. Thus, the blood test provided a correct indication of cancer or a precancerous tumor with a high risk of degeneration in more than 82%.
- In the other 27 individuals, imaging localized a benign tumor in 18. Only in 9 individuals there was no evidence of tumor disease on imaging.
- The 124 true-positive results were divided into 27 cases with suspected malignant tumors and 97 potentially dangerous, i.e., morphologically abnormal tumors.
- In 27 individuals, imaging revealed possible malignant tumors at 15 sites.
In total, the combination of PanTum Detect® blood test and imaging methods allowed the early detection of 29 different types of cancer in asymptomatic study participants.
Conclusion for practice
The combined use of PanTum Detect® and imaging methods such as MRI or PET/CT holds great potential for the early detection of cancer and could set new standards in the diagnosis of tumor diseases in the future.
About Zyagnum: The Darmstadt-based biotechnology company Zyagnum AG develops diagnostic solutions for human medicine. Zyagnum has a profound understanding of immunological processes and their connection with diseases. For example, the EDIM® technology developed by Zyagnum can be used in blood tests to detect specific antigens in immune cells that may play a role in tumour development. Today, the company employs more than 40 people and was founded by Zyagnum CEO Ralf Schierl together with Johannes Coy in 2007.
About EDIM®: When the human organism derails and runs towards disease, the immune system is often the first to recognise this, often before any symptoms. The platform technology we have developed, EDIM® (Epitope Detection in Monocytes), uses the mechanisms of the immune system to detect such derailments. The EDIM® technology examines macrophages for antigens that have previously been taken up into the cell interior by these immune cells through phagocytosis – this is why we also call EDIM® an immunological biopsy.
About PanTum Detect®: The PanTum Detect® is based on EDIM® technology and detects the enzymes TKTL1 and DNaseX (Apo10) in macrophages. A large-scale study at the University Medical Centre Hamburg-Eppendorf was able to show that the PanTum Detect® can provide the decisive indication as to which people without typical symptoms and suspected cancer in a healthy screening benefit from further examination by imaging procedures. In the case of the 2022 study, a previously undetected cancer or precancerous lesion was detected in 124 subjects out of more than 5,000 study participants – from 29 different tumour types in the study alone (Positive Predictive Value: 82%).