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

Jena, October 17, 2018 – The Thuringian molecular diagnostics company oncgnostics, which quickly and successfully closed a 750,000 Euros crowd-investing round on Seedmatch early in 2018, now announces the closing of another similarly sized round. oncgnostics has developed the cervical cancer diagnostics test GynTect®, and a private investor circle now invests together with the  current institutional investor beteiligungsmanagement thüringen (bm-t). The company will use the total investment for performing further clinical trials and for intensifying its international marketing efforts.

 

At the end of 2017, oncgnostics started a second campaign for its diagnostic test GynTect via the crowd-investing platform Seedmatch. It took only 2.5 hours until the funding reached the threshold of 100,000 EUR, and only three weeks to reach a total sum of 750,000EUR, making : it the fastest crowd-investing campaign for a life sciences company in Germany. Now this sum will be doubled by beteiligungsmanagement thüringen (bm-t), which is already a key shareholder at oncgnostics, and by a circle of private investors.

 

“oncgnostics´ GynTect test addresses a potential billion-dollar market. This investment will allow the company to build targeted sales and marketing efforts in order to better access and develop this attractive market. Additionally, the company has a compelling technology pipeline, which will be further advanced with this capital. We´re very pleased to join this investment round“, Kevin Reeder, CEO at bm-t, stated.

 

Better options for early diagnosis

GynTect clarifies early and reliably, if a patient is about to develop or even already has developed a cervical lesion that may advance to cancer. This improves the risk assessment for cervical cancer screening: on the one hand, unnecessary and overly-hasty surgeries can be avoided. On the other hand, the chance for early and successful treatment is improved. Patients also lose their anxiety about unclear results based on the current screening and instead gain fast certainty.

 

“We are very pleased that our concept of using epigenetic markers in cancer diagnostics together with the market potential of our first test GynTect convinced new investors to join oncgnostics. Their investment enables us to improve our market opportunities not only through enhanced international marketing, but also through further product developments”, Dr. Alfred Hansel, CEO of oncgnostics, says.

 

Past and future developments

The first steps for international marketing were made with an exclusive out-licensing of GynTect to a Chinese partner for the Chinese market as well as with first contracts for distributing the test in selected European countries (Portugal, Slovakia and the Czech Republic). Further strategic and distribution partnerships are now sought, especially for the US market, but also for additional European markets. In December 2017, the first patients were enrolled in a prospective clinical trial, with a three-year duration and across ten gynaecological practices and clinical centers, with the aim of further demonstrating the prognostic power of GynTect . Another trial investigating the psychological burden of women with abnormal Pap smear and/or positive HPV test results was recently completed, and its results are scheduled to be published by the end of this year.

 

Together with clinical partners, oncgnostics is developing diagnostic tests for other cancers. The Thuringian company is currently validating epigenetic markers for use in head and neck cancer, and it is also targeting tests that will help to improve timely detection of ovarian cancer.

 

About oncgnostics GmbH:

oncgnostics GmbH was founded in 2012 from a university research group at the Jena University Gynaecology Department. As a molecular diagnostics firm, the Jena start-up has specialised in the early diagnosis of cancer. The company´s tests demonstrate characteristic epigenetic changes in cancer cells, known as DNA methylations. The patented biomarkers identified with specific algorithms form the central core of the products and are the foundation of the firm´s technological assets.

 

 

Free pictorial materials for dissemination may be found at: https://www.oncgnostics.com/downloads

https://tinyurl.com/oncgnostics

https://vimeo.com/243256803

Logo Biotech Alliances International

2018-10-02 San Francisco/Jena, Germany:

Biotech Alliances International Inc., a Silicon Valley-based healthcare-focused investment bank, announced today that it will serve as the lead investment banker to Oncgnostics globalisation and partnering strategy.

Early detection of cervical cancer is critical for patient’s health and survival.  Current diagnostic methods are inefficient and fail to detect 50% of the cases of cervical cancer. Failure in precision detection of cervical carcinoma leads to unsuccessful as well as unnecessary treatments. Therefore cervical cancer still is a significant problem for patients and health care systems.

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.

“Our product GynTect® can eliminate unsuccessful as well as unnecessary treatments in the current screening systems. Poor diagnostics leads to unnecessarily long and intensive patient management resulting in medical complications, psychological burden and high costs“, said Dr. Alfred Hansel, Oncgnostics Chief Executive Officer. By overcoming these shortcomings, GynTect® generates significant economic benefits for national health systems, savings e.g. for German healthcare system are estimated at $300m p.a.

“We are very impressed with Oncgnostics precision diagnostics which can provide superior outcomes for patients by avoiding unnecessary surgery as well as increasing patients survival rates” said Dr. Franck Brinkhaus, CEO of Biotech Alliances International: „We are very proud to welcome Oncgnostics to our growing group of European clients and are looking forward to working with the entire Oncgnostics team on this assignment.“

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

 

 

About oncgnostics

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

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, deal sourcing and strategic consulting.

Contact:

Dr. Franck Brinkhaus
Biotech Alliances International Inc.
(1) 650 868 8511
email us here

 

Portugal Partnership

Lisbon/Jena, April 16th 2018 – Speculum S.A. is the exclusive licence partner of oncgnostics GmbH for the screening test GynTect® in Portugal. The test is designed to further specify abnormal results in screening examinations and to help determine the best treatment approach.

 

In January, the biotech firm oncgnostics GmbH from Jena (Germany), concluded an exclusive sales partnership for the GynTect screening test in Slovakia and the Czech Republic. Now, Speculum S.A. in Portugal has become the newest sales partner to obtain an exclusive licence. As a result, Portugal becomes the fourth European country where GynTect will be offered.

 

Speculum S.A. is well positioned in Portugal

The Team of Speculum S.A. in Portugal

The Team of Speculum S.A. in Portugal. Source: Speculum S.A.

 

 

 

 

 

Speculum S.A. sells a range of medical devices focused on gynaecology. The firm is very extensively networked with professionals and leading figures in the area of women’s health. In addition, LAP Porto, the largest Portuguese diagnostic laboratory in the area of women’s health, cooperates with Speculum S.A.

Moreover, the company was mainly involved in the introduction of thin-layer cytology, an improved Pap smear method, which now has over 50% of the market share in Portugal. Since GynTect can be performed based on these improved Pap smears, the prospects are very good for the market introduction in Portugal.

 

GynTect provides rapid and reliable results

GynTect, the molecular biology test developed by oncgnostics, offers an early diagnosis for patients with abnormal Pap test results or evidence of human papillomavirus infection (HPV) to determine the presence of a treatable cervical cancer precursor and the likelihood of developing cervical carcinoma. The test provides rapid and reliable results and gives affected women certain guidance about how to proceed in the face of an abnormal prior examination in the best way. GynTect substantially simplifies risk assessment in the early detection of cervical cancer: on the one hand, it helps to avoid unnecessary premature surgery, and on the other hand, it can increase the chances for successful therapeutic interventions.

 

High death rates for cervical cancer in Portugal

The morbidity rate for cervical cancer in Portugal is higher than in Germany. In Portugal, 9 of 100,000 women develop the disease, compared to 8.2 per 100,000 in Germany. In Portugal, cervical cancer is the second-most common form of cancer among women between ages 15 and 44 years, whereas in Germany, the frequency of occurrence for women of this age puts is in 3rd place. However, the difference in death rates is far greater: in Portugal, 54% of all patients with cervical cancer die of the disease, whereas in Germany, the rate is about one out of three.

“By means of early recognition of cervical cancer, effective treatment can be performed and further complications can be prevented. With GynTect, we are counting on an effective measure in the fight against cervical cancer and its sequelae”, states Antonio Ferreira, Managing Director of Speculum S.A. in Lisbon.

 

Further partnerships planned

Europe-wide CE-IVD licensing for GynTect took place in 2015, opening the way to European partnerships. In the past year, oncgnostics also concluded an exclusive licensing agreement for the Chinese market with GeneoDx, a subsidiary firm of the state-owned Sinopharm Group.

Further partnerships for the internationalisation of GynTect are in negotiation.

 

 

 

About oncgnostics GmbH:

The oncgnostics GmbH was developed in 2012 from a university research group at the Jena University Gynaecology Department. As a molecular diagnostics firm, the Jena start-up has specialised in the early diagnosis of cancer. The tests demonstrate characteristic epigenetic changes in the cancer cells, known as DNA methylations. The patented biomarkers identified with specific algorithms form the central core of the products and are the foundation of the firm.

 

 

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More about GynTect and oncgnostics:

www.mynewsdesk.com/de/tower-pr/latest_media/tag/oncgnostics

and: www.oncgnostics.com/downloads

 

Medirex team in Bratislava

Jena, January 31th 2018 – oncgnostics GmbH partners with the MEDIREX Group. MEDIREX thus holds the exclusive rights for marketing the test for early and reliable detection of cervical cancer, GynTect®, for Slovakia and the Czech Republic.

 

Following their successful crowd-funding via the platform Seedmatch, oncgnostics GmbH takes the next step for internationalization: the company closed a partnership with the MEDIREX Group. The Slovak laboratory diagnostics group has more than 1700 employees, and is the biggest player in lab diagnostics, with >50% market share in the Slovak Republic. The contract has a term for three years, with option for extension.

 

GynTect gives certainty

The molecular test GynTect developed by oncgnostics helps to clarify early and reliably if a patient diagnosed with an abnormal Pap smear or/and with an HPV infection (already) has or develops a cervical precancerous lesion requiring treatment.

“With GynTect we intend to improve the quality of cervical cancer screening in the Czech and the Slovak Republic. GynTect provides fast and reliable diagnostic results and thus women who are affected, certainty how to proceed after abnormal findings from earlier diagnostic measures,“ Jozef Gavlas, CEO of MEDIREX Lab diagnostics states, said.

GynTect drastically improves the risk assessment in cervical cancer screening: on the one hand it allows to avoid hasty and unnecessary surgeries, on the other hand it increases the chance for early, successful treatment measures.

 

Cervical cancer in numbers: Germany, Czech Republic and Slovak Republic

In Germany, ca. 5000 women are diagnosed with cervical cancer every year. Thus 8.2 of 100,000 women get a diagnosis annually. In the Czech Republic and in Slovakia, the disease rates are much higher, at 14.1 and 16.1 of 100,000 women annually, respectively. In all three countries, every third woman with cancer diagnosis dies.

Regular participation of women in cervical cancer screening programs, which are offered in all three countries, may contribute to significantly reduce the morbidity. HPV-induced changes may be detected early, and appropriate measures may be taken. Nevertheless only ca. 50% of all women participate regularly in the annual screening in Germany and the Czech Republic. In Slovakia, where triennial cervical cancer screening is implemented, even less than 50% participate regularly.

 

Further partnerships are planned

GynTect already has CE IVD mark for use in laboratories Europe-wide. Thus, the MEDIREX group immediately may start distribution as well as the use of the test in its own labs. CE IVD mark was received in 2015. In 2017, oncgnostics was able to close an exclusive license agreement for marketing in China with GeneoDx, an affiliate of the governmental Sinopharm Group.

Further partnerships within and outside of Europe are currently negotiated, with the aim to conclude agreements in 2018. The crowd-funding campaign, which very recently was concluded successfully, provided oncgnostics with 750,000 €, which significantly will contribute to plan, negotiate and close further agreements.

 

About oncgnostics

oncgnostics GmbH is a spin-off from the university women’s hospital Jena and was founded early in 2012. As a molecular diagnostic company, oncgnostics is specialized on cancer diagnostics. Oncgnostics tests target epigenetic changes, the 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.

 

 

Contact:

oncgnostics GmbH

Dr. Alfred Hansel

Geschäftsführer

Winzerlaer Str. 2 (Bioinstrumentezentrum)

DE-07745 Jena

Tel. +49 3641 508456

pr@oncgnostics.com

www.oncgnostics.com

 

Media Agentur

Tower PR

Mälzerstraße 3

07745 Jena

Tel. +49 3641 87611-80

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Dr. Xia Xiaokai and Dr. Alfred Hansel, chairman of oncgnostics GmbH. In the background: Yang Xiaoming, chairman of CNBG, Wolfgang Tiefensee, Thuringia's Minister for economics, Dr. Michael Brandkamp, chairman of the High-Tech-Gründerfonds sowie Peter Haug, oncgnostics. photo: Christoph Worsch

Jena, April 5th, 2017: The Chinese pharma company Changchun Jienuo Medical Technology (CJMT), a subsidiary of the Chinese state-owned SINOPHARM Group (www.sinopharm.com/en), has purchased an exclusive license from oncgnostics (www.oncgnostics.com) for marketing GynTect® in China, Hongkong and Macao. The contract comprising four milestones rules the approval of GynTect® at the Chinese Food and Drug Agency (CFDA) within the coming three years. Oncgnostics will receive upfront and milestone payments as well as royalties on future revenues.

 

During a visit of the Chinese partner in the science city Jena the contracts were signed in the presence of the Chairman of the Sinopharm Group, Mr. Jianxin Guo, and of Thuringia’s Minister for Economics, Science and Digital Society, Mr. Wolfgang Tiefensee. “oncgnostics constitutes an exciting example how research in Jena is the basis of a promising business model. The cooperation with the Chinese partner which includes the distribution of the triage test GynTect, is the right and important step for the internationalization of the enterprise and the exploration of the by far largest patient market. This case shows that it is worth to support substantial innovative foundings, which are a main focus of our economic policy”, Wolfgang Tiefensee explained during the signing ceremony.

 

The molecular diagnostic test GynTect (https://www.oncgnostics.com/gyntect-cervical-cancer/?lang=en) clarifies timely if a patient with abnormal Pap smear and/or positive HPV test result develops or already has a cervical cancer requiring treatment. GynTect provides fast and reliable results and thus certainty for women affected. Therefore, risk assessment in cervical cancer screening is significantly improved: on the one hand hasty and unnecessary surgeries can be avoided, on the other hand the chances for obtaining a successful treatment can be improved.

 

GynTect has received CE IVD mark for the EU market already in 2015. Together with its clinical partner at the University women’s hospital in Jena, oncgnostics has driven forward validation of the markers, development of the test format and CE IVD mark of GynTect, using more than 2,000 clinically well-characterized samples. Together with its new partner CJMT oncgnostics intends to enter the enormous market in China. Cervical cancer diagnostics based on HPV screening yields a market potential of >1 bn €.

 

In China, more than 550 million women aged >15 years are at risk of developing cervical cancer. “China has a very high demand for screening and triage tests. GynTect will help us to diagnose cervical cancer and its precancerous stages reliably, in order to prevent unnecessary surgeries and to detect malignant tissue alterations early,” Dr. Xiaokai Xia, director of the Chinese partner CJMT stated.

 

CJMT, a subsidiary of the China National Biotech Group (CNBG; http://en.cnbg.com.cn/html/about/show_1.html), is specialized on clinical diagnostics. Both companies belong to the governmentally held SINOPHARM group (www.sinopharm.com/en), which with more than 100,000 employees and more than $40 bn annual turnover constitutes one of the largest pharma companies world-wide.

 

The exclusive license contract was signed on 5th of April 2017 at the BioInstrumentation center in a top-class event. Wolfgang Tiefensee, Thuringia’s Minister for Economics, Science and Digital Society, welcomed the Chinese delegation comprising of 13 representatives. With Jianxin Guo, Chairman of the Sinopharm Group, Shengyi Shi, Vice President of Sinopharm Group and Xiaoming Yang, Chairman of CNBG, the top-level management of Sinopharm visited Jena. Besides the founders and the management of oncgnostics GmbH, the lead investors of the first two financing rounds High-Tech Gruenderfonds and beteiligungsmanagement thueringen GmbH, represented by their CEOs, Dr. Michael Brandkamp and Udo Werner, respectively, joined the signing ceremony.

 

About GynTect

In Germany 5000 new cases of cervical cancer are diagnosed, and approx.1600 women die from the disease annually. On the other hand, more than 200,000 women receive an abnormal result in the Pap smear diagnosis, the current cervical cancer screening method. Only a minority of these women, however, have a disease requiring treatment, as most of the diagnosed cervical dysplasias (cellular changes) will heal spontaneously. The early detection test GynTect yields fast and reliable results and thus certainty after an abnormal Pap smear and/or a positive HPV test result. GynTect may be performed on residual material from a cervical smear taken for liquid-based cytology. GynTect detects cancer cases with a sensitivity of 100% – all cancer cases included in studies so far yielded a positive GynTect result. The test is based on biomarkers that are present in cervical carcinomas as well as cervical dysplasias that develop into cancer.

 

About oncgnostics

oncgnostics GmbH is a spin-off from the university women’s hospital Jena and was founded early in 2012. As a molecular diagnostic company oncgnostics is specialized on 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 thus the basis for the company’s activities.

 

About Sinopharm Inc. and CJMT

China National Pharmaceutical Group Corp. (CNPGC) known as Sinopharm is a Chinese state-owned enterprise. In 2015, Sinopharm Group had 104.464 employees, annual sales of more than $44bn and was ranked 205 in the global Fortune500 list (http://beta.fortune.com/global500/sinopharm-205).

Jena, November 9th, 2016 – The biotech company oncgnostics (www.oncgnostics.com) will present its new version of the triage test GynTect – a test for the fast and reliable detection of cervical cancer – at the world-leading trade fair Medica. Between 14th and 17th of November 2016 the epigenetics experts will explain the advantages of the test compared to the methods currently available in cervical cancer early detection as well as the new features of the extended GynTect version. The company will also provide information at its booth concerning the current status of its pipeline projects in ovarian as well as head-and-neck cancer diagnostics.

After its successful regulatory approval with CE IVD mark in autumn 2015 oncgnostics continuously refined its cervical cancer triage test GynTect. This new version allows for a much broader range of applications in gynecologic practices and laboratories. GynTect may now be performed directly from a widely used cervical smear medium (PreservCyt, Hologic). This medium allows for both, an advanced form of the microscopic cervical smear examination, the so-called ThinPrep cytology (a version of the Pap test), as well as for HPV tests using the methods developed by different companies. For the first GynTect version a separate cervical smear was required, whereas the new test may now be performed using an already available thin-layer cytology sample. Thus, GynTect also corresponds to the provisions of new guidelines which claim that triage tests in cervical cancer diagnostics need to be performed from the same sample as the initial screening test.

With GynTect oncgnostics has developed a molecular diagnostic test which clarifies early and reliably if a patient with abnormal Pap smear and/or a high-risk HPV infection has a cervical precancerous lesion or cancer that requires treatment. The diagnostic procedure is based on the detection of epigenetic changes in cells of a cervical smear. The emergence of specific epigenetic markers indicates that a precancerous lesion or a carcinoma may be present. Thus, GynTect provides secure test results, which improve the risk assessment in cervical cancer screening: on one hand, unnecessary and hasty surgeries may be avoided; on the other hand true signs of cervical cancer and its preliminary stages may be identified timely. This improves the prospects for early and successful therapeutic measures drastically.

With a team of experts oncgnostics exhibits at the Medica from 14th to 17th of November 2016 at booth E21 in hall 15, a joint stand organized by medways e.V., Jena. On this occasion, the new GynTect will be presented to a large professional audience for the first time. Expert contacts on site are the two managing directors, Dr. Martina Schmitz and Dr. Alfred Hansel. Upon interest in a press interview, please contact us in advance using pr@oncgnostics.com

Medica is THE leading international trade fair and congress for medical technology, electrical medicine, lab equipment, diagnostics and medicines. Ca. 4800 exhibitors from more than 70 countries utilize the Medica as the leading fair for presenting new products and services.

GynTect® is a registered trademark owned by oncgnostics GmbH.

Links:

Find cost-free picture material concerning this press release, the test and the company here:http://oncgnostics.com/downloads

New version of cervical cancer triage test GynTect available

Jena, September 20th, 2016 – GynTect, a molecular diagnostic test developed by the biotech company oncgnostics, allows fast and reliable diagnostics of cervical cancer and the corresponding precancerous stages. The test has been revised now, offering an extension of its application, as compared to the first version. This extended version of GynTect is now available for use in laboratories. Moreover, oncgnostics has launched a crowd-investing campaign that offers small investors the opportunity to participate in the success of the company.

GynTect is a triage test that can be applied in cervical cancer diagnostics. With the fast and reliable results GynTect provides, it is possible to detect if a patient with abnormal result in the currently still most widely used Pap smear, or with a diagnosed HPV infection, has a precancerous lesion or even a carcinoma that requires treatment. This provides a significant improvement in the cervical cancer risk assessment: in the case of negative GynTect results surgeries are avoided, whereas in the case of a positive GynTect result an early and thus successful therapy is possible.

In autumn 2015 GynTect received a CE IVD mark that allows its application in the whole European market. Since then the experts at oncgnostics have continuously developed the test. Its new version allows a significant extension of its application. With this new version GynTect can be performed using smear material collected in the very frequently used liquid-based cytology medium PreservCyt (HOLOGIC). PreservCyt is currently used for an improved microscopic Pap test (ThinPrep Pap test) as well as for HPV tests from different providers (Abbott, HOLOGIC, Roche Diagnostics, Becton Dickinson….). Now even GynTect can be directly made from such a sample, so no additional smear has to be taken for the test.

In the coming months oncgnostics will perform further trials for validation of the new test format, which will support the successful introduction of the internationally patented test in other European as well as Outer-European countries. Fort he Indian market, a distribution partnership has already been closed.

Currently oncgnostics offers small investors the option to participate in the success of the company. With the campaign running at seedmatch.de the biotech startup not only aims at further investments into development, internationalization and distribution, but also into information about cervical cancer, its early detection and diagnostic methods used in this field.

A special feature of the campaign is the co-investment of the VC company bm|t (bm|t Beteiligungsmangement Thüringen GmbH). Through its startup fonds bm|t aims at investing the same sum that is invested by the crowd. This allows a maximum investment of 500,000 € by the bm|t. Furthermore, oncgnostics was able to convince the former world and olympic champion in Biathlon, Andrea Henkel to act as brand ambassador for GynTect.

Already within the first 12 hours the financing threshold of 100,000 € was reached, and in-between half of the finally intended sum was raised. The speed of investments demonstrates the great confidence in oncgnostics’ developments and concepts.

The campaign is running until October 3rd on the Seedmatch platform: www.seedmatch.com/oncgnostics
Find cost-free picture material concerning this press release, the test and the company here: https://www.oncgnostics.com/downloads/

 

About oncgnostics GmbH:

oncgnostics GmbH is a spin-off from the university women’s hospital Jena and was founded early in 2012. As a molecular diagnostic company oncgnostics is specialized on 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 thus the basis for the company’s activities.