The new IVDR

The new IVDR (In-vitro Diagnostic Medical Device Regulation) has been in force since 26 May. As a result, numerous companies have had to adapt their approval processes and internal procedures. The new regulations also present oncgnostics with new challenges. For example, the molecular biological cancer tests now fall into the second highest risk level. This means that significantly more requirements have to be met. 

What is the IVDR?

The In Vitro Diagnostic Medical Device Regulation, IVDR for short, is an EU regulation that replaces the previous directive, the In Vitro Diagnostic Medical Device Directive (IVDD). Thus, the IVDR regulates the general safety and performance requirements of in vitro medical diagnostics devices within the European Union. Although the new regulation has already existed since 25 May 2017, it is now mandatory after a five-year transition period. For many companies, the new requirements mean major changes.

The most important changes (selection)

The introduction of the new IVDR is accompanied by several changes. The aim of the new regulation is to improve patient safety.

  • New classification of products into four classes: There are risk classes, ascending from A to D.
  • Common specifications: The EU Commission defines common specifications.
  • UDI system: With the help of the Unique Device Identification, UDI for short, the traceability of each product from the patient via the doctor back to the laboratory is to be guaranteed.
  • Every manufacturer of an in-vitro diagnostic product must install a QM system.
  • Technical documentation: especially the requirements for technical, analytical and clinical performance data have increased in scope.
  • Software: The IVDR now formulates specific requirements for products that contain software.

What the new IVDR means for oncgnostics GmbH

oncgnostics launched GynTect, the screening test for cervical cancer, back in 2015. At the time, this was possible with a CE IVD approval through a self-declaration of compliance. In addition, GynTect fell into the “other” category under the previously valid directive. In the new IVDR classification system, GynTect now falls into the second highest risk level “C”. As a result, the conformity assessment procedure has to be carried out with the involvement of a Notified Body. For products that have already been approved, this means that this must take place in four years at the latest. The same applies to the ScreenYu Gyn test, which was approved only recently, in May 2022.

Patient and Physician -PCR test detects cervical precancerous lesions

Jena, Germany, May 25th 2022 – May 28 marks the 35th International Day of Action for Women’s Health. One “female” disease that should no longer exist due to the availability of modern cancer-screening methods is cervical cancer. One step in the direction of abolishing this form of cancer has been taken by the German life science company oncgnosticsIt has namely developed a cancer-screening test called “GynTect”, which can predict whether cervical cancer will develop in a female‘s body.

What happens if the standard gynecologist cancer-screening[1] procedure ends in a positive result, indicating the presence of cancer? Since most abnormalities heal on their own, doctors tend to prefer closely monitoring of the patient and her condition following this test result. They repeat the test after a period of time, leaving these affected women with a highly uneasy feeling of uncertainty.

Cancer test provides certainty for HPV-positive women

By providing women with a clear test result based on real cancer markers, GynTect minimizes this psychologically stressful waiting time for affected women. This test reliably detects changes in the DNA present due to cancer-cell development. As with regular cancer screenings up until now, the gynecologist performs a Pap smear on the patient, taking a swab from the cervix. This sample is then sent to a lab where the PCR-based test is performed.

When GynTect cancer markers are found, women patients need proper and timely treatment. If there are no markers present, these patients can wait with far greater confidence as opposed to fear prior to their next gynecological examination.

“Whereas other lab tests detect HPV or use the microscope to see abnormal cells when analyzing the Pap-test sample, we look DIRECTLY into the cells’ DNA at the molecular level to determine whether cancer-typical changes are found”, says Dr. Martina Schmitz, co-founder and CSO at oncgnostics.

How cervical cancer develops

Cervical cancer almost always develops after an infection involving human papillomaviruses (HPV) and is sexually transmitted. By contrast, other factors such as environmental influences and genetic predisposition play more minor roles.

Compared to other cancer types, cervical cancer can fortunately take years or even decades to develop from an HPV infection. This means that if cancer screening is regularly performed, abnormalities will be found on time.

Regular cancer screening saves lives

Every year about 14,000 women develop cervical cancer[2] and over 5,700 women in the U.S. even die from the disease. Although regular screening is recommended[3], too few women take advantage of it. Some only go to the doctor when they have symptoms. By this time however, this disease can already exist. Resulting treatment can then be long, tedious and psychologically as well as physically exhausting, not to mention much more expensive. For further information and recommendations regarding cervical cancer screening, please go to the website at the American Cancer Society.

“We now have excellent possibilities of detecting cervical cancer at an early stage. Many women can be spared a lot of suffering. Therefore, all women should take advantage of regular screening”, concludes Dr. Martina Schmitz.

 __________________

About oncgnostics GmbH:

oncgnostics GmbH has its headquarters in Jena, Germany and specializes in the early detection of cancer. Their cancer-screening tests reveal changes that are characteristic of cancer-cell DNA. Founded in 2012, the company launched GynTect in 2015. As part of this test‘s ability to detect cervical cancer earlier than other existing tests, it can determine whether cervical cancer or its precursors are present in a woman‘s body. GynTect is officially certified in Europe. oncgnostics GmbH is currently developing diagnostic tests for other types of cancer.

For more information, please visit www.oncgnostics.com/en

For free images, click onto the following weblinks: www.oncgnostics.com/downloads and www.tower-pr.com/oncgnostics

Contact:

oncgnostics GmbH

Löbstedter Str. 41

07749 Jena – Germany

Phone: +49 3641/5548550

pr@oncgnostics.com

oncgnostics@tower-pr.com

[1] https://www.cancer.gov/types/cervical/patient/cervical-screening-pdq#_20

[2] https://hpvcentre.net/statistics/reports/USA_FS.pdf?t=1651740639439

[3] https://www.cancer.org/cancer/cervical-cancer/detection-diagnosis-staging/cervical-cancer-screening-guidelines.html#:~:text=Cervical%20cancer%20testing%20(screening)%20should,test%20alone%20every%203%20years

WHO empfiehlt einmalige HPV-Impfung (xrender/Shutterstock.com)

The World Health Organisation (WHO) recommends the one-dose HPV vaccination of girls and women up to 21 years of age instead of the current two-time vaccination. The WHO wants to increase the vaccination rate in the fight against cervical cancer. In principle, we welcome this plan, but we also have reservations regarding the new recommendation[1].

The fact is, cervical cancer is caused by human papilloma viruses (HPV). While not every HPV infection develops into cervical cancer, there are certain high-risk HPV types. They favour the malignant changes in the cells. There is an effective vaccination against some of these high-risk HPV types. In Germany, the Standing Committee on Vaccination (STIKO) recommends two doses for girls and boys aged 9-14 for sufficient vaccination protection. Those older than 17 should even be vaccinated three times. HPV is sexually transmitted. Condoms do not provide sufficient protection because the viruses are found throughout the intimate and anal areas. For this reason, immunisation is advisable before the first sexual experience.

HPV causes cancer in men and women

It is also a fact that cervical cancer is not the only cancer that can be caused by HPV. In addition to cervical cancer and cancer of the vulva and vagina, an HPV infection can also lead to malignant cell changes in the mouth and throat area, at the anus and also on the penis. Genital warts are also caused by human papilloma viruses. These are harmless, but very unpleasant. Men can not only transmit HPV, but also suffer from HPV-related cancer themselves. In Germany alone, this affects about 1,600 men a year.[2] HPV vaccination also protects against these cancers.

HPV vaccination: useful for girls and boys

Since HPV can cause cancer in both men and women, it is surprising that the WHO focuses its recommendation on cervical cancer – that is, on women. Especially since it also makes sense in the fight against cervical cancer to get boys on board with the vaccination. After all, they can infect their partners with HPV infection as carriers. Since 2018, the Standing Commission on Vaccination in Germany has recommended vaccination against human papilloma viruses for boys aged nine and older.

Dr Cornelia Hösemann (member of the Saxon vaccination commission) takes a very similar view in an interview with the German TV station MDR[3]. In her eyes, the WHO recommendation is a step backwards, because in her opinion, all sexes should be vaccinated from the age of nine. She would like to see a vaccination rate of 80-90 per cent to achieve collective protection. According to a survey by the Robert Koch Institute, the vaccination rate in Germany in 2015 was only around 45 percent[4] among 17-year-olds. This is the age group in which immunisation should ideally already have been completed.

Making HPV vaccination easier – for everyone

The WHO relies on data that show that a single vaccination against HPV ensures full vaccination protection. A single vaccination would mean lower costs, fewer resources, and it would also be easier to administer the vaccination.[5] Thus, access to HPV vaccination would be more low-threshold.

For the time being, the WHO recommendation is only a recommendation. The implementation must be checked by the individual countries themselves. If the vaccination rate can be increased by a simplified HPV vaccination scheme, this is to be welcomed, but then all sexes should be included.

 

Literature sources:

[1] WHO

[2] Robert Koch Institute (RKI)

[3] MDR

[4] Robert Koch Institute (RKI)

[5] WHO

EUROGIN2022-oncgnostics

The EUROGIN is THE event for our current application areas and most of the experts were in Düsseldorf. So were we! With four presentations oncgnostics participated in the scientific discourse at the International multidisciplinary HPV Congress.

The congress was again a great opportunity for us to make new contacts, maintain existing partnerships and exchange ideas about possible new collaborations.

oncgnostics participates in the scientific discourse

Oncgnostics submitted four presentations in the run-up to EUROGIN 2022 and all four were accepted. After a long period of digital-only events, our team was looking forward to receiving direct feedback and exchanging ideas with international colleagues:

 

Dr Alfred Hansel, Managing Director:

“After two long years, we are present again, meeting competitors, cooperation partners, clinicians and scientists. We present our data, discuss them at our booth with all interested parties, also have conversations with chance meetings again.’

 

Dr Martina Schmitz, Managing Director:

“I had the impression that all participants were simply happy to be able to exchange information about the latest studies and results live again after 2 years of the pandemic. GynTect-PRO talk had a good response and our booth enjoyed great interest.”

 

Anna-Bawany Hums, molecular biologist:

“EUROGIN in Düsseldorf has already been worthwhile, as it is the first face-to-face event for me after two years. It’s fun to come into direct contact with interested people at the booth again, to meet existing cooperation partners and to exchange ideas about new projects.”

 

Carolin Hoyer, biotechnologist:

“EUROGIN was my first big conference and I had the opportunity to present my Master’s thesis there, listening to interesting talks and make friendly contacts.”

Contributions of oncgnostics GmbH at EUROGIN 2022

If you were not on site or would like to read the contents, you can download the respective short summaries of the presentations:

 

The business magazine Capital selected Germany’s most innovative companies for the third time. Oncgnostics GmbH made it into the selection. The biotech company scored particularly well in the evaluation criterion of innovation areas.

For the third time, Capital, together with the market research institute Statista, determined Germany’s most innovative companies. For this purpose, they brought around 3,600 innovation experts on board. In a first step, they recommended companies and gave their assessment. In addition, the experts were able to add to their list from 40 innovation competitions of the last three years. The expert assessment covered the areas: “products and services”, “processes” as well as “cultural and social innovations”. Subsequently, 9 categorised reasons for recommendation were assessed. “Regularly delivers innovative products” or “has installed innovation-promoting business processes” are examples of recommendation reasons. The partial results were finally transferred into a 5-star scheme. In total, the experts scrutinised 2061 companies from 20 different sectors. 470 companies received a rating of four or five stars.

Germany’s most innovative companies: oncgnostics gets four stars

oncgnostics received five stars in the innovation category and a proud overall rating of four stars in the “Chemicals, Pharmaceuticals & Biotechnology” sector. In addition, the biotechnology company was identified as a company with a particularly technologically relevant patent portfolio.

List of the most innovative companies

The results of the ranking can be viewed online at Capital.de. We are listed under the 3rd category “Chemistry, Pharmaceuticals & Biotechnology” as one of 8 of the most innovative companies with < 250 employees. You can read all about our innovative product GynTect®, the test for cervical cancer, at www.gyntect.com. You can also find out about our research projects and pipeline products at www.oncgnostics.com.

Cover picture: Shutterstock.com/BB DESIGN STOCK

10 years ago a small, very motivated team founded the oncgnostics GmbH to improve cervical cancer screening. Since then, oncgnostics GmbH has been growing and with it the number of its employees. On the occasion of the anniversary, it is time to share the experiences of the employees of the biotech company.

10 years of oncgnostics – employee from the very beginning

Production manager Dr. Juliane Hippe, head of production, has been with the company from the very beginning. Already as a student she joined the Gynaecological Molecular Biology work group of the Department of Gynaecology and Reproductive Medicine of the Jena University Women‘s Hospital. When oncgnostics GmbH emerged from the working group, the biologist was pleased to receive her first employment contract, a PhD fellowship. In addition, Dr. Juliane Hippe completed her doctorate at the start-up thanks to this fellowship: “I was able to develop steadily at oncgnostics GmbH. In the meantime, I am production manager, but also active in the fields of development as well as quality management.”

Development opportunities at oncgnostics GmbH

Oncgnostics gives its employees room to develop. Dr. Carolin Dippmann was also able to convince through her doctorate at oncgnostics GmbH, also made possible through a PhD fellowship. Nowadays, the Pharma-Biotechnologist is a permanent team member. Now she supervises students herself in their final theses and is responsible for the implementation of new methods in the laboratory. “My greatest motivation is the team, the individuality of each person and how it fits together perfectly to form a whole. I am also motivated by the feeling that our work is making an important contribution within the field of cancer diagnostics,” says Dr. Dippmann, summarizing the motivation behind her daily work as an important member of the Research and Development department.

Likewise, Kristin Knoll completed her master thesis at oncgnostics: “From master’s student to application specialist and head of customer management – I have been able to gain a lot of experience in my almost nine years at oncgnostics. When I look back to the beginning, I am happy to have been involved in product development and also in the growth of the entire company. Constructive criticism and suggestions for improvement are welcome here – that’s how we shape the company together,” says the pharma biotechnologist regarding her career at oncgnostics GmbH.

oncgnostics employees show initiative

Through initiative, the employees of oncgnostics GmbH not only develop further, but most of them joined the team in the first place. Among them Dr. Anne Hennig, who applied on her own initiative: “The role of project manager as well as the management of a research project was awarded to me after a short time.” She draws her motivation from the “fact that you can make a difference with your daily work.”

Master’s student Carolin Hoyer was also successful with her unsolicited application. For her, it is important to “complete my pharma biotechnology studies with practical experience and an exciting project.” These criteria could be met by oncgnostics GmbH.

A varied workplace

The biotech company offers its employees a varied workplace. Anna Bawany Hums, a research assistant, appreciates this: “Even with a lot of office work, I still slip into my lab coat every now and then. There are no rigid structures here. In addition, the working atmosphere is characterized by appreciation.” Technical assistant Kristina Wunsch sees it the same way: “Interpersonal relationships are very important here. There is a considerate way of working together.”

Kristin Knoll, among others, was able to leave her desk behind a few times. As an applications specialist, she has been able to travel to countries such as Portugal, Denmark, Sweden and Azerbaijan. “When time permits, it’s especially nice to catch a few cultural impressions of cultures I’m unfamiliar with,” she says. In addition, the staff members regularly present the current state of their research at various national as well as international congresses.

 

Dr. Carolin Dippmann and Daria Meyer from our research and development team work, among other things, with the “third-generation sequencing” method. With the help of this technology, they are examining DNA (deoxyribonucleic acid) from tumors much more precisely than was previously possible.

The method has enormous advantages: epigenetic changes in the DNA, specifically DNA methylation in certain regions, tell us when healthy cells develop into cancer. And with “third generation sequencing” we can detect these changes directly.

Our goal at oncgnostics is to detect such epigenetic markers. Especially in the early detection of head and neck tumors, development is still in its infancy. In various research projects, including the OroCa-Graz study, we are working together with clinicians on a standardized screening to detect the associated diseases earlier and more reliably than before.

In the following, the two scientists explain to what extent third-generation sequencing is being used and what exactly is behind it.

How does Third Generation Sequencing work?

Part of our daily work is to screen DNA fragments for epigenetic changes, specifically DNA methylation. DNA methylation at specific base sequences indicates that the cell in question has changed.

Third generation sequencing is a method that makes these analyses faster and more effective. In addition, the method provides the DNA sequence information in very high resolution: namely, individual DNA molecules are analyzed. The biological DNA is transferred into a digital version and can be analyzed on the computer. DNA methylation, which occurs during cancer development, can be analyzed directly. And this is of particular interest to us.

The process is illustrated in a video from “Oxford Nanopore Technologies” on YouTube.

How does the method differ from previous methods?

With previous sequencing methods, we could only determine the base sequence of short DNA fragments (300 DNA bases on average). In addition, the DNA to be examined had to be copied several times in advance, very similar to the so-called PCR method explained here. In addition, the DNA had to be chemically treated to detect DNA methylation.

The Third Generation Sequencing method simplifies this process:

  • We can directly evaluate DNA molecules of up to several million DNA bases in length
  • No copies are necessary for this. Rather, we evaluate the individual DNA sequences directly
  • The speed with which we examine the sequences increases accordingly: We now collect the data in real time

What kind of data do we get?

The bottom line is that the Third Generation Sequencing method captures changes in current and records them digitally. It works like this: The DNA to be examined is placed on a surface that is under a specific voltage. Tiny pores made of proteins are embedded in this surface. During the process, the DNA migrates, always in the same direction, through these so-called nanopores. This is why the method is also called “Oxford Nanopore Technology” (ONT).

When the DNA migrates through a pore, the current intensity on the surface changes. This is due to the spatial arrangement and chemical properties of the DNA segments. Sensors measure these changes at each individual pore and transmit them to the computer connected to each. An algorithm then translates the information into the base sequence of the DNA. In the sequence recorded we also read the DNA methylation.

Are there any other advantages or disadvantages?

Since the method is still very new, it has a fairly high error rate. Currently, it recognizes only 95 percent of all sequences without errors. With other methods, the figure is 99.9 percent. Continuous developments will improve this over time. Daria Meyer’s work is part of this. She is a bioinformatician and, as part of her PhD thesis, she focuses on improving the algorithms that are essential for analyzing DNA methylation. In addition, we are constantly optimizing the process flows in the preparation of diagnostic samples. That is Carolin Dippmann’s focus in the project.

In fact, the advantages outweigh the disadvantages. One of the reasons for this is that the analyzer is barely larger than a USB stick and therefore super handy. Theoretically, sequencing can be carried out anywhere, from the Arctic to the desert.

What is our future benefit from Third Generation Sequencing?

With the help of ONT sequencing, major gaps in our knowledge of the human genome (the entire DNA sequence of a human being) have already been closed. We expect further developments in this area. And we are happy contribute to improving the technology.

The biggest advantage for us is the direct readability of epigenetic changes, i.e. DNA methylation. We can analyze these directly at our facility.

The method is gaining acceptance in more and more areas of application. This is not least due to the fact that the initial equipment for starting sequencing projects is very inexpensive. Sequencing of this quality is thus much more affordable. This means that small companies like oncgnostics can also utilize this technology.

Eindrücke vom Jahr 2021 bei der oncgnostics GmbH

We look back on the milestones of 2021 – and forward to upcoming projects.

In May, we moved the entire company within Jena, thus gaining space for more office workspace and a better layout of the labs. Recently, our team grew by one colleague, so that we are now 18 people.

One of the reasons for this was the sales partnership with EUROIMMUN. With our new cooperation partner, we are initially launching GynTect in Portugal, Italy, Turkey, Poland and Canada, with further markets under discussion. Meanwhile, our Spanish partner NIMGenetics aims to expand sales to Brazil and Mexico.

With more personnel and more space our production and QM department is well prepared for the growing international demand.

 

Studies for the diagnosis of head and neck tumors and cervical cancer

Together with the clinical department for general ENT at the Medical University of Graz, we have been conducting research since April as part of the “OroCa-Graz” study to improve and speed up the diagnosis of head and neck tumors.

In addition, we evaluated further results of the GynTect Pro study. The three-year follow-up study included 60 young female patients having a negative GynTect test after an abnormal gynecological finding.

With this study we want to show that these women do not develop cervical cancer despite their abnormal gynecological findings, but that the cell changes heal on their own. We are currently looking at individual follow-ups in more detail and are preparing a publication of the study results.

Continuation of the study on self-sampling: simplifying cancer screening and reaching non-attendees

Following the successful pilot study on cervical cancer screening using samples taken by patients themselves, we continue on this topic in a larger scale. Hannover Medical School is contacting 20,000 randomly selected women from the Hannover region.

They will be given one of three possible options for taking a sample: a special cup for collecting urine or one of two possible self-smear kits. For all women who test positive for HPV, we use GynTect to check whether the self-collected sample indicates that cervical cancer could develop. All HPV-positive women are also referred to the clinic. The aim is to make screening easier in the future.

Participation in conferences

In 2022, we hope to show personal presence in various conferences again. We plan to attend EUROGIN in Düsseldorf as well as the German Cancer Congress in Berlin. At MEDICA, for example, we hope to be able to exchange ideas with representatives of the industry in person again.

Every year, about 7,300 women in Germany are diagnosed with ovarian cancer (ovarian carcinoma), and more than 5,000 die of the consequences. This means that one in 72 women will be diagnosed with ovarian cancer at some point in their lives. In those affected, cells on one or both ovaries change malignantly and begin to grow uncontrollably. Since there is a lot of space around the ovaries where the cancer that develops in this way can spread, many women only notice the disease late. With nasty consequences.

Who is affected?

The risk of an ovarian tumour increases with age. Ovarian cancer occurs more frequently after the age of 50. On average, those affected are 69 years old when they are diagnosed. In addition to higher age, obesity is also an ovarian cancer risk factor.

In addition, the disease can be hereditary and occur more frequently in a family (so-called familial ovarian cancer). Special attention is therefore required if there are known histories of ovarian or breast cancer in the direct family.

Other causes for ovarian cancer may include hormone replacement therapy during the menopause. Women who undergo such treatment are more likely to develop ovarian cancer. However, the risk decreases again if the hormones were taken at least ten years ago.

Women who have had children are also less likely to get ovarian cancer. This also applies to those who took the contraceptive pill or breastfed at least one child during their childbearing years.

Symptoms of Ovarian cancer is often noticed late

Because of their location in the abdominal cavity, ovarian tumours have plenty of room to grow unnoticed. This is why those affected usually have no complaints for a long time.

Suspicious circumstances can be

  • Bleeding outside the menstrual cycle or after the menopause.
  • A larger abdominal girth without gaining weight
  • Bloating, flatulence or abdominal pain, as well as unusual digestive problems that are accompanied by a worsened general condition.
  • Urinating more frequently than normal

If you have any of these symptoms and they persist over a long period of time, you should seek medical advice.

Suspected ovarian cancer: examination and treatment

If a tumour is suspected on the ovaries, they are palpated in a gynaecological examination. In addition, an ultrasound examination through the vagina is often offered. The hit rate here is critical, as tumours cannot be distinguished from other cysts in the ultrasound. If a tumour is nevertheless discovered in the ovaries, its stage determines the further treatment.

According to the FIGO classification (International Federation of Gynecology and Obstetrics), ovarian cancer is divided into four stages:

  • I: The tumour affects one or both ovaries.
  • II: The cancer spreads into the pelvic cavity.
  • III: Outside the pelvis, cancer cells are found in the abdominal cavity or lymph nodes.
  • IV: Tumour cells have spread to other parts of the body outside the abdominal cavity.

Because of the unclear symptoms of ovarian cancer, the disease is often not recognised until stage III or IV. If possible, the treating doctors remove the ovarian carcinoma completely in an operation. This is almost always followed by chemotherapy.

Ovarian cancer diagnosis: good chances of cure if detected at early stage

If diagnosed at an early stage, the chances of cure in the ovarian cancer treatment are relatively good. The relative survival rates after five years are 89 percent in stage I and 77 percent in stage II. The more advanced the tumour, the worse the chances of cure. If the tumour recurs despite surgery and chemotherapy, the disease can no longer be cured, but only treated palliatively.

Good post-treatment care is therefore very important. The actual treatment is followed by close monitoring with regular examinations. Psycho-oncological care or rehabilitation measures can also be useful.

Research project on early detection

At present, there is no special screening test for the early detection of ovarian cancer. In a cooperation with the gynaecological clinic of the University Hospital in Jena, we are researching to find suitable tumour markers for ovarian cancer for improved diagnostics. The aim is to detect the disease earlier and thus increase the chances of cure.

Ask a doctor you trust.

The contents presented here are intended solely for neutral information and general further education. It does not constitute a recommendation or advertisement of the diagnostic methods, treatments or medicines described or mentioned. The text does not claim to be complete, nor can the topicality, accuracy and balance of the information presented be guaranteed. The text is not intended to be a substitute for professional medical advice and should not be used as a basis for independent diagnosis and initiation, modification or cessation of treatment of any disease. If you have any health questions or complaints, always consult a doctor you trust!

 

Literature sources

National Health Service Great Britain (2020): Cancer of the ovaries. www.nhs.uk/conditions/ovarian-cancer

American Cancer Society: Ovarian cancer survival statistics. www.cancerresearchuk.org/cancer-statistics

Center for Disease Control: Ovarian Cancer Statistics. www.cdc.gov/cancer/ovarian/statistics

Zentrum für Krebsregisterdaten (2017): Eierstockkrebs (Ovarialkarzinom). www.krebsdaten.de/Eierstockkrebs

Universitätsklinikum Tübingen: Eierstockkrebs – der stille Feind. www.medizin.uni-tuebingen.de/expertentipps/krebsvorsorge/eierstockkrebs

Deutsches Krebsforschungszentrum (2020): Eierstockkrebs (Ovarialkarzinom). www.krebsinformationsdienst.de

Deutsche Krebsgesellschaft (2018): Eierstockkrebs: Basis-Infos für Patienten und Angehörige. www.krebsgesellschaft.de

As a biotechnology company, we have been researching cancer diagnostics on a molecular basis since 2012. We deal with epigenetic markers, which help us to recognise cancers, such as cervical cancer, in their preliminary stages. In this article, we explain the terms “epigenetics” and “epigenetic marker”.

Epigenetics – what is it?

Epigenetics deals with the heritable, genetic modification of DNA. This happens without the DNA changing within its sequence. The term is composed of two parts: “epi” is Greek for “to” or “above” and “genetics”. Accordingly, epigenetics deals with the level above genetics. For our work, this means that we do not devote ourselves to the DNA sequence that is crucial for coding the genes. Rather, we focus on the chemical change of DNA.

In order to understand what that means, one thing is important to know: Every person has a genome, but many epigenomes – depending on the cell type. The epigenomes, in turn, are influenced and changed by the environment, living conditions or eating habits. Like switches of a cell, they determine which genes or gene segments are used and which are switched off. This explains, for example, why identical twins look different in nuances. Or why only one sibling gets a disease even though both are genetically identical. So-called epigenetic markers are responsible for this at the molecular biological level.

Epigenetic markers show when genes are turned on and off 

Let us stick to the image of the epigenome as a switch that silences parts of a genome. The epigenetic markers are therefore the markings that determine the exact section to be silenced. This takes place, among other things, in the form of methylations. Small molecules, so-called methyl groups, dock to a strand of DNA within the epigenetic marker regions. They prevent a neighboring gene sequence from being read and translated into a protein. The gene segment remains silent.

Epigenetics and cancer

Certain characteristics of the epigenetic changes described above can reprogram the function of cells so that they develop into tumor cells. This is how, for example, cervical cancer develops.

And this is where our research begins. We identify epigenetic markers that occur in cancer, specifically DNA methylation. Our tests should be able to detect these markers as early as possible. Because for every cancer therapy, the sooner it starts, the higher the chances are for a recovery. Our first diagnostic test GynTect® is based on six of these DNA methylation markers. It is already being used successfully in cervical cancer screening.