The Aptima® HPV mRNA
Genotyping Assay for types
16, 18 and 45 gives you
knowledge that’s power.
Aptima HPV mRNA Assay genotyping includes genotype 45 to identify almost all HPV types associated with cervical adenocarcinoma. Evidence shows that the addition of HPV type 45 identifies more women at risk for adenocarcinoma with minimal impact to colposcopy rates.13
Is she at risk for cervical adenocarcinoma?
Although cervical cancer rates are declining overall, cervical adenocarcinoma rates have been increasing for decades.14 One of the benefits of adding high-risk HPV testing to cytology—co-testing—is that it helps identify those patients most at risk for progressing to adenocarcinoma, helping you determine which patients may need to be followed more closely.
HPV type 45:
- Is uncommon and only prevalent in 0.4% of women with normal cytology13
- Is the third most common HPV type in invasive cervical cancer and is associated with 12% of adenocarcinomas13
- Types 16, 18 and 45 show higher carcinogenic potential relative to all other high-risk HPV types15
HPV Genotypes in Invasive Cervical Cancer13
The addition of HPV type 45 identifies more women at risk for adenocarcinoma, with minimal impact to colposcopy rates.
This test is not intended for use in determining the need for treatment (i.e., excisional or ablative treatment of the cervix) in the absence of high-grade cervical intraepithelial neoplasia (CIN). Patients who are HPV 16, 18/45 positive should be monitored carefully for the development of high-grade CIN according to current practice guidelines. The Aptima HPV 16, 18/45 Genotype Assay is not intended for use as a stand-alone assay. The assay should be performed only as a follow-up to an Aptima HPV Assay positive result, and should be interpreted in conjunction with cervical cytology test results. The Aptima HPV 16, 18/45 Genotype Assay is not intended for use in women under age 30 with normal cervical cytology. The Aptima HPV 16, 18/45 Genotype Assay is not intended to substitute for regular cervical cytology screening. The use of this test has not been evaluated for the management of HPV vaccinated women, women with prior ablative or excisional therapy, hysterectomy, who are pregnant, or who have other risk factors (e.g., HIV+, immunocompromised, history of sexually transmitted infection).