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

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NEW! Switching to the Aptima HPV assay could yield significant health economic benefits.11

A Health Economic analysis by Aquarius Population Health [an independent healthcare consultancy] has demonstrated that the Aptima mRNA HR-HPV Assay could save an estimated £11.3 million by averting 25,236 unnecessary colposcopies, 57,758 unnecessary HR-HPV assays and 171,306 cytology tests when compared to DNA assays in the English HPV primary cervical screening programme.11

Dr. Elisabeth Adams [Managing Director and Founder] concluded:

“Using the Aptima mRNA assay versus a DNA assay would almost certainly yield cost savings and reduce unnecessary testing and procedures, benefiting the NHS and women in the Cervical screening programme.” 11

Could you experience these benefits in your region?

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 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.1

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 (Roche) and the negative predictive value (NPV) in cervical samples obtained up to 7 years before detection of CIN3+.

The source was a Swedish biobank with cervical samples from 95,023 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 1,172 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 Aptima HPV assay is proven here.

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

Aptima HPV 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
 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 current HPV DNA benchmark assay (Hybid Capture 2, HC2, Qiagen) in previous studies3,8, 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 excellent sensitivity and improved specificity compared with HPV DNA tests.3,5,8

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 a similar 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 cytology samples were collected in ThinPrep® Pap Test PreservCyt Solution (Hologic) and analysed using liquid-based cytology (LBC), the HC2 test (Qiagen) and the Aptima HPV assay (Hologic).

All those 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.8

Sensitivity and NPV 8

The relative sensitivity of the Aptima HPV assay compared to the HC2 assay 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 the Aptima HPV assay.

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

Specificity 3,5

23% Studies show testing with the Aptima HPV assay could reduce the colposcopy referral rate by 23% compared with HC2.3,5

Specificity was significantly improved by 1.2% when using the Aptima HPV assay vs the HC2 assay (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 with HC2 (2.2: 1.0-4.9) vs the Aptima HPV assay (3.1: 1.7-5.7; p=0.1094) at baseline.

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

HPV Assay Concordance 3

Overall, there was a 97.6% agreement between the 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 excellent sensitivity, longitudinal NPV and a similar risk of CIN3+ as the current benchmark (HC2) at 6 years.3,5

The Aptima HPV assay has statistically the same 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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Comparative performance of human papillomavirus messenger RNA versus DNA screening tests at baseline and 48 months in the HPV FOCAL trial.4,7

Cook et al. Study 7

Four year data further confirms that the Aptima HPV assay has high sensitivity, and significantly improved specificity.

HPV FOCAL is a randomized controlled trial comparing high-risk HPV testing vs. liquid based cytology (LBC) for primary cervical screening.

This study compared the Aptima HPV assay (AHPV, Hologic) and the Hybrid Capture 2 (HC2, Qiagen) assay performance at baseline and 48 months for women in the intervention arm in relation to the rates of cervical intraepithelial neoplasia grade 2 or worse (CIN2+).

Study Design

Women enrolled after December 2010 (n=3,475) were screened at baseline with both AHPV and HC2.

AHPV results were blinded at baseline.

Women with CIN2+ exited the trial and received treatment.

HC2 negative (−) women and those HC2 positive (+) with <CIN2 returned for screening at 48 months with AHPV, HC2, and LBC.

Results at Baseline 4

7.2% were Aptima positive vs. 8.4% for HC2 (p=0.06).

AHPV sensitivity (relative to HC2) for CIN3+ was 100% (95% CI: 82.4–100).

AHPV sensitivity for CIN2+ was 96.0% (95% CI: 86.5–99.0; p=0.15). None of the women who were Aptima negative with CIN2+ at baseline had progressed to CIN3+ at 48 months indicating high negative predictive value (NPV) of 99.7% as demonstrated in other longitudinal studies.5

Specificity

AHPV and HC2 specificities (<CIN2) were 94.1% vs. 93.0% respectively (p=0.05).

Results at 48 months 7

Both AHPV and HC2 had the same CIN2+ and CIN3+ sensitivities (87.5% and 85.0% respectively).

The positivity rates for AHPV and HC2 were 4.8% and 5.2%, respectively (p=0.41).

Of 3,226 baseline AHPV− women, 12/2,858 (0.42%) had CIN2+ vs. 13/2821 (0.46%) for the 3,184 baseline HC2− women.

Colposcopy Referrals

Testing with the Aptima HPV assay would reduce the colposcopy referral rate at baseline by 14% compared with HC2.4

In a population of one million women, 12,000 women would be referred unnecessarily for colposcopy.†4
† based on statistical calculation

Conclusions

AHPV sensitivity (relative to HC2) for CIN3+ was 100%.

AHPV had high sensitivity (96%) for CIN2+ at Baseline and 48 months, demonstrating the safety of a four year screening interval with AHPV.

Compared to HPV DNA, screening with mRNA based AHPV would reduce unnecessary colposcopy referrals by 14% while retaining high sensitivity for true disease detection [CIN2+/CIN3+].

Strengths of the present study include high colposcopy compliance and the ability to assess long-term outcomes, as women in the HPV FOCAL trial can be monitored by an anonymized data linkage process for future disease occurrence through the provincial program screening registry.

This study further confirms the longitudinal performance of the Aptima HPV Assay and reinforces the “tremendous benefits” of the improved specificity.4-6, 8

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  • Want to find out more about the benefits of the Aptima HPV assay? Please provide your details below and a member of our Cervical Health team will be in touch.

  • 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

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 below to download infographics showing the latest data for the efficacy of the Aptima HPV assay

  • 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

  • Want to find out more about the benefits of the Aptima HPV assay? Please provide your details below and a member of our Cervical Health team will be in touch.

  • 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