Jena, Thuringia, March 31, 2025. Jena-based Oncgnostics GmbH has filed for insolvency. The Gera District Court has ordered and appointed lawyer Kai Dellit from the law firm hww hermann wienberg wilhelm as the provisional insolvency administrator. All business operations will continue after the insolvency filing.

The products of oncgnostics GmbH enable the early and precise detection of gynecological cancers, such as cervical cancer. Unlike conventional methods, which usually rely on visual recognition of altered cells or the detection of Human Papillomavirus (HPV), oncgnostics’ molecular biological tests examine the DNA of cervical cells for cancer-specific changes. These types of test also help to determine whether cell changes will rather heal or develop into cancer. Affected women can therefore gain valuable time for successful treatment.

Oncgnostics GmbH has been researching cancer diagnostics for over 13 years with a team of 20 employees. Since 2015, the company’s diagnostics tests have been internationally approved, they are currently being sold in Europe and Asia.

Developing diagnostic tests requires significant time and money, according to the managing directors Dr. Schmitz and Dr. Hansel. “We were actually well-positioned to raise additional funds, due to financing commitments of our shareholders. However, due to delayed issuance of funds promised by a shareholder from Hong Kong, we got in financial difficulties, which now made filing for bankruptcy inevitable,” the managing directors further explain.

The company will be restructured as part of the insolvency proceedings. However, its future is likely only secured with an investor. “With the support of Rödl Corporate Finance GmbH, we have already started looking for investors for oncgnostics,” says the restructuring expert and provisional insolvency administrator Dellit.

“We will do everything necessary to continue offering our innovative and life-saving products to patients in Europe,” the managing directors conclude.

About oncgnostics GmbH

oncgnostics GmbH focuses on the development and marketing of in vitro diagnostic tests, specifically for gynecological cancers like cervical cancer, based on epigenetic markers for early cancer detection and follow-up care. Currently, the company markets two DNA methylation-based diagnostic kits. GynTect detects methylated DNA regions in cervical smears to identify cancer or its precursors, and ScreenYu Gyn uses only a single epigenetic marker but offers the same reliability as an alternative test, enabling a simplified evaluation process. Oncgnostics GmbH is also currently developing diagnostic tests for head and neck cancers.

About hww hermann wienberg wilhelm

hww hermann wienberg wilhelm is a service provider specializing in legal advice, restructuring, bankruptcy, and compulsory administration. With several hundred employees, hww operates at more than 20 locations across Germany and has its own international network. The lawyers at hww hermann wienberg wilhelm have been appointed in thousands of insolvency proceedings by numerous insolvency courts throughout their long-standing practice. Notable cases handled by the firm include the insolvencies of Holzmann, Karmann, DWW Woolworth, Q-Cells SE, Germania, Thomas Cook, and the automotive supplier Minda.

About the provisional insolvency administrator, Attorney Kai Dellit

Kai Dellit, lawyer and partner at hww hermann wienberg wilhelm, is a restructuring expert and has been responsible for the successful restructuring of several companies including the healthcare company Vidi GmbH, detergent manufacturer domal-wittol Wasch- und Reinigungsmittel GmbH, the producer of consumables Altenburger Destillerie & Liqeurfabrik GmbH, construction company Sauerbrey Bau- und Vertriebs GmbH, porcelain manufacturer Kahla/Thüringen Porzellan GmbH, hospital operator AccuMeda Health Invest GmbH, nursing home operators Seniorenresidenz am Türmchen GmbH and Seniorenzentrum Wolfhagen gGmbH , online retailer Samenhaus Müller GmbH, as well as automotive suppliers Bo Parts GmbH, Präzisionstechnik Reichenbach GmbH, Ibex Automotive GmbH (Kunze Group), and MKB Metall-Konstruktions- und Betriebsmittelbau GmbH & Co. KG. www.hww.eu/ueber-uns/mitarbeiter/details/kai-dellit/

Press Contact Person:
hww hermann wienberg wilhelm
Frau Rechtsanwältin Janette Wild
Tel.: 0361 601314-0
E-Mail: dellit@hww.eu

Jena / Düsseldorf, November 7, 2024 – Molecular biological diagnostics offer a non-invasive alternative for cancer detection. oncgnostics GmbH will demonstrate this in Düsseldorf at MEDICA, one of the world’s largest medical trade fairs. The biotechnology company develops patented, highly informative biomarkers for their methylation tests, which are currently used in cervical cancer screening. In the future, these tests should also enable the diagnosis of head and neck tumors from liquid biopsies.

• Cervical cancer diagnostics: the GynTect and ScreenYu Gyn methylation tests from oncgnostics GmbH
• Methylation testing in cervical cancer screening could help prevent up to 75% of colposcopies: this is the result of a study which utilized the oncgnostics cervical cancer test
• Diagnosis of head and neck tumors from liquid biopsies: development of a methylation test that non-invasively detects tumor recurrence
• oncgnostics GmbH will be at MEDICA at the joint stand of medways e.V. in Hall 3/ G74

Tests for cervical cancer

The GynTect methylation test is used in cervical cancer diagnostics. The test is marketed in several European countries and is also under exclusive license in China. In China, it is the first DNA methylation test for the triage of HPV-positive cases. In Germany and Europe, GynTect helps clarify screening abnormalities thanks to its fast and reliable results.

ScreenYu Gyn is a development of GynTect. While Gyntect detects six methylated marker regions, ScreenYu Gyn only detects one. This makes ScreenYu Gyn suitable for automation and could enable new applications.

Methylation tests can replace invasive diagnostic methods

A study led by Dr. Pedro Vieira Baptista, President Elect of the International Society for the Study of Vulvovaginal Disease (IVVD), found that using the oncgnostics test GynTect in cervical cancer screening could prevent up to 75% of colposcopies.

Detection of head and neck tumors in liquid biopsies

The detection of tumor recurrence is still a challenge in everyday clinical practice due to a lack of quick and simple diagnostics. The development of a methylation test based on liquid biopsies (saliva and mouth swabs) could close this gap. Thanks to an international network of study centers, oncgnostics GmbH has extensive data at its disposal to test the suitability of epigenetic tumor markers for the detection of head and neck tumors.

 About oncgnostics:

The biotechnology company oncgnostics GmbH, a spin-off from the Jena University Hospital, develops molecular biological tests for cancer diagnostics based on epigenetic changes in genetic material. With GynTect, the company has introduced an innovation in the field of cervical cancer screening. oncgnostics is currently developing other tests for head and neck cancers.

Free image material: www.oncgnostics.com/downloads

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.

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.

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