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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.

 

www.oncgnostics.com

 

 

 

Software driven NGS-based diagnostics company Noscendo secures funding to revolutionize the diagnosis of infectious diseases

May 16, 2022 | press

 

  • Series B led by a renowned family office focused on life sciences, with impact-focused VC Revent as co-investor, plus support from existing investors
  • Further development of proprietary DISQVER® technology and international expansion

 

Duisburg, May 16, 2022 – Noscendo, a leading provider of software-driven diagnostic solutions based on NGS (next-generation sequencing) that change the way infection-causing microbes are identified and assessed, has closed its Series B funding round. The round is led by a major life-science focused family office, with Revent, a Berlin-based impact-focused VC fund, as co-investor. Existing investors, including Earlybird Health, Wieland Capital, Paua Ventures and High-Tech Gründerfonds significantly participated in the round. With the fresh capital, Noscendo will scale up its operations, invest in the further roll out of its CE-marked IVD (in-vitro diagnostic) software based DISQVER®-test, further expand its management team, and speed up the development of its product platform in a strive to release further products this year.

 

Using one test, Noscendo’s proprietary DISQVER® platform allows physicians to agnostically detect more than 1,500 different bloodstream-associated pathogens directly from patient samples within 24 hours and adapt treatment accordingly. Such pathogens are responsible for many life-threatening conditions such as infections related to transplantations, major surgical interventions, or sepsis. Here, reliable and early detection is key for survival and appropriate treatment.

 

“With DISQVER®, patients can be treated more quickly in a targeted manner and based on reliable information about the responsible pathogens. This is helpful to both doctors and patients,” said Dr. Philip Stevens, co-founder and CEO at Noscendo. “We are very pleased to have received funding from reputable new investors and continued strong support from our existing investors. We clearly see this as a validation of our clinical and commercial strategy and are determined to further develop our products and services as well as expand geographically,” he added.

 

“Right from the start we have been impressed by the proprietary Noscendo technology and how it helps physicians with identification of pathogens in even very difficult cases. The company has the potential to revolutionize the way people manage health and receive care – one of our investment thesis’ at Revent”, said Otto Birnbaum, Founding Partner at Revent. “The costs for sequencing, and therefore this diagnostics approach, will rapidly decrease in the coming years, allowing increased usage of Noscendo’s technology.”

 

“Earlybird remains a fully dedicated supporter of Noscendo. The company’s product platform combines significant patient benefit with strong health-economic incentives for healthcare providers and payors, thus aligning interests of key stakeholders. Noscendo is a prime example of using the power of data-driven biology to achieve considerable overall impact on healthcare,” added Rainer Christine, Partner at Earlybird Health, who co-led the company’s series A financing round.

 

 

About Revent:

Revent is an early stage (pre-seed to series A) venture capital fund, headquartered in Berlin, investing across Europe in mission-driven founders using technology to drive systemic change across the main investment topics of Climate, Food-Tech, Health, and Economic Empowerment.

 

More information at: https://www.revent.vc

 

 

 

 

 

About Earlybird:

Earlybirdis a venture capital investor focused on European technology companies. Founded in 1997, Earlybird invests in all growth and development phases of a company and supports its portfolio companies with financial resources, strategic support, as well as access to an international network and capital markets. Earlybird invests out of a family of focused and independently-managed funds: Digital West (Western Europe), Digital East (Emerging Europe), Healthcare, UNI-X (University spinoffs), and Growth Opportunity. With EUR 2 billion under management, 8 IPOs, and 30 trade sales, Earlybird is one of Europe’s most established and active venture capital firms. To learn more, please visit: https://earlybird.com

 

 

Presseinformation IKK Südwest: Krankheitserreger schneller erkennen - neues Diagnostikverfahren von Noscendo unterstützt durch die IKK Südwest

1.3.2021     https://www.ikk-suedwest.de/leistungen/praezisionsmedizin-in-der-infektionsdiagnostik-noscendo/

 

 

Amazon Web Services Features Noscendo: Mit AWS Patientenleben retten

24.9.2019

 

Video: https://www.youtube.com/watch?v=mcWLpN1eo_w

 

6230 Abonnenten
Im Duisburger Hafen hat sich das Medizin-Start-up Noscendo niedergelassen, das mit seinen neuen Verfahren die Infektionsdiagnostik revolutionieren will. Mit Hilfe von smarten Algorithmen will Noscendo Erreger von Herzklappenentzündungen und Blutvergiftungen schneller, kosteneffizienter und verlässlicher nachweisen.

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9/2021 - Presentation at BioRiver Boost! 2021 Pitchtraining Düsseldorf

 

Member of Jury and Presentation

"Dr. Peter Haug, Founding Angel - Founding a Start-up Company, Do's and DonT's for Start-ups in Life Sciences"

                                                                                                                                                                  https://www.bioriver.de/bioriver-boost/the-start-up-competition-4

 

8/2020 - Presentation at Rhein-Ruhr Accelerator Life Sciences

 

Presentation

"Dr. Peter Haug, Founding Angel - Founding a Start-up Company, Challenges and Case Examples in Life Sciences

 

https://www.rhein-ruhr-accelerator.de/

 

 

9/2018 - Presentation at Jena-Davis Summer School

 

Presentation at Jena-Davis Summer School on Sep 11, 2018:

Founding a Start-up Company - Challenges and Caseexamples in Life Sciences

 

 

 

 

 

 

 

 

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Further Talks and Presentations

Date Town Event
7.10.2021 Digital Keynote on TK Annual Meeting with TK Deputy CEO
    Thomas Ballast and BioNTech COO  Dr Sieck Poetting
22.9.2021 Dusseldorf Presentation at BioRiver Boost! 2021 Pitches
11.-14.1.2021 Digital JP Morgan 39th Annual Healthcare Conference
     
24.-28.8.2020 Digital Presentation at AMR Conference 2020
16.-17.6.2020 Digital Presentation at Thuringia Investor Days 2020
27.-28.1.2020 Graz Presentation at Health Tech Hub Styria Pitch & Partner
13.1.-16.1.2020 San Francisco J.P. Morgan 38th Annual Healthcare Conference
     
18.-21.11.2019 Düsseldorf Medica 2019
5.-7.11.2019 Frankfurt CPHi 2019
4.-5.11.2019 Mannheim EIT Health Annual Symposium
17.-18.6.2019 Berlin Charité Entrepreneurship Summit
28.-29.5.2019 Bonn High Tech Gründerfonds Family Day
7.5.2019 Berlin Bionnale
8.-10.4.2019 Würzburg Biotech Investors Day & Dt. Biotechnologietage
27.2.2019 Erfurt Außenwirtschaftstag
29.1.2019 Bonn High Tech Partnering Conference
6.-10.1.2019 San Francisco JP Morgan Conference
     
     2018 (Selection)
10.-11.12.2018 Düsseldorf Jury Member European Venture Contest Finals 2018
12.-15.11.2018 Düsseldorf MEDICA 2018
9.-11.10.2018 Madrid CPhI 2018
20.6.2018 Berlin Bionnale
11.-12.4.2018 Nuremberg MedTech Summit
     
     2017 (Selection)
11.-12.12.2017 Düsseldorf Jury Member European Venture Contest Finals 2017
08.-09.11.2017 Munich Roche Future X Healthcare
04.-05.04.2017 Jena Signing Ceremony oncgnostics - SINOPHARM
31.01.2017 Bonn HTGF High Tech Partnering Conference 2017
18.01.2017 Mannheim EIT Health Matchmaking Roche Diagnostics