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HPV Negatives

 

 

ARE YOU WORRIED ABOUT FALSE
NEGATIVES IN HPV SCREENING?

YOU SHOULD ASK WHAT SHE THINKS.

 

Protect your patients with the clarity that only the cobas® HPV Test offers.

 

The design of the cobas HPV Test

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


Safeguards: feel secure in your sample integrity

The cobas HPV Test contains an internal control for cellularity to detect inadequate or empty cervical samples1

 

What is your safeguard against

  • An empty vial?
  • An insufficient sample?
  • Low cellularity?

 

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: optimized for screening

"In conclusion, the cobas HPV Test was developed with a clinically determined and validated cutoff that maximizes the detection of >CIN2."3

Journal of Clinical Microbiology

 

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


Proven technology: DNA-based amplification is time-proven

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


cobas HPV Test delivers long-term sensitivity

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


Is human error a risk you want to take?

Fewer touch points reduce the margin of error


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.