Tag Archive for: diagnostics

Dr. Carolin Dippmann and Daria Meyer from our research and development team work, among other things, with the “third-generation sequencing” method. With the help of this technology, they are examining DNA (deoxyribonucleic acid) from tumors much more precisely than was previously possible.

The method has enormous advantages: epigenetic changes in the DNA, specifically DNA methylation in certain regions, tell us when healthy cells develop into cancer. And with “third generation sequencing” we can detect these changes directly.

Our goal at oncgnostics is to detect such epigenetic markers. Especially in the early detection of head and neck tumors, development is still in its infancy. In various research projects, including the OroCa-Graz study, we are working together with clinicians on a standardized screening to detect the associated diseases earlier and more reliably than before.

In the following, the two scientists explain to what extent third-generation sequencing is being used and what exactly is behind it.

How does Third Generation Sequencing work?

Part of our daily work is to screen DNA fragments for epigenetic changes, specifically DNA methylation. DNA methylation at specific base sequences indicates that the cell in question has changed.

Third generation sequencing is a method that makes these analyses faster and more effective. In addition, the method provides the DNA sequence information in very high resolution: namely, individual DNA molecules are analyzed. The biological DNA is transferred into a digital version and can be analyzed on the computer. DNA methylation, which occurs during cancer development, can be analyzed directly. And this is of particular interest to us.

The process is illustrated in a video from “Oxford Nanopore Technologies” on YouTube.

How does the method differ from previous methods?

With previous sequencing methods, we could only determine the base sequence of short DNA fragments (300 DNA bases on average). In addition, the DNA to be examined had to be copied several times in advance, very similar to the so-called PCR method explained here. In addition, the DNA had to be chemically treated to detect DNA methylation.

The Third Generation Sequencing method simplifies this process:

  • We can directly evaluate DNA molecules of up to several million DNA bases in length
  • No copies are necessary for this. Rather, we evaluate the individual DNA sequences directly
  • The speed with which we examine the sequences increases accordingly: We now collect the data in real time

What kind of data do we get?

The bottom line is that the Third Generation Sequencing method captures changes in current and records them digitally. It works like this: The DNA to be examined is placed on a surface that is under a specific voltage. Tiny pores made of proteins are embedded in this surface. During the process, the DNA migrates, always in the same direction, through these so-called nanopores. This is why the method is also called “Oxford Nanopore Technology” (ONT).

When the DNA migrates through a pore, the current intensity on the surface changes. This is due to the spatial arrangement and chemical properties of the DNA segments. Sensors measure these changes at each individual pore and transmit them to the computer connected to each. An algorithm then translates the information into the base sequence of the DNA. In the sequence recorded we also read the DNA methylation.

Are there any other advantages or disadvantages?

Since the method is still very new, it has a fairly high error rate. Currently, it recognizes only 95 percent of all sequences without errors. With other methods, the figure is 99.9 percent. Continuous developments will improve this over time. Daria Meyer’s work is part of this. She is a bioinformatician and, as part of her PhD thesis, she focuses on improving the algorithms that are essential for analyzing DNA methylation. In addition, we are constantly optimizing the process flows in the preparation of diagnostic samples. That is Carolin Dippmann’s focus in the project.

In fact, the advantages outweigh the disadvantages. One of the reasons for this is that the analyzer is barely larger than a USB stick and therefore super handy. Theoretically, sequencing can be carried out anywhere, from the Arctic to the desert.

What is our future benefit from Third Generation Sequencing?

With the help of ONT sequencing, major gaps in our knowledge of the human genome (the entire DNA sequence of a human being) have already been closed. We expect further developments in this area. And we are happy contribute to improving the technology.

The biggest advantage for us is the direct readability of epigenetic changes, i.e. DNA methylation. We can analyze these directly at our facility.

The method is gaining acceptance in more and more areas of application. This is not least due to the fact that the initial equipment for starting sequencing projects is very inexpensive. Sequencing of this quality is thus much more affordable. This means that small companies like oncgnostics can also utilize this technology.

The biotechnology company oncgnostics GmbH is researching a method for diagnosing Head-and-Neck tumors together with the clinical department for general ENT at the Medical University of Graz as part of the “OroCa-Graz” study. 550,000 people worldwide develop carcinomas of this type every year. As only advanced stages of tumours are often diagnosed, more than 300,000 of those affected die each year. The study aims to demonstrate that the diagnostic method developed for Head-and-Neck tumors and especially mouth and throat cancer (= oropharyngeal cancer) can reliably and early detect malignant tumors using non-invasive saliva samples.

Excessive alcohol and tobacco consumption are among the main risk factors for Head-and-Neck cancer. In addition, there has been an increase in cases of carcinoma in the mouth and throat area in recent years, in which infection with the human papillomavirus (HPV) was found. The rate of these HPV-associated cancers increases by 2.1 percent annually. Non-HPV-associated Head-and-Neck cancers decreased slightly by 0.4 percent over the same period[1]. In Germany, a current proportion of 40 percent of HPV-induced diseases is assumed, and the trend is rising[2].

The “OroCa-Graz” study is led by Prof. Dr. Dietmar Thurnher, Head of the General ENT Department at the Medical University of Graz. He explains: “Despite increasing cases, the treatment of Head-and-Neck cancer has not made any significant progress in the last 20 years. Beside new diseases, half of the patients return as so-called tumor recurrence within the two years after completing therapy. Furthermore, no early diagnosis has yet been established for Head-and-Neck tumors. Our goal is to change that. By examining the relationship between oropharyngeal carcinomas, HPV infections and DNA methylation markers, new ways of early diagnosis as well as secondary and tertiary prevention are emerging.”

Secondary prevention is aimed at people with an increased risk of disease, for example smokers. With preventive examinations, clarification as well as screening tests, malignant diseases, especially in risk groups, could be diagnosed at an early stage or abnormalities could be clarified. Until now, the throat is inspected when symptoms arise. Tertiary prevention measures are aimed at tumor patients who are in regular clinical follow-up after treatment.

“OroCa-Graz”: Course of study

As part of the “OroCa-Graz” study, tissue and saliva samples from patients with oropharyngeal cancer are examined comparatively. By submitting a simple saliva sample, complaints in the head and neck area should be clarified later. The detection of a malignant disease is carried out via the detection of tumor-specific DNA methylation markers, which were developed by oncgnostics. The HPV status of all samples is also determined. Based on these results, the scientists analyse how sensitive the tumor detection by the methylation markers is and whether there is a connection between the occurrence of the tumor markers and an HPV infection.

Additional saliva samples are taken during follow-up. The idea is that tumor markers that have already been detected in the primary tumor return in the development of recurrences. If the tumor markers are detected in the follow-up, action can be taken at an early stage.

Research on DNA methylation markers since 2012

Since its foundation in 2012, oncgnostics GmbH has been specifically engaged in the search for DNA methylation markers, including Head-and-neck tumors. So far, a set of potential tumor markers based on tissue and swab samples has been established for the disease. One of these tumor markers is already used in the diagnosis of cervical cancer in the GynTect® test.

“Changes in the DNA methylation pattern occur early in tumor development. By detecting our cancer-specific biomarkers, we can check, for example, if cancer precursors are present. In the future, the application could be a powerful tool for early detection in the context of cancer screening and as part of the follow-up examinations for oropharyngeal carcinomas,” said Dr. Martina Schmitz, CEO of oncgnostics GmbH.

[1] Universität Leipzig (2020): Oropharynxkarzinom: Gute Prognose – aber nicht für alle Patienten. Online available: https://www.quintessence-publishing.com/deu/de/news/nachrichten/bunte-welt/oropharynxkarzinom-gute-prognose-aber-nicht-fuer-alle-patienten

[2] Wagner S. et al. (2018): Das HPV-getriebene Oropharynxkarzinom – Inzidenz, Trends, Diagnose und Therapie. In: Der Urologe 57:1457–1463. Online available: https://pubmed.ncbi.nlm.nih.gov/28713770/

2020 was a challenging year – also for our company. Nevertheless, we look back on successful achievements.

GynTect® convinces in test comparison

In November, the journal Clinical Epigenetics published a comparative study on cervical cancer diagnostics tests. Two tests based on epigenetic markers, oncgnostics’ GynTect® and QIAGEN’s QIAsure, were tested on a selection of patient samples. Both tests may be used to identify clinically relevant, HPV-induced cervical disease that may develop into cancer. The aim of the study was to determine not only the sensitivity but also the specificity of the tests, which means how frequently a test delivers a false-positive result. Both tests demonstrated a very good sensitivity for high-grade lesions, especially for cancer cases. However, for GynTect®, the specificity was significantly higher, which means that the rate of false-positive results among healthy HPV-positive women was much lower. Thus, GynTect® may be preferable, due to its higher specificity for CIN2+ or CIN3+.

Achievements: active in research despite Corona

In August 2020, a study on psychological stress in connection to abnormalities found in cervical cancer screening was published, with our contribution. More than 3700 women participated in this scientifically supported online survey. Women with abnormal Pap smear findings or with an HPV infection stated, among other concerns, that they are worried about developing cancer. Even though neither an abnormal Pap smear finding nor an HPV infection does provide a reliable indication of cancer. Nearly half of those affected even expressed fears of dying from cervical cancer. The results were published in the journal Archives of Gynecology and Obstetrics.

Furthermore, we have made significant progress in the diagnostics of Head-and-Neck tumors: Since 2019, we have developed a test based on proprietary DNA methylation markers that may be used in Head-and-Neck cancer diagnostics. In 2020, the corresponding study “OncSaliva” started in the University Hospital Jena. Four more centers will be added by the end of the first quarter of 2021. A total of 150 patients provide saliva and blood samples at the time of their cancer surgery. In addition, we obtain tissue samples from the tumor for analysis. The samples are tested for the methylation markers. 150 healthy subjects are also included, from whom tissue and saliva samples are collected. During the subsequent post-surgical follow-up care, the patients enrolled in the study regularly provide saliva samples for recurrence detection for up to two years. Our scientists analyze the methylation markers in the saliva. This non-invasive method may enable a timely detection of recurrences in the follow-up. The study will run until the end of 2023.

Outlook for 2021: New cooperation and appearance at Eurogin

The results of the GynTect®-PRO study will be available in May. Our company started a three-year follow-up study with the GynTect® test procedure in 2017. For this trial, patients from ten study centers in Germany were enrolled. It is intended to show that young patients with a negative GynTect® result do not develop cervical cancer despite conspicuous changes observed at the cervix uteri. Instead, the cell changes heal by themselves.

In 2021, we will reach another milestone in our international sales activities. Our company recently negotiated a partnership with the international diagnostics group EUROIMMUN, a PerkinElmer company.

Save the Date: We will participate at the international, multidisciplinary HPV congress Eurogin from May 30th to June 1st 2021.

 

Picture: Pharmaceutical biotechnologist Theresa Erler in the oncgnostics laboratory / © Eberhard Schorr

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

The oncgnostics managers together with Geneo Dx managers and colleagues.

Dr. Martina Schmitz and Dr. Alfred Hansel, our CSO and CEO, have just come back from a visit in China, with days full of exciting events, dates and a few hours for sightseeing.

Shanghai at night

Shanghai at night

 

 

 

 

 

 

 

 

Shenzhen – Finals of the “Innovation & Entrepreneurship International Convention (IEIC)”

Having reached a second place at the European finals in Berlin, we were invited to participate in the IEIC Shenzhen. There, Alfred Hansel had the opportunity to present oncgnostics, to visit several science and technology parks and incubators, and to discuss cooperation options.

Shanghai – China International Medical Equipment Fair (CMEF)

Whereas Alfred Hansel visited Shenzhen, Martina Schmitz attended the international tradefair for medical technology CMEF in Shanghai. More than 4,000 exhibitors showed their latest developments and newest products to ca. 500,000 visitors. The chinese oncgnostics partner GeneoDx also had a booth – and presented our test GynTect!

CMEF

Luxiang Cheng, Business Development Manager at GeneoDx, and Dr. Martina Schmitz in front of the GynTect Roll-Up

 

 

 

 

 

 

 

 

 

Visit at GeneoDx

Finally, Martina Schmitz and Alfred Hansel visited our license partner GeneoDx. The contract for the exclusive cooperation concerning GynTect was signed a year ago, when GeneoDx still had its old name CJMT. Along with the renaming, GeneoDx moved to new facilities in Shanghai.

In the new facilities, GeneoDx has established the production of GynTect, and the CFDA has approved this production. Now GeneoDx will have to perform trials that are required in order to get final approval for the test. We discussed the trial design, in order to help GeneoDx design a trial protocol that may be discussed with the authorities. We also discussed options for further cooperation beyond GynTect.

„We could spend a lot of time with our partners at GeneoDx, and we were glad to meet some of the people again whom we had shown how to produce and how to perform GynTect last year in our labs. It was exciting to visit their new research labs as well as the GynTect production facility“, Martina Schmitz said.

The oncgnostics managers were then invited to get a taste of the typical Chinese cuisine, before they took their way back to Germany after some really exciting days.

Traditional Chinese Meal with the Colleagues from Geneo Dx.

Traditional Chinese Meal with the Colleagues from Geneo Dx.

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.

 

 

Free pictures and download material for your distribution: bit.ly/2ymMw6H

More about GynTect and oncgnostics:

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

and: www.oncgnostics.com/downloads

 

Tag Archive for: diagnostics

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