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.

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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

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

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/

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

 

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

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.

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.

Jena, 20. February, 2019 – The test for early detection of cervical cancer GynTect® may now also be performed on the cobas Z480 analyzer, a widely used quantitative PCR (QPCR) system from Roche Diagnostics. This is now possible through an extension of the GynTect® CE IVD mark (CE mark for in vitro diagnostics). The biotech company oncgnostics GmbH is developer and provider of GynTect®.

GynTect® allows a fast and reliable clarification, if a patient with abnormal Pap smear findings or an HPV infection, is about to develop or already has cervical cancer. GynTect® allows to detect modified, esp. methylated DNA regions. Methylation of these DNA regions specifically occurs in cervical cancer.

Performance of GynTect using the Cobas Z480
Two steps are required for the performance of GynTect®. In the first step a chemical treatment with bisulphite fixates the DNA methylation of the diagnostic material. For the detection of the marker regions a PCR (Polymerase Chain Reaction) is required. The cobas Z480 Analyzer by Roche Diagnostics allows the performance of such a diagnostic PCR. Based on the data obtained in the PCR, the GynTect® results are derived. Only originally methylated DNA regions present in the sample are amplified during the PCR. This procedure is termed methylation-specific PCR (MSP).

More laboratories may perform GynTect® now
“By now GynTect® could only be performed on the ABI7500 Real-Time PCR system from Life Technologies. Extension of the CE IVD mark now allows to run the test on the cobas Z480 PCR system as well. With its widespread availability many more laboratories now can perform GynTect® without any additional expenses”, Alfred Hansel, co-founder and CEO of oncgnostics said.

You may find free press material here:
www.oncgnostics.com/downloads
vimeo.com/243256803

Oncgnostics will discuss new clinical data with gynaecological key opinion leaders at EUROGIN 2018

SAN FRANCISCO, CA, USA, November 29, 2018 — Oncgnostics GmbH presents new clinical data on GynTect® Precision Diagnostics for triage of unclear cervical cancer screening tests.

Oncgnostics GmbH, a Jena/Germany based company, has developed GynTect® for precision detection of cervical cancer. GynTect® was tested and validated in clinical trials on more than 3,000 samples with a remarkable detection score of 100% in all cervical cancer cases. Moreover, GynTect® identifies all relevant pre-cancerous lesions due to its first-of-a-kind prognostic value.

“We have concluded further clinical trials on the performance of GynTect® in comparison to alternative cervical cancer triage approaches. These results are very convincing and we are happy to present them in 5 talks at the EUROGIN 2018 conference in Lisbon next week”, states Dr. Alfred Hansel, Oncgnostics Chief Executive Officer.

Together with CSO Dr. Martina Schmitz and three Oncgnostics R&D specialists for cervical cancer and head-and-neck cancer diagnostics, Oncgnostics will discuss the new clinical data with gynecological key opinion leaders at Oncgnostics booth for precision cancer diagnostics.

Oncgnostics technology has been exclusively licensed out in 2017 to Sinopharm Group for the greater China region.

Biotech Alliances International Inc., a Silicon Valley-based healthcare-focused investment bank, is serving as the lead investment banker to Oncgnostics globalization and partnering strategy. Meetings with Oncgnostics Management Team can be coordinated at EUROGIN 2018 or JPM2019.

 

About Oncgnostics GmbH

Oncgnostics GmbH, founded in early 2012 as a spin-off from the Jena University women’s hospital, is a molecular diagnostics company specializing in cancer diagnostics. Oncgnostics tests target epigenetic changes, so-called DNA methylations, that typically occur in cancer cells. The patented biomarkers, which are evaluated using a specific algorithm, are the core of the products and provide the basis for the company’s activities.

About Biotech Alliances International Inc.

Biotech Alliances International Inc. is a San Francisco-based investment bank serving life sciences companies, private equity, and venture capital funds. It provides independent financial and strategic advice including corporate finance, mergers & acquisitions, partnering & licensing, and strategic consulting.

Dr. Franck Brinkhaus
Biotech Alliances International Inc
+1 650-868-8511