Cancer diagnostics of the future thanks to highly informative biomarkers

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.

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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

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German oncgnostics GmbH‘s innovation in the area of cervical cancer diagnostics now also available in China

Proudktfoto - zwei Karton von GynTect gestapelt Foto: GenoDxGeneoDx

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

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PCR test detects cervical precancerous lesions

,
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 oncgnostics. It 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.

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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

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Cancer prevention remains a matter of the heart: Biotech company oncgnostics celebrates 10th anniversary

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.

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Pilot study: Cancer screening from home is possible

"HPV-Vorsorge durch Selbsttests in die eigene Hand nehmen" - Auf dem Bild sind Hände zu sehen, in denen die Buchstaben für HPV liegen.shutterstock.com 1936727821

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

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International sales partnership with EUROIMMUN for Distribution of GynTect

Vertriebspartnerschaft zwischen der oncgnostics GmbH und der EUROIMMUN Medizinische Labordiagnostika AGoncgnostics GmbH Susann Nuernberger / EUROIMMUN Medizinische Labordiagnostika AG

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.

Mehr Informationen

 

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/

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On the World Mental Health Day

Post-traumatic stress oncgnostics GmbHoncgnostics GmbH

Abnormal results in Cervical Cancer Screening may trigger symptoms of post-traumatic stress disorder. Oncgnostics GmbH draws attention to this on the annual World Mental Health Day on 10 October and points out that conspicuous Pap test results and/or positive HPV tests have a negative effect on the psyche of the women concerned. The company, which specialises in the diagnosis of cancers, refers to a recent study.

In the study, 3,753 women were surveyed online. Out of these women, at least one abnormal finding was reported by about half of them as part of cervical cancer screenings. More than half of the affected women suffered from recurring abnormalities for more than a year. Stress over this long period of time has an impact on their mental health. 28 percent of the women showed symptoms of post-traumatic stress disorder at the time of the survey.

World Mental Health Day draws attention

Already in 1992, the World Mental Health Day was organised by the World Federation for Mental Health (WFMH). It aims at raising awareness of mental health and the needs of people with mental disorders. Physical illnesses are generally acknowledged by society and attributed to external causes. However, mental illnesses are still widely thought to be self-inflicted today.

oncgnostics GmbH draws attention to psychological distress

With the study published in July, oncgnostics’ managing directors Dr Alfred Hansel and Dr Martina Schmitz as co-authors point out the current situation in cervical cancer screening, as explained in detail in the press release below.

 

Press Release
On the World Mental Health Day
oncgnostics GmbH
10.10.2020

Download Press Release

 

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Cancer screening: Suddenly, it has an effect on family planning

Familienplanung: Wenn die Angst vor Krebs dazwischen funktAfrica Studio/Shutterstock.com

Experience reports from women who are in family planning, but for whom a conspicuous finding was made during cancer screening, are often characterised by uncertainty and frustration. After a joint appeal with anti-cancer activist Myriam von M., many women told us their stories. Some of them experienced high-risk pregnancies or even miscarriages after a conisation. They felt guilty and were afraid of a new pregnancy, despite their desire to have children.

Conspicuous finding: Effects on family planning

If there are abnormalities in cervical cancer screening, such as a conspicuous Pap finding or a positive HPV test, this can lead to psychological stress. This is shown by a new study for which 3,753 German women were surveyed.

  • According to this study, almost every second woman is psychologically stressed by the risks of conisation.
  • For almost a third of the respondents, the consideration of having a conisation has a strong influence on having a child.

These women’s insecurity is partly the result of the so-called “watchful waiting”. Any abnormalities found in the tissue often heal on their own. Therefore, they are often observed with repeated tests over a long period of time. Women who have not yet completed family planning might have the feeling as if they are losing valuable time. The knowledge that cervical cancer will develop over many years can also put women who wish to have children under time pressure. These women might want to become pregnant as quickly as possible before the supposedly bad results of the cervical smear worsen.

Is there a connection between conisation and preterm birth?

If the results of the examination remain conspicuous or if the findings deteriorate, the probability of cancer increases. In this case, the doctor is allowed to recommend and perform a conisation. The cervix is cut out in the shape of a cone [1].

It is controversial whether there is a direct connection between such an intervention and a premature birth. However, various scientific studies suggest that the risk of preterm birth increases after a conisation has been performed.

Study results from 2010 [2] showed:

  • Every third woman who underwent two conisations had a preterm birth before the 37th week of pregnancy. Among the women with one conisation, this happened to eleven percent, without a conisation four percent were concerned.
  • Extreme premature births before the 28th week of pregnancy occurred for three percent of women who had two conisations. It was one percent among the women with one conisation and 0.3 percent among those without surgery.

It becomes understandable that women who are affected are worried about planning a first or further pregnancy.

Signs of cervical cancer: Pregnancy is not impossible

Important Note: Abnormalities in cervical cancer screening are not an obstacle to the family planning for women. It is necessary to interpret the signs precisely. The human papillomavirus (HPV) infection can cause cancer, but it does not have to. The majority of women have had an HPV infection in their lives that usually heals on its own completely unnoticed. Conspicuous Pap finding might worsen, but it can also improve. Rarely does cancer actually develop out of it.

Cervical cancer develops through various preliminary stages. It can be diagnosed at an early stage. In this case, the cancer is almost always curable. The uterus itself is preserved and is not damaged.

It becomes clear that regular preventive examinations at the gynecologist are an important part of family planning even before the actual pregnancy. In case of abnormal Pap smear results or HPV infections, molecular biological methods can help to find out whether these abnormalities are actually a sign of a pre-cancerous stage or an already existing cancer. The time of the close examinations at the gynecologist can thus be significantly shortened and decisions to preserve the women’s healthcare can be made very soon. Therefore, surgical interventions such as a conisation can also be avoided.

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[1] https://www.krebsgesellschaft.de/onko-internetportal/basis-informationen-krebs/leben-mit-krebs/kinderwunsch-und-krebs/erhalt-der-fruchtbarkeit.html

[2] Ørtoft et al. (2010): After conisation of the cervix, the perinatal mortality as a result of preterm delivery increases in subsequent pregnancy, in: BJOG 117:258–267.

 

Photo: Africa Studio/Shutterstock.com

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Sepsis: In which Patients does the Immune System Break Down?

Sepsis: Symptomeoncgnostics GmbH

As part of a new EU consortium, Oncgnostics GmbH is investigating diagnostic possibilities of immune collapse after sepsis.

More than 140 people die every day in Germany of sepsis, commonly known as blood poisoning. Two thirds of them do not die from the out of control inflammatory reactions in the whole body, but rather from the consequences of a subsequent weakened immune system. Scientists from Germany, Belgium and Austria now want to investigate which patients are at risk, and how the dangerous breakdown of the immune system can be diagnosed as early as possible, in the joint project SEPSDIA (Development of an epigenetics-based blood test to detect immunosuppression in patients with sepsis). The aim is to identify markers in the blood of patients which can be used for an early test. As a specialist for epigenetic biomarkers, oncgnostics GmbH is providing scientific support for the project and carrying out analyses.

The Belgian company Diagenode, which is in charge of the joint project, is responsible for the development of the test kit, Platomics GmbH from Austria provides the software for the evaluation of the test results, and a research group from the Hospital of Anaesthesiology, Heidelberg University Hospital, is investigating the molecular mechanisms of sepsis.

Sepsis develops as a consequence of an infection, such as pneumonia, infected injuries or as a complication after major surgery. It starts from the site of infection, then the immune reaction spreads and the organism goes into a state of shock, resulting in organ failure. Yet thanks to modern treatment concepts in intensive medical care, this highly life-threatening condition is no longer the main cause of death for sepsis today. As dramatic as the initial over- and malfunctioning of the immune system can be, the subsequent phase in which the immune system collapses is no less dangerous, even if more silent. In these patients, new infections with pathogens, occur all the time, which are very typical of a weakened immune system.  Patients often need intensive medical care for weeks or months, and sometimes antibiotic therapies fail.

‘Core of our business is the detection of characteristic changes in cancer cells using epigenetic markers, and we are now applying this expertise to a new medical field. This is what makes it attractive for us to actively participate in this project, by identifying and characterising DNA methylation markers in Sepsis,’ oncgnostics Managing Director Dr Martina Schmitz explains.

About oncgnostics GmbH:

Oncgnostics GmbH, based in Jena, specialises in the early detection of cancer. Its tests detect changes that are characteristic of the DNA of cancer cells. Founded in 2012, the company launched GynTect in 2015. As part of early detection of cervical cancer, the test clarifies whether cervical cancer or precursors thereof are already present. Oncgnostics GmbH also conducts research with the goal to develop tests for other types of cancer. Detailed information is available at www.oncgnostics.com.

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Oncgnostics Expands Business Relations in Asia

The oncgnostics managers together with Geneo Dx managers and colleagues.

Approval for cervical cancer screening test in the Chinese market expected in early 2020 / First contacts in Japan

Shanghai/Yokohama/Tokyo/Jena, 1 November 2019 –Our business partner in China, GeneoDx, is about to get approval to commercialise GynTect in the Chinese market. This issue was discussed at a business meeting with representatives from oncgnostics GmbH in Shanghai.

Our Chinese business partner GeneoDx, a SINOPHARM subsidiary, presented oncgnostics’ managing directors, Dr Martina Schmitz and Dr Alfred Hansel, in Shanghai with the results of their recently completed approval study for the National Medical Products Administration (NMPA) for the molecular biological test GynTect. The approval of GynTect for the Chinese market is expected in early 2020. The test allows reliable and rapid diagnosis of cervical cancer and its precancerous stages.

‘Our partners have conducted a study with approximately 1,300 samples. Results look very promising. We are optimistic that GeneoDx will receive approval for GynTect without any problems. Moreover, the study will be followed by high-ranking publications,’ states oncgnostics’ managing director Martina Schmitz.

Dr Alfred Hansel visited BioJapan in Yokohama, Japan. At the conference, he cultivated existing contacts, which he had made during a visit to MedTech Japan in Tokyo earlier this year. He also held discussions with other companies on the marketing opportunities of GynTect in Japan and other countries in Southeast Asia.

The Asian market is interesting for oncgnostics not only with regard to GynTect. International partnerships are also being sought for current pipeline projects, in particular the development of assays in the field of head and neck tumour diagnostics.

About oncgnostics:

Jena’s oncgnostics GmbH specialises in the early detection of cancer. Its tests detect changes that are characteristic of cancer cells’ DNA. Founded in 2012, the company launched GynTect in 2015. As part of its programme for the early detection of cervical cancer, the test clarifies whether cervical cancer or precancerous lesions are already present. In April 2017, GeneoDx and oncgnostics signed an exclusive license agreement for GynTect in China, Hong Kong, and Macau.

Oncgnostics GmbH is also conducting research into tests for the clarification of other types of cancer. Detailed information is available at www.oncgnostics.com.

About GynTect:

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

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