EUROGIN 2019 – Tre nye studier viser fordelene ved mRNA-baserede HPV-test

HPV-eksperter fra hele verden deltager i EUROGIN International Congress, som netop nu finder sted i Monaco. I forbindelse med dette videnskabelige møde vil Hologic under et symposium fredag præsentere resultaterne fra tre europæiske studier, som viser fordelene ved mRNA-baserede HPV-test ved screening for livmoderhalskræft – fordele både med hensyn til effektivitet og samfundsøkonomi.

Et af de aktuelle studier præsenteres af docent Christer Borgfeldt, overlæge ved kvindeklinikken på Lunds Universitetshospital. Det svenske studie viser gennemførligheden og den kliniske effekt af selvprøvetagning med Hologics mRNA-baserede test af kvinder, som af forskellige grunde ikke har deltaget i screening i fem år eller derover.

Ved Hologics symposium præsenteres også interimsresultaterne af en anden del af studiet, som vurderer relevansen af selvprøvetagning i en population på 6.500 kvinder over 30 år, som ikke er blevet screenet i mindst fem år.

The annual EUROGIN Congress brings doctors and scientists together, in order to present the latest research on human papillomavirus and to share the medical advances in the prevention of cancers related to this virus. As an expert on women’s health present throughout the entire congress, this year Hologic is organising a symposium, chaired by Professor Jacques Izopet, virologist at the Toulouse Purpan University Hospital, on the occasion of the presentation of the results of three European studies on his HPV RNA test:

• An Irish study[i]that confirms the superiority of the HPV RNA test over HPV DNA tests for screening, with an increase in specificity
• An English study[ii], which demonstrates the benefits in terms of cost-efficiency ratio of RNA-based HPV tests
• A Swedish study[iii]which demonstrates the feasibility and performance of screening carried out with the Hologic HPV RNA test, from self-collected samples of women who did not attend the routine screening for 5 years and longer.

“The studies that will be presented at the symposium on 6 December bear witness to the diversity of cervical cancer screening strategies in Europe," Professor Jacques Izopet pointed out. They demonstrate the good performance of the RNA-based HPV tests and can even confirm the reduction in the number of false positives compared to DNA-based HPV tests (Irish study). It is of interest for patients – because it would avoid irrelevant and anxiety-causing additional examinations - and for the community, thanks to the savings made, as demonstrated by the English study. Finally, the Swedish study focused on the feasibility of self-sampling screening. In the first pilot, a population of 1,000 women aged 69 to 70, who had not participated in the screening for at least 5 years, received self-sampling kits from which the HPV tests were performed. The results showed that self-sampling allows women to avoid having to travel without reducing the performance of the screening.”

A second part of the study explores the relevance of this strategy for a population of 6,500 women aged 30 and over who have not been screened for at least 5 years. The intermediate results of this second component will be presented at the symposium”.

Some reminders about the place of HPV tests in cervical cancer screening
HPV tests make it possible to detect the presence of 14 high-risk papillomaviruses (hrHPV[iv]) the persistent presence of which can cause the appearance of lesions and finally the development of cervical cancer. They are used in several countries as part of national cervical cancer screening strategies – particularly in Italy, Finland, Denmark and the Netherlands. They are usually reserved for women aged 30 years and over.

In France, the national screening programme currently in use was initially based on a smear test every 3 years for all women aged 25 to 65 (i.e. the taking of a sample of cells from the cervix and their examination under a microscope by an anatomical pathologist). However, this is going to change in the light of the latest recommendations from the French Health Authority (HAS)[i]. From now on, for women aged 30 to 65, the HPV test will replace the three-yearly smear test; it will be carried out every 5 years whenever the result of the test is negative.

HPV tests can detect the presence of the high-risk HPV viruses known to be necessary for the development of cancer. At present, there are two types of tests:

• Tests that target viral DNA
• RNA-based tests (particularly those based on the detection of oncogenes E6/E7 mRNA) which detect not only the presence of the virus, but also its activity and limit clinical false positives in comparison to HPV DNA based assay

About Hologic, Inc.
Hologic, Inc. is a company dedicated to innovative medical technologies mainly aimed at improving women’s health and well-being thanks to early detection and treatment.

Forward-looking statements
This press release may contain forward-looking information involving risks and uncertainties, particularly the statements regarding the use of Hologic diagnostic products. We cannot guarantee that products will provide the benefits described here or that these benefits will be reproduced in any particular manner regarding a specific patient, given that the real effect of using the products can only be determined in each individual case. Furthermore, it is impossible to guarantee that these products will be commercially successful or will reach any expected level of sales. Hologic expressly waives any obligation or commitment to publish updates or revisions regarding the statements presented here to reflect any modification to the expectations or any change in the level of the events, conditions or circumstances on which this data or these statements is/are based.

This information is not intended to be an inducement or a promotion for the product when these activities are prohibited. For specific information on which products are available for sale in a given country, please contact a local Hologic sales representative or write to womenshealth@hologic.com.

Hologic, Aptima and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc. in the United States and/or other countries.

Hologic, Aptima and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc. in the United States and/or other countries.

Evaluation of research into human papillomaviruses (HPV) in primary screening of pre-cancerous and cancerous lesions of the cervix and the place of double immuno-staining p16/Ki67, Public health recommendation, HAS, July 2019

Evaluation of research into human papillomaviruses (HPV) in primary screening of pre-cancerous and cancerous lesions of the cervix and the place of double immuno-staining p16/Ki67, Public health recommendation, HAS, July 2019