The Aptima HPV assay is fast becoming the new Gold Standard in Cervical Cancer HPV Screening.

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The Aptima HPV assay combines excellent sensitivity with unrivalled specificity1-5 and clinical efficacy proven up to 7 years.6-8 Significantly improved specificity has “tremendous implications for improved global public health”6 by delivering less false positive misdiagnosis, less colposcopy referrals, less patient anxiety and unnecessary overtreatment.1-5*

The Aptima HPV assay offers a unique screening approach by targeting high-risk human papillomavirus (HPV) mRNA from the E6/E7 oncogenes.1,9,10 The Aptima HPV assay offers the same excellent sensitivity and improved specificity as compared to DNA-based tests.1-5 Studies have shown that mRNA reflects the presence and activity of a high-risk HPV infection.10 Identifying E6/E7 mRNA is indicative of those HPV infections destined to lead to disease.9,10

Excellent and robust 7-year longitudinal evidence for the Aptima HPV mRNA assay compared with HPV DNA testing.6

Forslund et al. Study 6

New data from a large population-based Swedish study confirms that the Aptima HPV assay is validated with clinical efficacy up to 7 years. This could have tremendous implications for improved global public health by allowing more precise and specific screening.

This study analysed the longitudinal sensitivity of the Aptima HPV assay (Hologic) and HPV DNA assay (cobas® 4800, Roche) and the negative predictive value (NPV) in cervical samples obtained up to 7 years before detection of CIN3+.

Source was a Swedish biobank with cervical samples from 95023 women. Of those, 1,204 women were subsequently diagnosed with CIN3+ (4 months to 7 years after enrolment). These samples were retrieved from the biobank and split tested using the Aptima HPV assay and the HPV DNA assay. Valid tests from both assays were obtained in 1172 samples.

Non-inferior Sensitivity6

Sensitivity of HPV mRNA was non-inferior compared to HPV DNA, regardless of cytology result in women <30 & ≥30 years of age.

Comparable NPV 6

The excellent longitudinal performance of the HPV mRNA assay is proven here.

Sensitivity in detecting CIN3+ in women aged ≥30 years at baseline

Aptima HPV
 mRNA assay

76.3%

95% CI:

65.8–84.3%

HPV DNA
assay

82.5%

95% CI:

72.6–89.4%

Estimated NPVs for 
the absence of CIN3+ after >5 years

Aptima HPV
 mRNA assay

99.97%

95% CI:

99.95–99.98%

HPV DNA
assay

99.98%

95% CI:

99.96–99.99%

Conclusions

Compared with HPV DNA, HPV mRNA testing had similar longitudinal sensitivity for the detection of CIN3+, implying that the Aptima HPV assay can be safely used for primary cervical screening in women ≥30 years.6

The high NPV shown in this study, and higher specificity of the Aptima HPV assay compared with the benchmark HC2 DNA assay in previous studies suggests that the Aptima HPV assay has the potential to allow more precise and specific screening for cervical cancer.6

The Aptima HPV assay can now be considered one of the best validated HPV assays with the same excellent sensitivity and improved specificity compared with HPV DNA tests.5,6,8

Results were statistically non-significantly different.

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6-year negative predictive value confirms longitudinal efficacy of the Aptima® HPV mRNA assay from Hologic® in a routine screening population in Germany.8

Iftner et al. Study 8

New 6-year longitudinal data shows that the Aptima HPV assay has the same excellent sensitivity, but significantly improved specificity compared to Hybrid Capture 2, HC2.

This study compared the innovative Aptima HPV Assay (Hologic) which detects the mRNA of the active virus with the current benchmark (Hybrid Capture 2, HC2, Qiagen).

Study Design

This was a multi-centre, split sample prospective trial. Single cervical samples were collected in ThinPrep® (Hologic) collection medium and analysed using liquid-based cytology (LBC), the HC2 test (Qiagen) and the Aptima HPV assay (Hologic).

All women with a positive result were referred for colposcopy as well as 5% (438) randomly selected from the “triple negative” women as a reference group. 3,295 “triple negative” women 
were re-tested at 6 years.

Sensitivity and NPV 8

The relative sensitivity of Aptima HPV compared to HC2 was 91.5% for CIN3+ and the negative predictive values were 99.8 (99.5-99.9) for HC2 and 99.7 (99.4-99.8) for Aptima HPV.

The data shows that the longitudinal performance of the Aptima HPV Assay over six years is comparable to the performance of the HC2 test.

Specificity 3,5

23% Testing with the Aptima HPV assay would reduce the colposcopy referral rate by 23% compared with HC2.3,5

Specificity is significantly improved by 1.2% using
Aptima HPV vs HC2 (p<0.001).

Risk of CIN3+ at 6 years 8

Cumulative Risks for developing high risk HPV CIN3+ were comparable for 1,000 women who tested negative for HC2 (2.2: 1.0-4.9) vs Aptima HPV (3.1: 1.7-5.7; p=0.1094) at baseline.

The absolute risk of CIN3+ over six years following a negative Aptima HPV result in a screening population is low.

HPV Assay Concordance 3

Overall, there was a 97.6% agreement between Aptima HPV and HC2 assays for the 9,451 samples, with a Cohen’s kappa value of 0.77.

Conclusions

The Aptima HPV assay has conclusively demonstrated the same excellent sensitivity, longitudinal NPV and risk of CIN3+ as the current benchmark at 6 years.3,5

The Aptima HPV assay has unrivaled NPV with a significantly improved specificity meaning markedly less false positive misdiagnoses, less patient anxiety and unnecessary over treatment e.g. colposcopy.3,5

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We look forward to welcoming you to booth 14 at EUROGIN 2018. You are also invited to join the Hologic Satellite Lunch Symposium.

Monday 3 December, 13.00-14.15 hrs, Auditorium II

Moving women’s health forward together; Hologic delivers up to 7 years longitudinal evidence for the Aptima HPV assay

Chaired by & Introduction:

Xavier Bosch, Barcelona, Spain.

Featured Speakers:

The longitudinal clinical performance of the Aptima HPV mRNA assay in comparison to the Hybrid Capture 2 HPV DNA test in two consecutive screening rounds with a 6-year interval in Germany.

Thomas Iftner, Tübingen, Germany

RNA HPV E6/E7 screening: A 3-year longitudinal co-testing study in Madrid. 

Rosario Granados, Madrid-Getafe, Spain.

The Swedish experience with HPV mRNA testing in routine screening and longitudinal performance data up to 7 years.

Ola Forslund, Lund, Sweden

The Aptima HPV assay – the health economic value delivered through reduction in false positives and unnecessary overtreatments.

Elisabeth Adams, London, UK.

Panel Discussion and Questions
Lunch will be provided

*Compared to DNA based tests

  • Please fill in your details to download the infographic

  • Hologic Hub Ltd (Heron House, Oaks Business park, Crewe Road, Manchester M23 9HZ, UK) is the data controller responsible for this contact form.

    Read our Privacy Policy here If you have any questions about this privacy notice or our data protection practices please send an e-mail to data.privacy@hologic.com