Test for cervical cancer ideal for clarification in case of positive HPV result

Test auf Gebärmutterhalskrebs durch Studie bestätigt

Independent study in cervical cancer screening:

The GynTect test for cervical cancer screening is highly informative regarding whether cervical cancer is present or likely to develop. In addition, GynTect is well suited for sampling by the patient herself (self-sampling). All these points are confirmed by a recently published study from China.

The Chinese diagnostics company GeneoDx, a subsidiary of the Sinopharm Group, markets the GynTect clarification test under exclusive licence in China. GeneoDx supported a study in which scientists examined the predictive power of GynTect in more detail. The study with the short title “Methylation panel for the clarification of HPV-positive women” has now been published.

Subject of the study

9,526 women from rural areas of China took part. These have difficult access to medical services. For this reason, the women performed the smear sampling for the HPV test themselves. Many of them participated in cervical cancer screening for the first time.

Of the 9,526 women, 1,758 tested positive for HPV. The samples of these women were then tested for HPV types 16 and 18. Furthermore, smear samples were taken by the doctor and GynTect was performed on these samples. The women were also examined by colposcopy and, if necessary, biopsy and continued to participate in the study. They were followed up annually with HPV tests. HPV-positive women again received a colposcopy and, if necessary, a biopsy was taken.

 

“If there is an abnormality, women currently are examined every three to six months. This is not feasible for many in poorly accessible regions. This problem does not only exist in China, but in many regions worldwide. With GynTect, all it takes is a smear test and the women have certainty. This way we can save lives,” explains Dr Martina Schmitz, Managing Director of oncgnostics GmbH.

Study shows potential of GynTect

The study demonstrated that GynTect, with which methylation markers are detected, has very good predictive power, especially in combination with HPV typing: women who were initially both HPV16 or HPV18 positive and GynTect positive had the highest risk of developing the disease. Women who were infected with a different HPV type and were GynTect-negative had the lowest risk.

Based on several references, the authors of the study also assume that GynTect is suitable to be used as a self-sampling test. This means that the women take the sample themselves, which is then sent to a laboratory for testing. The intermediate step via medical personnel is eliminated. In addition, the study concludes that GynTect has the potential to be used in primary screening. The referral rate for colposcopy was reduced by 55.6% through the use of GynTect. Thus, the study also shows that overdiagnosis and overtreatment can be avoided through GynTect.

 

“For us, the study confirms once again that we are on the right track to develop our screening test GynTect into a test that will be an integral part of cervical cancer screening. If we then also develop a reliable self-sampling test, we can revolutionise cervical cancer screening,” summarises Dr Martina Schmitz.

How does cervical cancer develop?

The main cause of cervical cancer is infection with human papillomaviruses (HPV). It takes several years from infection to the development of cancer. Modern screening methods can detect cervical cancer early and treat it well. Deaths are therefore preventable.

Figures for Germany (all figures annually) [1]

  • 6 million women infected with HPV[2], of which several hundred thousand have cytological abnormalities.
  • 4,300 are diagnosed with cervical cancer
  • 1,600 die from cervical cancer

Figures for China (all data annually) [3]

  • Around 110,000 women are diagnosed with cervical cancer
  • around 59,000 die of cervical cancer

How GynTect works

The molecular biological test GynTect, developed by oncgnostics, determines at an early stage whether a patient with an abnormal finding in the cervical cancer screening is developing or already has a cervical carcinoma (cervical cancer) that needs to be treated.

The screening test detects epigenetic changes, so-called DNA methylations. All that is needed to carry out the test is a smear, as is also taken for thin-layer cytology or the HPV test.

Conclusion: GynTect is ideal for clarifying a positive HPV test.

This means that GynTect with its very good predictive power is an optimal clarification option in HPV-based screening. GeneoDx has also recently received approval from the competent Chinese authority NMPA (National Medical Products Administration) for precisely this clarification in an HPV-based screening.

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Free image material: www.tower-pr.com/oncgnostics

[1] Robert Koch-Institut (2018): Zentrum für Krebsregisterdaten. Gebärmutterhalskrebs (Zervixkarzinom): www.krebsdaten.de/Krebs/DE/Content/Krebsarten/Gebaermutterhalskrebs/gebaermutterhalskrebs_node.html

[2] https://www.frauenaerzte-im-netz.de/erkrankungen/humane-papillomviren-hpv/uebertragung-verbreitung/

[3] https://hpvcentre.net/statistics/reports/CHN_FS.pdf?t=1653896959645

 

Photo: Shutterstock.com/Hannamariah

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Cancer diagnostics of the future thanks to highly informative biomarkers

The team of oncgnostics

oncgnostics at Medica 2022:

  • Cervical cancer screening test conquers China

  • Establishing early detection of head and neck tumours

  • First study results for screening test for vulva and vaginal cancer

  • At the joint stand of medways e.V. in Hall 15, Stand K10

Jena / Düsseldorf, November 08, 2022 – oncgnostics GmbH will present its technology, products and current study results at the largest trade fair in the medical sector. The company is an expert in molecular cancer diagnostics. Life-saving early detection is possible with the cancer tests developed by oncgnostics, which are based on patented biomarks.

Cancer diagnostics through biotechnology

DNA methylations form the basis of oncgnostics’ work. Specific changes in the DNA methylation pattern occur when cancer develops or is already present. The tests from oncgnostics detect these changes.

Innovation in cervical cancer screening

GynTect is the company’s first product. Used in cervical cancer diagnostics, the test is already being marketed in several European countries. In August of this year, it was approved in China, where it is marketed under exclusive licence. It is the first methylation test for triage of HPV-positive cases on the Chinese market.

The methylation test in cervical cancer screening

A cervical smear, as it is also taken for thin-layer cytology or the HPV test, is sufficient for the procedure. The test is a decision-making aid on how best to proceed after an abnormal screening result. GynTect not only allows to detect whether a tumour is already present, but also detects cervical lesions that may develop into cervical cancer – years in advance. Thus, risk assessment is greatly facilitated: on the one hand, unnecessary, premature operations can be avoided, and on the other hand, the chance for early and thus promising therapeutic measures can be increased.

ScreenYu Gyn is a further development of GynTect. The diagnostic test, which was CE IVD-approved in May this year, uses only one methylated DNA region, whereas GynTect detects six methylated DNA regions (biomarkers). This makes it particularly well suited for automation. With a simplified and automated test version, countries and regions can be served in which cervical cancer screening has hardly taken place so far. Most new cases of cervical cancer and most deaths due to the disease occur in these countries.

Establish early detection for head and neck tumours

Head and neck tumours are among the five most common cancers worldwide. They often develop unnoticed for a long time because the symptoms are usually unspecific for those affected. So far, no early diagnosis has been established for this group of tumours. oncgnostics is developing a test to change this. In this test, DNA methylation markers identified in cancer tissue and validated by oncgnostics, are detected in the patient’s saliva. The test will initially be used in post-surgical follow-up, as tumour markers that already appear in the primary tumour are also detectable in re-emerging tumours.

Vulva and vaginal cancer: early detection also overdue

Early detection of vulvar and vaginal cancer is also difficult due to non-specific symptoms or no symptoms at all. Initial studies have confirmed that a methylation test with the same biomarkers as for cervical cancer may also be useful here. oncgnostics is continuing to work on diagnostics for the early detection of vulvar and vaginal cancer on this basis.

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About oncgnostics GmbH:

Jena-based oncgnostics GmbH specialises in the early detection of cancer. Its tests detect changes that are characteristic of the DNA of cancer cells. The company, founded in 2012, launched GynTect in 2015. In the context of early cervical cancer detection, the test clarifies whether cervical cancer or precancerous lesions are already present. oncgnostics GmbH is also conducting research into screening tests for other types of cancer. Detailed information is available at www.oncgnostics.com/en.

 

 

Free image material: www.oncgnostics.com/en/downloads

 

Contact:

oncgnostics GmbH

Löbstedter Str. 41

07749 Jena

Germany

Phone: +493641/5548550

pr(at)oncgnostics.com

www.oncgnostics.com

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