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There are several types of HPV testing available to clinicians. The two most commonly used are DNA and messenger RNA (mRNA). Unlike HPV DNA testing, which tests for the presence of HPV, mRNA detection allows for the identification of transcriptionally active viruses. Numerous studies have shown that testing for high-risk HPV is more sensitive (high negative predictive value) than cytology for the detection of high-grade squamous intraepithelial lesions (HSIL) (CIN 2 or greater). mRNA testing has been shown to have a higher specificity while maintaining about the same sensitivity to HPV DNA tests by identifying the mRNA transcripts of the HPV E6/E7 oncoproteins from the 14 high-risk HPV genotypes, which mediate the development of cervical cancer. These oncoproteins’ over-expression is associated with a significantly increased risk of CIN and cervical cancer.
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Up until now, molecular testing of cytology specimens for HPV has mainly involved the use of DNA-based assays, in particular the HC2 test.3 However, as HPV is highly prevalent and the lifetime risk for HPV is estimated to be up to 75 percent for sexually active people, more specific biological markers for early detection of cervical cancer are needed. Though current high-risk HPV DNA testing methods generally provide very good sensitivity, specificity is limited (low positive predictive value) as they detect infection by the HPV virus in both their transient and persistent (transforming) states. This leads to positive results in patients who harbor non-transforming HPV infections that might lead to unnecessary invasive procedures such as colposcopy and biopsy in some women. In a study of 800 women referred for colposcopy, the sensitivity and specificity of this test were shown to be >92 percent and 99 percent, respectively, for detection of high-risk HPV types and 91 percent and >55 percent, respectively, for the detection of CIN2+.4 In another study of 1,373 women undergoing routine screening, the sensitivity and specificity for the detection of CIN2+ were 100 percent and 88.3 percent, respectively.5
Aptima® HPV Assay & Aptima® HPV 16 18/45 Genotype Assay
The Aptima HPV Assay: Identifying the presence and activity of high-risk HPV infections.
The Aptima HPV 16 18/45 Genotype Assay:
The next-generation genotype test
The Aptima® HPV assay targets E6/E7 mRNA.
Identifies high-risk HPV infections that are present and active.
Nearly all sexually active men and women will have an HPV infection at some point in their lives. Very few will go on to develop cancer. The Aptima® HPV assay targets high-risk HPV mRNA. The expression of E6/E7 is indicative of the HPV infections most likely to lead to disease. The Aptima® HPV assay maximizes the benefits of screening while minimizing the potential harm.
HPV DNA tests only identify the presence of any of the 14 high-risk HPV types. The Aptima HPV Assay detects E6/E7 viral mRNA from 14 high-risk types of human papillomavirus in cervical specimens (in ThinPrep® Pap Test vials containing PreservCyt® Solution and collected with broomtype or cytobrush/spatula devices).
The test is indicated to screen women ≥25 years with ASCUS cytology (reflex testing) to determine the need for colposcopy, and to screen women ≥30 years for high-risk HPV types. This information with cytology history, other risk factors, and guidelines may be used to manage patients.
The assay is not a substitute for regular cervical cytology screening. The results of this test are not intended to prevent women from proceeding to colposcopy. The assay has not been evaluated for managing HPV vaccinated women, women with prior ablative or excisional therapy, hysterectomy, who are pregnant, or have other risk factors. Aptima and other associated logos are registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States, and/or other countries.
The Aptima HPV 16 18/45 Genotype Assay:
The next-generation genotype test
The Aptima HPV 16 18/45 genotype assay identifies HPV types 16, 18, and 45, which are associated with up to 80% of all invasive cervical cancers worldwide.
When Do Guidelines Recommend Genotyping?
Only for women over 30 with a negative Pap and positive HR-HPV test result.
Benefits of Aptima mRNA
Identify the presence and activity of high-risk HPV infection
The Aptima® HPV assay targets E6/E7 mRNA and identifies high-risk HPV infections that are present and active.
Studies show 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 types.
E6/E7 mRNA expression is indicative of the HPV infections most likely to lead to disease.
Equivalent sensitivity to DNA-based tests with superior specificity
Several studies show the Aptima HPV assay provides the same excellent sensitivity expected from DNA-based tests. Excellent sensitivity means minimizing false-negative results.
The Aptima HPV assay shows superior specificity versus DNA-based testing. The Clinical Evaluation of Aptima mRNA (CLEAR) clinical trial revealed that the Aptima HPV assay had 24% fewer false-positive test results than the DNA-based test.
Minimizing false-positive results helps the clinician target the right patients for colposcopy. This can:
Minimize difficult patient conversations.
Minimize the potential for unnecessary colposcopies and biopsies.
Minimize unnecessary costs to the patient.
Next-generation genotyping
The Aptima HPV Genotyping assay targets types 16 and 18/45, which are associated with up to 94% of HPV-related cervical adenocarcinomas.
Type 45 is the third most common HPV type of invasive cervical cancer globally.
The addition of type 45 identifies more women at risk for adenocarcinoma, with minimal impact to colposcopy.
Years of long term safety
The mRNA-based Aptima HPV assay has up to 7 years of continuous follow-up in cervical cancer screening.