Media study:

A recent media study by Oncgnostics GmbH shows that, although the general media report on the topic of cervical cancer, they do not address the associated psychological stress for the women affected. Dr. Martina Schmitz, founder and CEO of Oncgnostics, comments:  “We are surprised that the psychological burden is barely mentioned. The causes and treatment options for cervical cancer are omnipresent. Yet, it still seems to be taboo to talk about the psychological effects. Even an increased risk of developing cervical cancer can be stressful for women.

For over a year, the team examined all editorial publications in consumer media − found via the Google search engine with the keyword cervical cancer. Only one article mentioned suitable contacts for psychological pressure.

Study

From the beginning of January 2023 to the end of March 2024, the Oncgnostics team used the Google search engine to research a total of 162 editorial hits on the topic of cervical cancer, i.e. online publications from daily newspapers, magazines, radio stations and TV reports as well as purely online editorial offices. Advertising texts, such as medical practice websites or knowledge portals like Wikipedia, were excluded. The team then analyzed each article to determine which topics it dealt with, i.e. according to the categories of diagnosis and early detection, causes, HPV vaccination, celebrities, treatment options or psychological stress, whereby several of these points could also apply per article.

Result of the study

A total of 66 articles discussed HPV vaccination, with 37 covering it as a main topic and 29 as a supplementary topic. Early detection of cervical cancer was addressed in 55 articles, 45 of which included it as a main topic. The Oncgnostics team found 46 articles that dealt with celebrities who either developed cervical cancer and spoke publicly about it or died from the disease. 20 articles, or around one in eight, were dedicated to other topics, such as the Indian influencer who faked her own death from cervical cancer. 15 articles focused on treatment options, 12 of which included this as the primary content. 5 articles discussed the causes of cervical cancer, but only one focused on them as its main topic.

Mental stress not addressed

Mental stress was the focal point in one article, which merely mentioned professional personnel, such as therapists, who can be consulted in the event of an illness. Although anxiety was discussed in 18 other articles, these articles were mainly based on statements from participants in documentary soaps like Jungle Camp, and no solutions or recommendations were given. 

Three months of unnecessary mental stress

“Women,” says Schmitz, “suffer psychological pressure from the moment the risk of cervical cancer is mentioned, for example during a routine examination. The stress usually begins when a woman receives a positive HPV test along with a conspicuous Pap smear. Then, the patient must wait at least three months until the test can be repeated. And if this result is still inconclusive, the patient often must wait up to two years for further tests before a clear conclusion can be drawn. This is unnecessary mental torture. Why are women expected to endure many months of uncertainty when a result can be given in three days?”

Two options for rapid diagnosis and thus certainty

Schmitz believes that diagnostic procedures based on cancer-specific DNA methylation are the best way to provide women with a quick result, especially if there’s uncertainty about cervical cancer status.  Schmitz: “There are simple options for around 150 euros that can save women at least three months of psychological stress. But unfortunately, the media don’t talk about this.”

Conclusion

Within the period of January 2023 to March 2024, 162 articles discussed the topic of cervical cancer. 66 of these articles focused on HPV vaccination, while 55 covered the possibilities of early detection. The psychological burden of suspected or confirmed cervical cancer was addressed in just one article, which simply mentioned professional groups such as psychologists. Newer and faster cervical cancer medical options were not mentioned, even though, in Dr. Schmitz’s opinion, these would be the best way to help affected patients and their relatives.

Molekularbiologische Krebs-Diagnostik - oncgnostics auf der MEDICA
  • Two tests for cervical cancer with different objectives in cervical cancer screening
  • Liquid biopsy for rapid and gentle diagnosis of head and neck tumours
  • Current studies: GynTect DNA methylation test more sensitive than cytological examination
  • New investor enables sales expansion in ASEAN countries
  • At MEDICA at the joint booth of medways e.V. in Hall 3, booth G74

Jena / Düsseldorf, November 02, 2023 – oncgnostics GmbH will present its molecular biological cancer diagnostics, its products and current study results at MEDICA, the largest trade fair in the medical industry. Oncgnostics develops patented, highly informative biomarkers. This technology improves existing cervical cancer diagnostics and also, using liquid biopsy, lays the foundation for early detection of head and neck tumours.

Molecular biological cancer diagnostics

DNA methylation forms the basis of oncgnostics’ work. This modification occurs at specific DNA regions when cancer develops or is already present. The tests from oncgnostics detect these changes.

Tests for cervical cancer: improving screening

The screening test GynTect is used in cervical cancer diagnostics and is sold in several European countries and under exclusive licence in China. In China, it is the first DNA methylation test for triage of HPV-positive cases. In Germany and Europe, GynTect closes gaps in the clarification of screening abnormalities through its rapid and reliable results.

ScreenYu Gyn is a further development of GynTect. The screening test uses only one methylated DNA region, whereas GynTect detects six methylated marker regions. This makes ScreenYu Gyn suitable for automation, which allows new areas of application.

Liquid biopsy as the key to head and neck tumour diagnostics

Tumours in the head and neck region are among the five most common cancers worldwide. Nevertheless, there is no established early detection for this type of tumour. Most diagnostic methods are expensive, laborious and involve invasive biopsies. To achieve the goal of an established early detection for head and neck tumours, oncgnostics relies on molecular biological diagnostics using liquid biopsies such as saliva or oral smear samples. The current OncSaliva study is testing the suitability of epigenetic tumour markers for the detection of head and neck tumours in liquid biopsies.

Study: GynTect is more sensitive than Pap test

GynTect detects all cancers, while the cytological examination misses two cases. This was the result of a large-scale study that served as basis for the approval of the test in China. Furthermore, in the study the specificity and sensitivity for detecting high-grade precancerous lesions were also better and equivalent, respectively. Thus, GynTect has a better clinical performance than the so-called Pap test.

Chinese investor enables new opportunities in sales and research

Another strong partner, Hong Kong-based Grande Bio-tech Co. Ltd., invested in oncgnostics GmbH in July. One goal of this partnership is to expand the distribution of the tests developed by oncgnostics in the ASEAN countries.

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About oncgnostics:

Oncgnostics GmbH, a biotech startup spin off from the Jena University Hospital, develops molecular biology tests for cancer diagnostics based on epigenetic changes in the human genome. With GynTect, the company introduced an innovation in the field of cervical cancer screening. Currently, the startup is developing further tests for head and neck cancers. The team of researchers led by founders Dr. Alfred Hansel (CEO) and Dr. Martina Schmitz (CSO) received the Thuringia Innovation Prize twice (2014, 2017) for their diagnostic approach.

 

Free image material: www.oncgnostics.com/downloads

 

Contact:
Ines Sommer
Communication and marketing
Löbstedter Straße 41
07749 Jena, Germany
Tel.: +49 3641/55485 51

pr(at)oncgnostics.com

2023 PM Oncgnostics Investment

Jena, September 05, 2023. The Hong Kong-based company Grande Bio-tech Co. Ltd. is making a seven-digit Euros investment in the Jena-based diagnostic company Oncgnostics GmbH. Oncgnostics has developed the cancer diagnostic Gyntect for the reliable detection of cervical cancer. Since 2022, this test has also been distributed and utilized in collaboration with a local partner in China. Following the successful launch of Oncgnostics’ test in China, Grande Bio-tech Co. Ltd. has decided to make a financial commitment. The goal now is to expand the distribution of tests developed by Oncgnostics in the ASEAN countries. 

Oncgnostics in China since 2022

After years of close collaboration with a Chinese partner, Oncgnostics’ Gyntect test received approval for the Chinese market in 2022. Since then, the test has been used in China under the name GongAnLi. The Hong Kong-based holding Grande Bio-tech Co. Ltd., has now made a multi-million-dollar investment. Dr. Alfred Hansel, Managing Director at Oncgnostics and responsible for international business development, stated, “Not every medical product receives approval for China. We’ve succeeded. Now the next step is expanding to whole Asia. Such success is only possible with strong partners.” One of these partners is now Grande Bio-tech Co. Ltd., with Mr. Hu Mu as Managing Director, who mentioned, “Oncgnostics is the right partner for us to take big steps in early cancer detection.”

bm-t and HTGF enable mega-deal

Mr. Michael Thiele, Senior Investment Manager at bm-t, Beteiligungsmanagement Thüringen GmbH, said: “Oncgnostics is a prime example of Thuringia-based companies operating at a global level. That’s why we are further expanding our commitment into Oncgnostics also with respect to pipeline product development.” Dr. Bernd Goergen, partner at HTGF, High-Tech Gründerfonds, stated, “As an investor from the very beginning, we know the potential of Oncgnostics’ technology. Therefore, we also participated in this financing round.”

The GynTect-Test

Gyntect is a swab test that accurately determines within a few hours whether there is a precancerous condition or a tumor on the cervix. “With this test we are able to make quick and reliable assessments of a potential cancer condition. The usual months-long uncertainty until follow-up examinations is eliminated,” said Dr. Martina Schmitz, CEO and Scientific Director of Oncgnostics. At the same time, if there is an elevated cancer risk or cancer diagnosis, treatment can be initiated more promptly. The test detects changes in the genetic material of cells and does not require invasive tissue sampling.

Oncgnostics GmbH, a biotech startup spin off from the Jena University Hospital, develops molecular biology tests for cancer diagnostics based on epigenetic changes in the human genome. With Gyntect, the company introduced an innovation in the field of cervical cancer screening. Currently, the startup is developing further tests for head and neck cancers. The team of researchers led by founders Dr. Alfred Hansel (CEO) and Dr. Martina Schmitz (CSO) received the Thuringia Innovation Prize twice (2014, 2017) for their diagnostic approach.

The team of oncgnostics

oncgnostics at Medica 2022:

  • Cervical cancer screening test conquers China

  • Establishing early detection of head and neck tumours

  • First study results for screening test for vulva and vaginal cancer

  • At the joint stand of medways e.V. in Hall 15, Stand K10

Jena / Düsseldorf, November 08, 2022 – oncgnostics GmbH will present its technology, products and current study results at the largest trade fair in the medical sector. The company is an expert in molecular cancer diagnostics. Life-saving early detection is possible with the cancer tests developed by oncgnostics, which are based on patented biomarks.

Cancer diagnostics through biotechnology

DNA methylations form the basis of oncgnostics’ work. Specific changes in the DNA methylation pattern occur when cancer develops or is already present. The tests from oncgnostics detect these changes.

Innovation in cervical cancer screening

GynTect is the company’s first product. Used in cervical cancer diagnostics, the test is already being marketed in several European countries. In August of this year, it was approved in China, where it is marketed under exclusive licence. It is the first methylation test for triage of HPV-positive cases on the Chinese market.

The methylation test in cervical cancer screening

A cervical smear, as it is also taken for thin-layer cytology or the HPV test, is sufficient for the procedure. The test is a decision-making aid on how best to proceed after an abnormal screening result. GynTect not only allows to detect whether a tumour is already present, but also detects cervical lesions that may develop into cervical cancer – years in advance. Thus, risk assessment is greatly facilitated: on the one hand, unnecessary, premature operations can be avoided, and on the other hand, the chance for early and thus promising therapeutic measures can be increased.

ScreenYu Gyn is a further development of GynTect. The diagnostic test, which was CE IVD-approved in May this year, uses only one methylated DNA region, whereas GynTect detects six methylated DNA regions (biomarkers). This makes it particularly well suited for automation. With a simplified and automated test version, countries and regions can be served in which cervical cancer screening has hardly taken place so far. Most new cases of cervical cancer and most deaths due to the disease occur in these countries.

Establish early detection for head and neck tumours

Head and neck tumours are among the five most common cancers worldwide. They often develop unnoticed for a long time because the symptoms are usually unspecific for those affected. So far, no early diagnosis has been established for this group of tumours. oncgnostics is developing a test to change this. In this test, DNA methylation markers identified in cancer tissue and validated by oncgnostics, are detected in the patient’s saliva. The test will initially be used in post-surgical follow-up, as tumour markers that already appear in the primary tumour are also detectable in re-emerging tumours.

Vulva and vaginal cancer: early detection also overdue

Early detection of vulvar and vaginal cancer is also difficult due to non-specific symptoms or no symptoms at all. Initial studies have confirmed that a methylation test with the same biomarkers as for cervical cancer may also be useful here. oncgnostics is continuing to work on diagnostics for the early detection of vulvar and vaginal cancer on this basis.

_____________________________________________

About oncgnostics GmbH:

Jena-based oncgnostics GmbH specialises in the early detection of cancer. Its tests detect changes that are characteristic of the DNA of cancer cells. The company, founded in 2012, launched GynTect in 2015. In the context of early cervical cancer detection, the test clarifies whether cervical cancer or precancerous lesions are already present. oncgnostics GmbH is also conducting research into screening tests for other types of cancer. Detailed information is available at www.oncgnostics.com/en.

 

 

Free image material: www.oncgnostics.com/en/downloads

 

Contact:

oncgnostics GmbH

Löbstedter Str. 41

07749 Jena

Germany

Phone: +493641/5548550

pr(at)oncgnostics.com

www.oncgnostics.com

GynTect receives approval in China

Jena, August 25, 2022 – The cervical cancer screening test GynTect is now available to physicians and patients in China, the world’s most populous country. The product is the first approved methylation test for triage of HPV-positive cases in China. GynTect was developed by oncgnostics GmbH and is already approved in Europe.

Since 2017, there has been a cooperation between oncgnostics GmbH and the Chinese partner GeneoDx, a subsidiary of the Sinopharm Group. The GynTect clarification test has now been approved by the Chinese National Medical Products Administration (NMPA). An important prerequisite for this approval was a large-scale, multi-year study involving approximately 10,000 participants. The highly successful performance of GynTect in this study could again be demonstrated.

“Our China partners have done a remarkable job with their elaborate study. The subsequent approval for the Chinese market is an important milestone for both our partner and our company. The starting signal for sales in China has thus been given,” states Dr. Alfred Hansel, Managing Director of oncgnostics GmbH.

How GynTect works

The molecular biological test GynTect developed by oncgnostics clarifies early on whether a patient with an abnormal finding after undergoing cervical cancer screening has a predisposition for or already has cervical carcinoma (cervical cancer), resulting in the need for prompt treatment.

This screening test detects epigenetic changes, so-called methylations. Merely a cervical smear, also obtained for thin-layer cytology or HPV testing, is needed to perform this test. GynTect has a high sensitivity rate – to this date all cancer cases have been detected in studies in which it is used. In addition, the test has a very high specificity rate: very few women with inconspicuous findings are GynTect-positive. This positive aspect has been reconfirmed by the Chinese approval study.

GeneoDx distributes GynTect in China under exclusive license

“We are pleased to announce that GeneoDx has received approval for GynTect, the first DNA methylation-based cervical cancer screening diagnostic in China. This is a huge milestone for GeneoDx, but also for all Chinese women now having access to such an innovative product!” said Xiaokai Xia, Managing Director of Shanghai GeneoDx.

China is home to more than 400 million women between the ages of 25 and 64, all of whom are at risk of developing cervical cancer. More than 100,000 new cancer cases and nearly 60,000 deaths are reported here annually. GynTect’s approval means it can now be used in women 30 years and older who are infected with high-risk, cancer-causing HPV types. Screening studies showed that approximately 17% of women in China are infected with one of these types of high-risk HPV. This equates to about 70 million female patients who need screening. However, only few women with a HPV infection actually develop cervical cancer. It is precisely these cases that the GynTect test is designed to detect.

Advantages of GynTect

GynTect provides fast and reliable test results, giving affected women the certainty they need in order to effectively proceed with needed care upon receiving an abnormal screening result. Risk assessment is greatly facilitated due to the avoidance of unnecessary premature surgery and the increased chances of determining successful therapeutic measures. According to GeneoDx, the number of colposcopy referrals can be reduced by more than 60% when using GynTect.

In addition to numerous EU countries and the People’s Republic of China, GynTect is already being marketed in Brazil and Mexico. The oncgnostics GmbH is continually working to establish further suitable distribution partnerships with other countries worldwide.

About oncgnostics GmbH:

The Jena-based company oncgnostics GmbH specializes in the early detection of cancer. Its tests detect changes characteristic of cancer cell DNA. Founded in 2012, the company launched the GynTect test for cervical cancer diagnostics in 2015. oncgnostics GmbH is also conducting research into other cancer-type screening tests. For detailed information, please visit our website www.oncgnostics.com.

About GeneoDx and the SINOPHARM Group

GeneoDx is a subsidiary of Sinopharm Group (China National Pharmaceutical Group Co Ltd.). As one of the country’s leading healthcare companies, Sinopharm has built a nationwide logistics and distribution network for pharmaceuticals, medical devices and equipment. Starting from research and development, manufacturing, distribution, technical and financial services, the Group covers the whole range of the industry.

 

 Contact:
oncgnostics GmbH
Löbstedter Str. 41
07749 Jena
Germany
Tel.: 03641/5548550

pr(at)oncgnostics.com
www.oncgnostics.com

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

team of oncgnostics celebrates 10th anniversary

The company oncgnostics GmbH, founded in 2012, already launched its first product in 2015: the diagnostic test for cervical cancer “GynTect”. This is now sold in over ten countries in Europe and Asia. In addition, oncgnostics conducts research in the field of diagnostics for head and neck cancer. The company is growing steadily and has around 20 employees, all of whom have remained loyal to the company to date.

 

The success story of oncgnostics GmbH began in February 2012. “We realized that we wanted to use our research results obtained at the University Women’s Hospital Jena beyond science. Cervical cancer screening was in urgent need of improvement – and we had a solution,” CEO Dr. Alfred Hansel describes the original idea. Thus, a small team around CEO Dr. Martina Schmitz and Dr. Alfred Hansel spun off from the Gynecological Molecular Biology Department of the University Hospital Jena (UKJ).

Detecting cancer with the help of biomarkers

Core expertise of the company are molecular biology markers that can be used to reliably detect cancer cells. These markers are bundled for specific tests. For example, in the case of abnormal gynecological findings, the GynTect test clarifies whether cervical cancer is developing or whether the abnormalities will heal on their own.

The company is also conducting research into the early detection of head and neck tumors. Unlike cervical cancer screening, there is still no regulated procedure for this disease. The Jena-based company is involved in the development of a test designed to detect cancers of the mouth and throat.

Oncgnostics’ overall goal is to improve cancer screening and prevent unnecessary cases. “Cervical cancer shouldn’t even exist anymore with today’s diagnostic and screening options,” said Dr. Martina Schmitz, CSO.

Important support from science and investors

“Without our investors and partners, we would not be where we are today. That is why we would like to express our thanks to everyone who has supported us over the past ten years,” adds Dr. Martina Schmitz. The company continues to be supported by the University Hospital Jena, other partners from the scientific community, and investors. Private investors as well as retail investors have also invested in the company in two very successful crowdinvesting campaigns.

A large proportion of women who develop cervical cancer in high-income countries such as Germany do not regularly attend screening. This is particularly alarming, as cancer screenings have become much less frequent since the onset of the corona pandemic. A study by Hannover Medical School and the biotechnology company oncgnostics GmbH is testing self-tests as a possible solution to reach more people. Cervical cancer also has the best chance of recovery if detected early. The study results show that specific screening tests can be performed at home in the future.

Procedure of the pilot study

For the study, 87 patients at the colposcopy clinic of Hannover each took a smear test on themselves. A gynecological specialist then took another smear. In the first step, the samples were tested for HPV infections present. The GynTect cervical cancer test from oncgnostics was then used for all samples. This determines whether the existing HPV infection heals on its own or can develop into cancer. No further smear test is necessary for this. The test is carried out in the laboratory with the sample at hand.

In 95.5 percent of the self-smears, the result of the HPV tests matched those of the samples taken by the doctors. This is seen as a good sign that women could self-sample for this test in the future. For the GynTect test, the agreement between self-tests and physician samples was lower.

Detection with independently taken samples can work

“GynTect works by using specific biomarkers. It examines the DNA of cells in a smear and raises the alarm if there are  changes typical of cancer. The study suggests that precancerous lesions as well as cancer can be detected well even with samples taken independently. Of course, the method needs to be further optimised to increase the hit rate. We are also currently working on the detection of the markers in urine samples. We are obtaining promising initial results. In addition, urine samples are much easier for the patient to take than swabs,” explains Martina Schmitz, Managing Director of oncgnostics GmbH and co-author of the study.

For further research and development on the self-tests, the Jena-based biotechnology company continues to cooperate with the Hannover Medical School and two research institutions in the Netherlands and Belgium.

Large-scale study “HaSCo”

Based on the promising results of this feasibility study, GynTect will be used as a clarification test for HPV-positive self-tests in the large-scale HaSCo study of the Hanover Medical School, which will start later this year and include >20,000 subjects.

Almost every adult becomes infected with HPV at some point in their lives without realising it. It is estimated that six million women in Germany become infected with HPV each year. Each year, several hundred thousand of them are diagnosed with abnormalities, some of which could develop into cervical cancer. About 4,300 develop cancer, which in turn kills about 1,600 affected individuals.

 

Picture: MIA Studio / Shutterstock.com

The biotechnology company oncgnostics GmbH is researching a method for diagnosing Head-and-Neck tumors together with the clinical department for general ENT at the Medical University of Graz as part of the “OroCa-Graz” study. 550,000 people worldwide develop carcinomas of this type every year. As only advanced stages of tumours are often diagnosed, more than 300,000 of those affected die each year. The study aims to demonstrate that the diagnostic method developed for Head-and-Neck tumors and especially mouth and throat cancer (= oropharyngeal cancer) can reliably and early detect malignant tumors using non-invasive saliva samples.

Excessive alcohol and tobacco consumption are among the main risk factors for Head-and-Neck cancer. In addition, there has been an increase in cases of carcinoma in the mouth and throat area in recent years, in which infection with the human papillomavirus (HPV) was found. The rate of these HPV-associated cancers increases by 2.1 percent annually. Non-HPV-associated Head-and-Neck cancers decreased slightly by 0.4 percent over the same period[1]. In Germany, a current proportion of 40 percent of HPV-induced diseases is assumed, and the trend is rising[2].

The “OroCa-Graz” study is led by Prof. Dr. Dietmar Thurnher, Head of the General ENT Department at the Medical University of Graz. He explains: “Despite increasing cases, the treatment of Head-and-Neck cancer has not made any significant progress in the last 20 years. Beside new diseases, half of the patients return as so-called tumor recurrence within the two years after completing therapy. Furthermore, no early diagnosis has yet been established for Head-and-Neck tumors. Our goal is to change that. By examining the relationship between oropharyngeal carcinomas, HPV infections and DNA methylation markers, new ways of early diagnosis as well as secondary and tertiary prevention are emerging.”

Secondary prevention is aimed at people with an increased risk of disease, for example smokers. With preventive examinations, clarification as well as screening tests, malignant diseases, especially in risk groups, could be diagnosed at an early stage or abnormalities could be clarified. Until now, the throat is inspected when symptoms arise. Tertiary prevention measures are aimed at tumor patients who are in regular clinical follow-up after treatment.

“OroCa-Graz”: Course of study

As part of the “OroCa-Graz” study, tissue and saliva samples from patients with oropharyngeal cancer are examined comparatively. By submitting a simple saliva sample, complaints in the head and neck area should be clarified later. The detection of a malignant disease is carried out via the detection of tumor-specific DNA methylation markers, which were developed by oncgnostics. The HPV status of all samples is also determined. Based on these results, the scientists analyse how sensitive the tumor detection by the methylation markers is and whether there is a connection between the occurrence of the tumor markers and an HPV infection.

Additional saliva samples are taken during follow-up. The idea is that tumor markers that have already been detected in the primary tumor return in the development of recurrences. If the tumor markers are detected in the follow-up, action can be taken at an early stage.

Research on DNA methylation markers since 2012

Since its foundation in 2012, oncgnostics GmbH has been specifically engaged in the search for DNA methylation markers, including Head-and-neck tumors. So far, a set of potential tumor markers based on tissue and swab samples has been established for the disease. One of these tumor markers is already used in the diagnosis of cervical cancer in the GynTect® test.

“Changes in the DNA methylation pattern occur early in tumor development. By detecting our cancer-specific biomarkers, we can check, for example, if cancer precursors are present. In the future, the application could be a powerful tool for early detection in the context of cancer screening and as part of the follow-up examinations for oropharyngeal carcinomas,” said Dr. Martina Schmitz, CEO of oncgnostics GmbH.

[1] Universität Leipzig (2020): Oropharynxkarzinom: Gute Prognose – aber nicht für alle Patienten. Online available: https://www.quintessence-publishing.com/deu/de/news/nachrichten/bunte-welt/oropharynxkarzinom-gute-prognose-aber-nicht-fuer-alle-patienten

[2] Wagner S. et al. (2018): Das HPV-getriebene Oropharynxkarzinom – Inzidenz, Trends, Diagnose und Therapie. In: Der Urologe 57:1457–1463. Online available: https://pubmed.ncbi.nlm.nih.gov/28713770/

Biotechnology company oncgnostics GmbH is announcing a collaboration with the international diagnostics group EUROIMMUN, a PerkinElmer company. As part of the cooperation, EUROIMMUN will sell the cervical cancer test from oncgnostics GmbH, Gyn-Tect, in the European countries of Portugal, Italy, Turkey and Poland. Also the test is expected to be approved and on sale in Canada by the end of 2021.

The partnership is a valuable addition to the product portfolios of both companies: For seven years, EUROIMMUN has been successfully selling the EUROArray HPV, a molecular genetic test for the detection and complete genotyping of human papilloma viruses (HPV). The EUROIMMUN test can detect an HPV infection in women with a very high degree of certainty. However, not every HPV infection leads to a serious illness as most women with an HPV infection remain healthy and the infection heals on its own. Yet, no HPV test can predict this development. At this point the GynTect test developed by oncgnostics GmbH comes in. The innovation of this test enables the reliable detection of DNA methylations, which are only present in the development of cancer cells. Thus, a malignant change that can develop into cancer can be detected by this solution.

“With the addition of GynTect to our product range, EUROIMMUN now has a complete package for cervical cancer diagnostics,” said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “The EUROArray HPV helps to estimate the individual cancer risk of patients thanks to the clear identification of 30 HPV subtypes. With GynTect, this risk can now be further specified with an additional step. A negative GynTect test can give many women with a proven HPV infection a sign of relief at an early stage.”

Oncgnostics produces GynTect tests in its own production laboratory in Germany. They are sold internationally through EUROIMMUN to laboratories that carry out and evaluate the tests locally in the various countries.

Additional international cooperations

Beside the first four EU countries and Canada, GynTect will be gradually introduced into other EU markets. “We consider the fight against cervical cancer as a global challenge. In addition to the nationwide vaccination, precise preventive tests play a major role. We are very pleased that this partnership gives us access to the widely developed EUROIMMUN sales network. By making new contacts with laboratories and physicians, more and more women are benefiting from the advantages of GynTect. We are building on this and are looking forward to working together,” says Dr. Martina Schmitz, managing director of oncgnostics GmbH.

 

GynTect is a molecular biological test that detects six areas of the human genome that are only methylated when cancer cells develop. Thus, GynTect recognises malignant changes in patients.

 

About EUROIMMUN Medizinische Labordiagnostika AG:

As one of the world’s leading manufacturers in the field of medical laboratory diagnostics, EUROIMMUN stands for innovation. More than 3,200 employees in 17 countries develop, produce and distribute test systems that can be used for diagnosing diseases, as well as software and automation solutions for applying and evaluating the tests. Laboratories in over 150 countries use EUROIMMUN products to diagnose autoimmune and infectious diseases as well as allergies and to carry out gene analyses. EUROIMMUN has been part of the US company PerkinElmer Inc. since 2018.

For more information, see www.euroimmun.de/en/