Darmstadt, July 14th 2022
- Blood test enables targeted use of imaging for early detection of malignant tumours.
- A high positive-predictive value in the blood justifies clarification via PET/CT or MRI.
- Imaging identifies malignant tumours or premalignant lesions in 82 % of those who test positive in the blood.
- The test will soon be available nationwide in Germany in combination with imaging procedures and a decision on cost coverage.
Darmstadt, July 14th 2022: Zyagnum, a biotech company based in Darmstadt, Germany, has developed a blood test that makes early cancer diagnosis applicable for the screening of a broad population. In combination with imaging procedures such as PET/CT or MRI, Zyagnum’s PanTum Detect® test can detect cancers and their precursors at an early stage with unprecedented accuracy, as a performance study with 5,000 participants at Hamburg’s University Hospital Eppendorf (UKE) has now shown.
The combination of blood test and imaging procedures closes several gaps in early cancer detection. The blood test enables the targeted use of imaging procedures that are otherwise not suitable for comprehensive screening. Combining testing and imaging also provides an effective screening option for cancers for which there are currently no recognised screening methods. If the malignancy is verified, tumour treatment can be initiated much earlier, which usually gives it more chance of success. From autumn 2022, the combination of the PanTum Detect® test with imaging procedures is to be available nationwide in Germany as part of an early detection programme.
Study proves high effectiveness of the combination of blood test and imaging
The high diagnostic efficacy of the combination of blood test and imaging is proven by a prospective, randomised, multi-centre study of the University Medical Centre Hamburg Eppendorf (UKE) under the direction of Prof. Dr. Ralf Smeets and Dr. Simon Burg, which was published in the “Journal of Clinical and Medical Images” in May 2022 . Imaging procedures (PET/CT, MRI) were used in more than three percent of the more than 5,000 healthy study participants from the Hamburg and Darmstadt regions after positive blood test results. In 82 % of the cases – corresponding to 124 people – an asymptomatic, previously undetected cancer or a precancerous lesion was detected. A total of 29 different types of cancer could be detected. The authors of the study sum up: “Our results suggest that the PanTum Detect® blood test could be used as a screening tool and, in combination with PET/CT and MRI, make it possible to detect malignant tumours and premalignant lesions at a stage where there is still a good chance of cure in many cases.” Such a combination thus represents a promising addition to established screening examinations.
Upstream test detects cases that benefit from imaging
Every year, about half a million people in Germany are newly diagnosed with cancer. Treatment is a battle against time. The earlier a tumour is detected and a therapy can be started, the better the chances of cure. Established methods often only detect cancer at the stage of a malignant tumour that has already grown into healthy tissue. In addition, there is no regular early detection for about 55 % of new cancer cases each year. However, the use of imaging measures in healthy people without suspicion and across the board would entail risks, for example due to radiation exposure, as well as high costs. The upstream blood test can identify those people who are most likely to benefit from imaging. Priv.-Doz. Dr. med. habil. G.-Andre Banat, MBA, summarises the applicability of the new findings as follows: “The study results suggest that this combination of PanTum Detect® blood test and imaging procedures can close significant gaps in effective early cancer detection.”
Zyagnum’s EDIM® technology is a key component
Zyagnum’s proprietary EDIM® technology can be used to detect specific antigens in immune cells via blood tests, which can play a significant role in the cancer process independent of tumours. Zyagnum CEO Ralf Schierl holds out the prospect of a comprehensive programme for early cancer detection. “Putting our PanTum Detect® test upstream of an imaging procedure can ensure a suitable pre-screening for effective healthy screening. We are working with suitable partners to make this a reality this year to ensure access, affordability and competent medical support in the event of illness.”
The study publication in the English original can be found here.
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, an indication of a previously undetected cancer or precancerous lesion was provided for 124 subjects out of over 5,000 study participants – in the study alone for 29 different tumor entities (Positive Predictive Value: 82%).