Diagnosing women infected with the human papillomavirus (HPV) often poses a significant challenge to caregivers. Most HPV infections are transient and resolve on their own; however, persistent HPV infection by one of 14 high-risk HPV genotypes can lead to cervical disease.¹ Using the APTIMA HPV Assay can reduce the number of false positive results compared to DNA assays, helping limit the number of families subjected to unnecessary and costly medical procedures.²

Based on published research, the APTIMA HPV mRNA Assay helps physicians differentiate between the presence of a transient infection and an infection more likely to transform into disease, which could reduce the number of false positive results and help determine the best course of treatment.² The APTIMA HPV Assay detects mRNA from the viral E6/E7 oncogenes. Studies show that this test is highly sensitive, yet significantly more specific for cervical disease compared to HPV DNA assays. Testing for mRNA instead of DNA can give clinicians more accurate diagnostic data to help manage their patients.^{3, 4}

The APTIMA HPV Assay is a target amplification nucleic acid probe test for the in vitro qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk HPV types (16/18/31/33/35/39/45/51/52/56/58/59/66/68). HPV mRNA is detected in liquid-based cytology cervical Pap specimens collected in Thinprep vials containing PreservCyt transport solution or in specimens collected with the APTIMA Cervical Specimen Collection and Transport Kit.

The assay can be used with the Direct Tube Sampling (DTS) Systems, the TIGRIS DTS System or the PANTHER System.

References:
¹ Munoz, N.F. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N. Engl. J. Med. 2003, 348:518-527.
² Dockter, J. Clinical performance of the APTIMA^® HPV Assay for the detection of high-risk HPV and high-grade cervical lesions. Clin J Virol Supplement. 2009, 45:S55-S61.
³ Szarewski, A. Comparison of predictors for high-grade cervical intraepithelial neoplasia in women with abnormal smears. Cancer Epidemiol Biomarkers Prev. November 2008; 17(11).
⁴ Cushieri, K. Human Papillomavirus mRNA and p16 detection as biomarkers for the improved diagnosis of cervical neoplasia. Cancer Epidemiol Biomarkers Prev. October 2008; 17(10).

The APTIMA HPV assay is FDA approved for IVD use in the U.S. The APTIMA HPV assay was CE-marked May 9, 2008.

For additional availability in other countries please contact your local sales rep or distributor.

Clinical Performance of the APTIMA HPV Assay for Dectection of E6/E7 mRNA from High-Risk HPV Types in Liquid Based Cytology Specimens Hill; Gen-Probe Incorporated, San Diego, CA. Poster 2009 ISSTDR

Clinical Correlation of APTIMA HPV Assay in Comparison with Hybrid Capture 2 Test in Cervical Cancer Screening Ratnam; Public Health Laboratory, Canada. Poster 2009 ISSTDR

Analytical Performance of the APTIMA HPV Assay on the PANTHER Analyzer Worlock; Gen-Probe Incorporated, San Diego, CA. Poster 2009 ISSTDR

Performance of APTIMA HPV Assay in Referral Population Getman; Gen-Probe Incorporate, San Diego, California. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)

Evaluation of the APTIMA Cervical Specimen Collection and Transport Kit Nugent; Gen-Probe Incorporate, San Diego, CA. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)

Comparison of Three High-Risk HPV (HR-HPV) Tests on ASC Samples with Follow-up Schledemann: Odense University Hospital, Denmark. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)

Performance of HPV E6/E7 mRNA and DNA Tests for the Detection of CIN or Worse: Results from a Multicentre Canadian Study Ratnam; Public Health Laboratory, St. John's, Canada. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)

Results of the French APTIMA HPV Screening Evaluation (FASE Study) Monsonego; European Institute of the Cervix, Paris, France. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)

Detection of HPV mRNA in Cytology Specimens with the APTIMA HPV HPV Assay Clad; Universitaets-Frauenklinik, Freiburg, Germany. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)

Does RNA Testing Detect Clinically Significant HPV Infection? Cuschieri; Royal Infirmary of Edinburgh, Scotland. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)

HPV mRNA and p16INK4a as Triage Markers in Cervical Cytology Reuschenbach; University of Heidelberg, Heidelberg, Germany. Abstract 2009, 25th International Papillomavirus Conference and Clinical Workshop (IPV)

Detection of High-Risk HPV mRNA in Liquid Based Cytology (LBC) with the APTIMA HPV Assay Clad: University Hospital, Freiburg, Germany. Oral Presentation 2008 EUROGIN, Nice, France

Performance of the APTIMA HPV Assay for detection of high-risk HPV mRNA in Liquid-Based Cytology Specimens Dockter: Gen-Probe Incorporated, San Diego, CA. Oral Presentation 2008 EUROGIN, Nice, France

French APTIMA HPV Screening Evaluation (FASE) Interim Results Monsonego; EUROGIN, France. Oral Presentation 2008 EUROGIN, Nice, France

Relative Performance of HPV DNA and E6/E7 mRNA Tests in Cervical Cancer Screening: Preliminary Resutls from a Multicentre Canadian Study Ratnam; St. John's, Newfoundland,Canada. Oral Presentation 2008 EUROGIN, Nice, France

Performance of the APTIMA HPV Assay in ASCUS Specimens Smith; University of North Carolina, Chapel Hill, NC. Oral Presentation 2008 EUROGIN, Nice, France