Early detection of vulvar and vaginal cancer is overdue

Symbolbild: Frauengesundheit, Vulva- und Vaginalkrebs

There is still no targeted method for early detection of vulvar and vaginal cancer. This is despite the fact that an estimated 45,240 women worldwide were diagnosed with vulvar cancer in 2020, and more than 17,000 people even died from it. Vaginal cancer occurs slightly less frequently – with around 18,000 new cases and 8,000 deaths in 2020 worldwide. [1] Oncgnostics has done first approaches for molecular diagnostics using epigenetic markers.

Diagnosis of vulvar and vaginal cancer

The diagnosis of vulvar or vaginal cancer is usually an incidental finding made by a gynaecologist during a gynaecological examination. There is no special test for vulvar or vaginal cancer. This can have fatal consequences, because here, too, the earlier the cancer is detected, the better its chances of being cured.

HPV infection as a risk factor

Infection with human papillomaviruses is considered one of the risk factors for vulvar and vaginal cancer, while some vulvar cancers develop from a skin disease of the vulva called lichen sclerosus. The affected women usually do not experience any symptoms. For this reason, women usually only find out about their HPV infection when they attend their regular check-up at the gynaecologist. HP viruses are widespread. Almost all people get infected with HPV at some point in their lives; it is the most common sexually transmitted infection. But the good news is: In most cases, an HPV infection heals on its own and only in rare cases does it actually develop into cancer. This process can take years. For this reason, good diagnostics could give women the chance to detect cancer early, possibly in its preliminary stages.

Protection against vulvar or vaginal cancer

Women have the following options to protect themselves: They get vaccinated against human papilloma viruses and they go for regular check-ups. There, the gynaecologist not only arranges an HPV test, but also examines visual changes in the vulva and vagina. If the test is positive, further examinations are ordered.

Methylation test for vulva and vaginal cancer

oncgnostics GmbH has investigated the possibilities of a methylation test for the diagnosis of vulva and vaginal cancer. The study is based on the biomarkers of GynTect, a proven test for the early detection of cervical cancer. Since all three types of cancer can be caused by HPV, it is reasonable to assume that these markers also occur in malignant vulvovaginal diseases. This assumption was confirmed in initial studies. Swabs from women with vulva or vaginal carcinomas and their precursors were examined: All carcinoma samples that were HPV-positive were also positive in the methylation test. Dr Alfred Hansel sees the results of the study as a promising approach for the development of diagnostics for the early detection of vulvar and vaginal cancer.

 

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The IVDR (In-vitro Diagnostic Medical Device Regulation)

The new IVDR

The new IVDR (In-vitro Diagnostic Medical Device Regulation) has been in force since 26 May. As a result, numerous companies have had to adapt their approval processes and internal procedures. The new regulations also present oncgnostics with new challenges. For example, the molecular biological cancer tests now fall into the second highest risk level. This means that significantly more requirements have to be met. 

What is the IVDR?

The In Vitro Diagnostic Medical Device Regulation, IVDR for short, is an EU regulation that replaces the previous directive, the In Vitro Diagnostic Medical Device Directive (IVDD). Thus, the IVDR regulates the general safety and performance requirements of in vitro medical diagnostics devices within the European Union. Although the new regulation has already existed since 25 May 2017, it is now mandatory after a five-year transition period. For many companies, the new requirements mean major changes.

The most important changes (selection)

The introduction of the new IVDR is accompanied by several changes. The aim of the new regulation is to improve patient safety.

  • New classification of products into four classes: There are risk classes, ascending from A to D.
  • Common specifications: The EU Commission defines common specifications.
  • UDI system: With the help of the Unique Device Identification, UDI for short, the traceability of each product from the patient via the doctor back to the laboratory is to be guaranteed.
  • Every manufacturer of an in-vitro diagnostic product must install a QM system.
  • Technical documentation: especially the requirements for technical, analytical and clinical performance data have increased in scope.
  • Software: The IVDR now formulates specific requirements for products that contain software.

What the new IVDR means for oncgnostics GmbH

oncgnostics launched GynTect, the screening test for cervical cancer, back in 2015. At the time, this was possible with a CE IVD approval through a self-declaration of compliance. In addition, GynTect fell into the “other” category under the previously valid directive. In the new IVDR classification system, GynTect now falls into the second highest risk level “C”. As a result, the conformity assessment procedure has to be carried out with the involvement of a Notified Body. For products that have already been approved, this means that this must take place in four years at the latest. The same applies to the ScreenYu Gyn test, which was approved only recently, in May 2022.

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