Tre nya studier visar på fördelarna med mRNA-baserade HPV-test

Christer Borgfeldt, docent och överläkare vid kvinnokliniken på Lunds Universitetssjukhus, presenterar studien om självprovtagning med Hologics mRNA-baserade HPV-test.

HPV-experter från hela världen är på plats på EUROGIN International Congress som just nu pågår i Monaco. I samband med detta vetenskapliga möte kommer Hologic under ett symposium på fredagen att presentera resultaten från tre europeiska studier som visar på fördelarna med mRNA-baserade HPV-test vid screening för livmoderhalscancer – fördelar både vad gäller effektivitet och samhällsekonomi.

En av de aktuella studierna presenteras av docent Christer Borgfeldt, överläkare vid kvinnokliniken på Lunds Universitetssjukhus. Den svenska studien visar på genomförbarheten och den kliniska prestandan av självprovtagning med Hologics mRNA-baserade test av kvinnor som av olika skäl inte deltagit i screening på fem år eller mer.

Vid Hologics symposium presenteras även interimsresultaten av en andra del av studien som utvärderar relevansen av självprovtagning i en population på 6 500 kvinnor över 30 år som inte har screenats på minst 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

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[i]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

[i]Reynolds et al.

[ii]Weston G. et al.

[iii]Ernstson A et al.

[iv]hrHPV meaning highrisk Human Papilloma Virus

[v]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