Cancer is and remains one of the greatest health, medical and socio-political challenges of our time. This is also made clear by the World Health Organization’s (WHO) forecast, which predicts a 77% increase in the number of cancers detected by 2050. Of these, cervical cancer is the most common in women between the ages of 35 and 44. Effective cervical cancer screening can actually prevent the cancer, as it is very treatable if diagnosed early. However, current screening tests are too unspecific, sometimes leading to severe psychological stress for those affected and resulting in medical interventions for further clarification, which are often unnecessary. This is where a globally unique test developed in Germany for the reliable and rapid diagnosis of cervical cancer comes in, which Epitype GmbH is now aiming to bring into widespread use.

Cervical cancer – good early detection, inadequate clarification

Cervical cancer (cervical carcinoma) causes 350,000 deaths worldwide every year with 660,000 new cases – and the trend is rising. Despite established screening programs in Germany, 1,500 patients succumb to this particular cancer every year. In 99 percent of cases, it is triggered by an infection with human papillomaviruses (HPV), which can cause cell changes in the cervix. Although there is a reliable test for these viruses, an infection with HPV only very rarely leads to the development of cervical cancer. In fact, almost everyone is infected with HPV at least once in their lifetime – but in most cases the infection is so harmless that it is not even noticed. And even if HPV leads to cell changes – which are quite common in younger women – they usually disappear completely.

Cervical cancer only develops in very rare cases if the infection persists for years and the cells on the cervix change permanently. These precancerous stages can ultimately develop into cervical cancer. In addition to the HPV test, which only indicates whether an HPV infection is currently present, the Pap test is therefore currently the main form of cervical cancer screening. This examines the actual cell changes on the cervix. A swab sample from the cervix is examined under a microscope, which allows signs of precancerous cervical lesions – i.e. degrees of cell change – to be identified. Such a conspicuous test result enables early treatment on the one hand, but on the other hand often leads to a great deal of psychological stress for patients – even though such a test only detects an existing cell change, but not cervical cancer. The time until the next regular examination becomes a real ordeal for many of those affected.

If the Pap test even detects an advanced cell change, the results need to be clarified. This usually means an unpleasant, sometimes painful surgical procedure: a colposcopy, a cervical endoscopy, often involves the removal of tissue for further examinations and, in the case of conizations, conspicuous pieces of tissue are removed directly from the cervix. In addition to the stress that such surgical procedures entail anyway, conizations are also responsible for a fourfold increase in the probability of premature births in subsequent pregnancies.

Worldwide unique test for cervical cancer

Due to this unsatisfactory situation in the diagnosis of cervical cancer, researchers Dr. Martina Schmitz and Dr. Alfred Hansel set themselves the goal of working with their team to develop new tests for the diagnosis of cancer that are fast, safe and non-invasive. “We considered and still consider this situation of psychological and physical stress for women with abnormal test results to be unbearable. Every affected woman should have immediate and reliable certainty about this serious issue,” says Dr. Martina Schmitz. Dr. Alfred Hansel adds: “We want to protect women from these negative experiences and have developed a test that detects cervical cancer and its precursors at an early stage, but also reliably excludes them in other cases.”

The GynTect® test developed is based on the detection of characteristic epigenetic changes in cancer cells. These are changes that influence the gene activity of the cells without causing changes to the DNA sequence itself. Rather, these are so-called DNA methylations, i.e. methyl groups that attach themselves to the DNA. Due to their specific characteristics in cervical cancer cells, these act as highly informative biomarkers with which cervical cancer and its precursors can be quickly and reliably detected or even ruled out. These patented epigenetic markers are suitable for a wide range of applications, from early detection and treatment decisions through to aftercare.

No surgical intervention is necessary for the GynTect® test. As with the Pap test, a swab sample from the cervix taken by the gynecologist is sufficient. In the laboratory, the GynTect® test is used to examine the DNA of the cervical cells for epigenetic changes. This allows a precise distinction to be made between cell changes that heal on their own and those that can develop into cancer. The test result is available within a few working days and can be transmitted by the doctor. Based on the available study data, GynTect® is suitable for making a clear statement on the disease status of patients with an abnormal Pap smear. In studies to date, the test has identified 100 percent of all cervical cancer cases.

Significance and potential for patients and the healthcare system(s)

The GynTect® test is a reliable and gentle, non-invasive method of diagnosing cervical cancer, which quickly provides certainty for those affected and thus significantly reduces psychological and physical stress. It can also effectively counteract the problem of overtreatment. In this way, numerous unnecessary conizations, i.e. tissue removal due to an abnormal Pap test, can be avoided. Around 90,000 of these surgical procedures are performed in Germany every year, which fortunately prevent around 10,500 actual cases of cancer. Conversely, however, this means that almost 80,000 conizations are unnecessary – including the burden on the patients, the 23 percent increased risk of premature births and ultimately the inappropriate expenditure for the healthcare system. Added to this are the hundreds of thousands of women who are referred for colposcopy every year following conspicuous HPV and Pap findings. Here, too, it is clear that only a small proportion of these women are actually diagnosed with a relevant precancerous stage or cancer. The majority, on the other hand, showed no dangerous cell changes on the cervix. All in all, annual savings of around 50 million euros in the German healthcare system are currently easily possible through the use of the GynTect® test. Worldwide, the potential for the benefit of patients and in terms of expenditure within the various healthcare systems is in the billions.

The vision: low-burden early detection of cancer worldwide

Dr. Timm Zörgiebel summarizes the vision of the three managing directors of Epitype GmbH as follows: “Our goal is to make a valuable contribution to the elimination of cervical cancer as part of the WHO’s strategy and to spare as many women as possible unnecessary stress in the early detection of cancer with our gentle and reliable tests. As an entrepreneur and employer, we are also committed to developing Epitype into the leading provider of epigenetic cancer diagnostics in women’s health and a safe and growing employer in Germany.”

On the way there, the expansion of the international network and the intensification of political persuasion work are planned, as are the talks already initiated with German health insurance companies. There is a particular focus on participation in scientific studies: on the one hand, large international comparative studies are planned in cooperation with the long-standing Director of Tumor Biology in Heidelberg, Prof. Magnus von Knebel-Doeberitz. In addition, a large-scale study by Prof. Peter Hillemanns from the Hannover Medical School has been applied for next year in order to compare various clarification tests in HPV-positive women with more than 70,000 patients. The results will then form the basis of the argumentation for the German HPV screening program. These scientific activities will be embedded in an intensification of sales activities in Germany, Europe and Asia and later the entry into the US market.

Today, Thursday 16 January 2025, leading German and international players in the field of radiopharmacy from Saxony agree to intensify their collaboration. The aim of the partners from the fields of research, industry and cluster management is to develop radiopharmacy in Saxony into a centre of innovation and expertise in this pioneering field and thus make it more visible internationally. To this end, have joined forces under the name Radiopharmacy Cluster Dresden – nukliD®.

Radiopharmaceuticals are special medicines containing radioactive elements, called isotopes. They offer the possibility of diagnosing and treating tumours in a precise, targeted and personalised way. Unlike conventional therapies, radiopharmaceuticals act directly in the diseased tissue, sparing the surrounding healthy tissue is largely spared. Radiopharmacy is becoming into a key technology in modern nuclear medicine cancer treatment. With the establishment of the Radiopharmacy Cluster Dresden – nukliD®, the Saxon players in this innovative sector have now joined forces to bundle and further expand their potential. nukliD® will promote cooperation between science and industry, advance technical innovations and carry out public relations work. Another important goal is to train and secure highly qualified specialists and to increase the international visibility of Saxony as a business location.

Minister President Michael Kretschmer emphasised: “Saxony is a top location for innovation. This also applies to the field of radiopharmacy. It is good that this special strength and expertise that has grown in the Free State is now being expanded even further with the new cluster. In fact, the growth forecasts for the radiopharmaceuticals market emphasise the enormous potential of this technology here. It is a strong signal and good for patients how all the players involved here in Saxony are working together to advance forward-looking developments.”

Dresden’s Mayor of Economic Affairs, Jan Pratzka, explains: “Over 60 years of radiopharmaceuticals in Dresden stand for continuous growth and innovation. The constant expansion of the site and the growing demand for radiopharmaceuticals emphasise the relevance of this industry. I am extremely pleased that our region, as one of the leading locations for radiopharmacy, is making a significant contribution to people’s health.”

Frank Höhme, Mayor of Radeberg, added: “It makes me very proud that the Dresden-Radeberg region is emerging as a hub in the field of radiopharmacy and is being further strengthened by the Radiopharmacy Cluster Dresden – nukliD®. The fact that the radiance of the cluster can also prove to be a magnet for other companies in this sector is wonderful news for Radeberg and gives us great hope for the future. Thanks to the cluster, Radeberg can also attract more attention as a business location and as a place to live and be associated with more than just beer. This is a great opportunity.”

The founding members of the network include:

ABX advanced biochemical compounds GmbH, ABX-CRO advanced pharmaceutical services Forschungsgesellschaft mbH, CUP-Contract Labs, Gamma Service Recycling GmbH, Helmholtz-Zentrum Dresden – Rossendorf e. V., Isotope Technologies Dresden GmbH, MDG Molecular Diagnostics Group GmbH, ROTOP Pharmaka GmbH and TRIMT GmbH.

The nukliD® network is coordinated by biosaxony Management GmbH, soon to be leap:up GmbH. CEO André Hofmann emphasises: “With nukliD®, we are not only creating a platform that brings science and industry closer together, but also ensuring that key aspects for the future of radiopharmacy are coordinated and driven forward. This includes the targeted education and training specialists, who are key to the sustainable development of this field. At the same time, we are stepping up our public relations work in order to raise public awareness of the importance of radiopharmacy and are expanding our cooperation with public bodies such as regulatory authorities and ministries. Through this comprehensive coordination, we are creating the basis for mastering technical challenges – such as securing the production of radionuclides – and further expanding Saxony’s competitiveness. Our goal is to establish Saxony as a pioneer and driver of innovation in radiopharmaceuticals.”

Statements from individual players:

Jens Junker, Managing Director of ROTOP Pharmaka GmbH:

With the nukliD® network, we are providing an important boost to for radiopharmacy in Saxony. The bundling of expertise from research and industry not only strengthens the innovative power of our industry, but also the visibility of this important field. nukliD® offers an excellent basis for utilising synergies and promoting specialists in a targeted manner. ROTOP is proud to be part of this future-oriented network.

Dr. Dirk Freitag-Stechl, Managing Director of CUP-Contract Labs:

Participation in the nukliD® cluster is in line with our mission to support the development, approval and quality control of radiopharmaceutical products. By collaborating with leading players in this cluster, we aim to strengthen regional excellence and drive progress in the treatment of diseases, especially cancer, and help consolidate Saxony’s position as a globally recognised centre for innovation.

Dr. Andreas Kluge, Managing Director ABX-CRO advanced pharmaceutical services:

In recent years, the use of radiopharmaceuticals for diagnosis and therapy has increased significantly, even though these procedures have been used in patients for decades. We at ABX-CRO are convinced that as part of the nukliD® cluster we can represent and support the development opportunities here in Saxony for the benefit of patients all over the world. We want to continue to promote Saxony as a location for research and development of radiopharmaceuticals in order to make the region attractive for skilled workers and to strengthen the economy in the long term. nukliD® offers us the opportunity to get in touch with like-minded companies with similar visions for the future and to promote ideas.

Dr. Wilhelm Zörgiebel, Founder and CEO, MDG Molecular Diagnostics Group GmbH:

The World Health Organisation (WHO) predicts a 77% increase in the cancer cases detected by 2050. Early and accurate diagnoses, followed by effective and targeted therapies, is therefore crucial. Precision medicine offers great potential for this, for example with the groundbreaking concept of theranostics for successful, targeted cancer treatment with few side effects using radioisotopes. The Molecular Diagnostics Group (MDG) and its three high-tech companies BIOTYPE, ROTOP Pharmaka and qualitype GmbH expect far-reaching impulses for research, development and realisation of commercial solutions in the field of radiopharmacy from the alliance of powerful players and partners of the region in the Radiopharmacy Cluster Dresden – nukliD®.

Dr. Gunnar Mann, Member of the Executive Board of Eckert & Ziegler SE and Managing Director of Gamma Service Recycling GmbH and Isotope Technologies Dresden GmbH (ITD):

At our Dresden-Rossendorf site, we manufacture high-tech systems for the production of radiopharmaceuticals and supply them worldwide, as well as providing services for the handling and disposal of radioactive products in cancer medicine. Eckert & Ziegler is investing up to € 50 million in the expansion of this production site. The new buildings, which will be completed in the summer of 2024, will form the basis for the company’s further expansion and will create the foundation for up to 100 additional highly qualified jobs in plant engineering and radiopharmaceuticals in Saxony.

Dr. Jakub Simecek, Co-founder & CEO of TRIMT GmbH:

Our participation in the nukliD® cluster is the logical consequence of founding our modern company in Radeberg, which specialises in radiopharmaceuticals and oncology – a location that is internationally renowned for significant developments in radiopharmaceuticals. We develop innovative drugs for cancer diagnostics and targeted therapies, which we are already using clinically worldwide. The Radeberg/Dresden site offers ideal conditions for this. Together with the other members of the nukliD® network, we will further strengthen the global presence, economic power and attractiveness of the Saxony region.

Dr. Marco Müller, CEO ABX advanced biochemical compounds GmbH:

As part of the newly established Radiopharmacy Cluster Dresden – nukliD®, we look forward to enhanced collaboration with the companies in our network. Radiopharmacy is a key technology in modern cancer treatment and we are convinced that through joint projects and a strong, unified approach we can achieve better patient care. By pooling our resources and knowledge, we can develop innovative solutions that not only revolutionise the diagnosis and treatment of patients, but also make Saxony an internationally visible location. Together with our partners, we are committed to driving technical innovation and educating highly skilled prefessionals to actively shape the future of radiopharmacy. Let’s work together to realise the full potential of this promising technology, says Marco Müller.

Prof. Sebastian M. Schmidt, Scientific Director of the Helmholtz-Zentrum Dresden-Rossendorf (HZDR):

We are proud to play a key role as a strong research partner in the network. Thanks to our application-oriented basic research, we can lay the foundations for the industry to establish the Dresden and Radeberg region as a leading centre for radiopharmacy in the long term.

contact:
biosaxony Management GmbH
Deutscher Platz 5c, 04103 Leipzig
Mail: graf@biosaxony.com
Phone: 0176/10230066

biosaxony Management GmbH, soon to be leap:up GmbH, cluster manager of biosaxony e.V., bundles the strengths of Saxony’s biotechnology, medical technology and healthcare industries. With a clear focus on innovation and the promotion of skills developement, it is a key player in the economic region of Saxony.

Advancements in healthcare are progressing rapidly. Over the past few decades, the average life expectancy has increased by approximately 20 years. However, with aging comes a rise in complex diseases such as cancer, posing significant challenges to society. The Molecular Diagnostics Group aims to address these challenges with innovative developments in precision medicine.

The World Health Organization (WHO) predicts a 77 percent increase in diagnosed cancer cases by 2050. Therefore, early and precise diagnoses followed by effective and targeted therapies are crucial. Precision medicine, with its approach of personalized diagnostics and therapy for patients, offers great potential in this regard. However, making this widely available in routine practice is currently still very complex and expensive, significantly limiting access to precision medicine. The members of the Molecular Diagnostics Group — three high-tech companies, BIOTYPE, ROTOP Pharmaka, and qualitype — are dedicated to the shared goal of advancing precision medicine by developing customized, low-side-effect, and most importantly, cost-effective diagnostic and therapeutic solutions for broad application.

Maximum Efficiency in Molecular Diagnostics

One of the major challenges in healthcare is the often complex and costly process of molecular diagnostics. Traditionally, laboratories have had to perform their analyses using a variety of methods and devices, alongside labor-intensive evaluation and documentation processes. To address this, BIOTYPE has developed the MODAPLEX system, a laboratory device for the automated analysis of molecular biomarker signatures, significantly simplifying this process. Biomarker signatures describe specific molecular changes that, in combination, provide therapy-relevant insights into disease mechanisms.

The MODAPLEX system maximizes the use of available sample material and reduces critical turnaround times. In less than four hours, the automated analysis process delivers reliable laboratory results. During this time, both RNA and DNA biomarkers relevant for decision-making are simultaneously measured from a single sample. Based on this data, the most appropriate therapy can be initiated. These fast and cost-effective multi-gene analyses are crucial for the widespread adoption of precision medicine.

Targeted Theranostics with Radioisotopes

Theranostics is considered a groundbreaking concept for cancer treatment, combining imaging diagnostics at the molecular level of a tumor with targeted therapy for those specific tumor cells. The development of this theranostic approach, which has been clinically tested extensively over the past five years, is at the core of ROTOP Pharmaka’s business activities. As a pharmaceutical manufacturer, ROTOP produces nuclear medicine products for use in both diagnostics and therapy.

Theranostics takes advantage of the characteristic property of cancer cells, which possess specific surface structures. Biotechnologically targeted recognition molecules can be designed for these structures. These recognition molecules can then be coupled with radioactive substances, known as radioisotopes. After being introduced into a patient’s bloodstream, these complexes selectively bind to the corresponding cancer cells. This enables the localization of tumors within the body through imaging diagnostics using the radioisotopes. In therapy, the same cancer cells can be precisely targeted and treated. Unlike other treatment forms that may cause significant side effects, this approach minimally affects healthy tissue.

Consistent Digitalization and Data Integration

Consistent digitalization of processes is essential in precision medicine. Within the Molecular Diagnostics Group, this role is fulfilled by qualitype, a software system provider with a strong focus on the challenges of complex digitalization and data integration in healthcare. Central to qualitype’s vision is the concept of the Digital Patient, meaning that all patient information is digitally collected and processed by qualitype. This comprehensive digitalization helps to support doctors effectively in their decision-making processes.

With the combined expertise of BIOTYPE, ROTOP, and qualitype, the Molecular Diagnostics Group is advancing the development of precision medicine with cost-effective and highly effective solutions for both in vitro and in vivo diagnostics, as well as accompanying therapies.

Further Information:

• Molecular Diagnostics and the MODAPLEX System: www.biotype.de
• Nuclear Medicine Products and Theranostics: www.rotop-pharmaka.de
• Digitalization and Data Integration: www.qualitype.de