Aptima® HPV Assay

Identify the presence and activity of a high-risk HPV infection

While nearly all sexually active women and men who are not vaccinated will have an HPV infection at some point
in their lives, relatively few will go on to develop cancer. 1 Thus, an optimal screening strategy should identify cervical cancer precursors likely to progress to invasive cancers, while avoiding detection and unnecessary treatment of transient HPV infection and its associated noncancerous lesions.2 With the extension of recommended intervals between cervical cancer screenings, it has become all the more important to accurately identify at-risk patients.

Targeted test

The Aptima® HPV assay targets E6/E7 mRNA and identifies high-risk HPV infections that are present and active.3,4

  • Studies have shown mRNA identifies the presence and activity of a high-risk HPV infection.
  • HPV DNA tests only identify the presence of any of the 14 high-risk HPV types.
  • E6/E7 mRNA expression is indicative of the HPV infections most likely to lead to disease.
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Maximizing the benefits

Studies show the Aptima® HPV assay targets mRNA and provides the exact same excellent sensitivity as DNA-based tests.5-26

Sensitivity5-26
Clinical sensitivity for >= CIN3

Fewer false-positive results10

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While minimizing potential harms10

In the NILM arm of the CLEAR trial, our Aptima HPV test showed 24% fewer false-positive test results compared to a DNA-based test. By minimizing false positives, our test helps clinicians accurately identify patients who require colposcopy.

Designed for sensitive detection of HPV oncogenic activity

  • Aptima® HPV targets oncogenic activity of the HPV virus by detecting E6/E7 mRNA.10
  • Tests that target only the L1 gene are detecting an area that is not needed for disease progression and that can be deleted during integration.27
  • HPV DNA must linearize to integrate into human DNA.27
  • L1 region can be deleted.27
  • HPV assays that only target the L1 region are at risk for false negative results.27
E6/E7 is retained during HPV DNA integration10
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L1-based DNA tests have been shown to miss up to 10%-15% of the most severe disease cases.28,29,30

Comparison of detection strategies

Comparison of HPV tests

Years of long-term results

Studies show the mRNA-based Aptima HPV assay has up to 7 years of continuous follow-up in cervical cancer screening.33,34
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