Protect your patients with the clarity that only the cobas® HPV Test offers.
Help protect women from false-negative results
Provides long-term safety and peace of mind for the patient receiving a negative result with1:
Safeguards against reporting inadequate or empty samples
Clinical cutoffs optimized for screening
Proven technology to detect disease early in its progression
D E S I G N : S A F E G U A R D S
The cobas HPV Test contains an internal control for cellularity to detect inadequate or empty cervical samples1
What is your safeguard against
Beta-globin control in every sample for cellularity to detect inadequate or empty cervical samples, reducing the potential for false negatives.
Aptima REPORTS every missing HPV specimen as "negative"2
D E S I G N : C L I N I C A L C U T O F F S
Clinical cutoffs validated by the largest U.S.-based clinical trial for confidence in YOUR patients' results1
Cutoffs are correlated to disease endpoints to more accurately, reflect risk of progression
As proven in a representative screening population over a three-year period
Greater than 90% sensitivity for high grade disease is achieved in a general population and 93% in an ASC-US referral population at baseline
D E S I G N : T E C H N O L O G Y
Cervical cancer progresses slowly and clinical correlation requires time
"In the natural history of HPV, most infections are transient, especially among younger women; only the small fraction of infections that persist may progress to cervical cancer, usually after more than a decade."4
P A T I E N T T Y P E S : N E G A T I V E R E S U L T S
3-year safety of a negative result
The low risk of disease of a negative cobas® HPV Test at baseline is confirmed with the safety of a negative result over 3 years.1
1. cobas® HPV Test [package insert]. Branchburg, NJ: Roche Molecular Systems, Inc.; 2016.
2. Aptima HPV test [package insert]. San Diego, CA: Hologic Inc.; 2013.
3. Rao A, Young S, Erlich H, et al. Development and characterization of the cobas human papillomavirus test. J Clin Microbiol. 2013;51(5):1478-1484.
4. Khan MJ, Castle PE, Lorincz AT, et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (hpv) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005;97(14):1072–1079.
5. Cuschieri KS, Whitley MJ, Cubie HA. Human papillomavirus type specific DNA and RNA persistence--implications for cervical disease progression and monitoring. J Med Virol. 2004;73(1):65-70.
6. Wright TC, Stoler MH, Behrens CM, et al. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the firstline screening test. Gynecol Oncol. 2015;136(2):189-197.
7. Reid JL, Wright TC Jr, Stoler MH, et al. Human papillomavirus oncogenic mRNA testing for cervical cancer screening: baseline and longitudinal results from the CLEAR study. Am J Clin Pathol. 2015;144(3):473-483.
8. ATHENA clinical trial. Data on file.
COBAS is a trademark of Roche.