Tag Archive for: Cervical

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.

 

 

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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

 

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