Aptima^® HPV & Aptima^® HPV 16 18/45 Genotype Assays

When it comes to HPV Testing, Trust mRNA.

Studies have shown the mRNA tests identify 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.^1,2

DNA vs. mRNA Assays^3,4

E6/E7 Targeting^{1-2, 5}

E6/E7 mRNA expression is indicative of the HPV infections most likely to lead to disease. The Aptima HPV Assay targets E6/E7 mRNA.

Clinical Relevance of the Aptima HPV Assay^3,6-19

CIN2 and CIN3 Detection

Compared with validated DNA assays, APTIMA mRNA was similarly sensitive, but more specific for CIN2+. The Aptima^Ⓡ HPV assay also provides the same excellent sensitivity you’ve come to expect from DNA-based tests for CIN3.

HPV Test Clinical Sensitivity Data for ≥CIN3

HPV Test Clinical Sensitivity Data for ≥CIN2

Choose A Targeted Approach with Aptima 16 18/45 Genotype Assay

A targeted, evidence-based approach ensures timely and effective interventions, improving patient outcomes while safeguarding against overtreatment. Aptima HPV 16 18/45 detects all 14 high-risk HPV Genotypes.³

14 High-risk
HPV Genotypes

Aptima HPV 16 18/45 Genotype Assay

Few HPV+ Cases Will Progress to ≥CIN3²⁰

HPV 16, 18, and 45 Make Up the Majority of Cervical Cancer Cases

HPV type 16 associated with²⁴:

Up to 62% of Squamous Cell Carcinomas
Up to 45% of Adenocarcinomas

HPV types 16, 18 & 45 associated with²⁴:

Up to 80% of Squamous Cell Carcinomas
Up to 92% of HPV-related cervical Adenocarcinomas

HPV type 45^24,25:

Third most common HPV type in invasive cervical cancer
Identifies more women at risk for Adenocarcinoma, with minimal impact to colposcopy

The Stakes are High for HPV Testing

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.⁷

ASCCP Does Not Prioritize Extended Genotyping Over Other Tests²⁶

Pooled detection of non-16/18 genotypes is sufficient.²⁷ ASCCP deemed extended genotyping as “acceptable,” meaning it is one of several options for managing positive HPV results—specifically, it is considered acceptable when evidence shows that another approach is superior, or when there are no data supporting any single option.^26,28

“The current recommendations are intended to guide clinical management among those choosing to use extended genotyping assays; they do not constitute a preference or recommendation for one test or combinations of tests over others. Several alternatives are currently available for risk stratification of individuals who test positive for HPV, including dual stain, cytology, and partial genotyping.”

-ASCCP

Clinical Management for HPV Primary Remains Virtually Unchanged from Today

16/18 immediate colposcopy*

Guidance is to triage to cytology as part of 12 other types with no change to today’s current clinical practice.^†

No data available to support treating any of
the 14 hr-risk types as low-risk

Cytology remains important: 16/18 are still the highest risk with recommendation for immediate colposcopy. Almost all other cases require cytology as a triage regardless of genotype.

* As described in the 2019 ASCCP guidelines, collection of cervical cytology at the colposcopy visit is recommended because additional diagnostic testing and surveillance are required

^† In certain circumstances, patients who test positive for HPV 59, 56, or 66 may be referred to one-year follow-up without cytology/dual stain triage

Aptima® HPV & Aptima® HPV 16 18/45 Genotype Assays

When it comes to HPV Testing, Trust mRNA.

Clinical Relevance of the Aptima HPV Assay3,6-19

HPV Test Clinical Sensitivity Data for ≥CIN3

HPV Test Clinical Sensitivity Data for ≥CIN2

Choose A Targeted Approach with Aptima 16 18/45 Genotype Assay

14 High-riskHPV Genotypes

Aptima HPV 16 18/45 Genotype Assay

Few HPV+ Cases Will Progress to ≥CIN320