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  • Man and woman laboratorians

    cobas® HPV Test

    Risk matters. Deliver 3 results in 1 test for accuracy that your clinical partners expect and that patients deserve      

A new paradigm in the fight against cervical cancer

HPV primary screening algorithm with the cobas® HPV Test identifies more high grade disease than a Pap test alone and maintains screening efficiency

 

This algorithm leverages the high sensitivity of HPV DNA, the built-in risk stratification of HPV 16/18 genotyping and triage with the high specificity of cytology for an optimal balance in cervical cancer screening.

 

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Confidence in HPV DNA Testing

Safety of HPV Test

3-year cumulative incidence rate (CIR) of ≥CIN3 of Pap negative vs HPV DNA negative

 

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A negative cobas® HPV Test provides more than twice the confidence that ≥CIN3 will not develop within 3 years vs cytology alone 

The ATHENA study, the largest US prospective registrational clinical study of its kind, evaluated the performance of the HPV Primary Screening Algorithm with the cobas®  HPV Test in women ages 25+.

Identify Those at Highest Risk

3-year cumulative incidence rate (CIR) of ≥CIN3 by high-risk HPV status

 

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HPV 16 and 18 genotyping allows women to be stratified into distinct groups and managed according to risk

  • 1 in 4 women ages 25+ testing HPV 16+ were diagnosed with ≥CIN3 over 3 years follow-up
  • Nearly 1 in 9 women ages 25+ testing HPV 18+ were diagnosed with ≥CIN3 over 3 years follow-up which is nearly twice the risk of the 12 other hrHPV genotypes combined

Case for Primary Screening Starting at Age 25

≥CIN3 by age group

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28% of ≥CIN3 disease was found in women 25-29 years old

ATHENA data indicates that screening women starting at 25 years with the cobas® HPV Test will help reduce the incidence of high-grade cervical disease

 

Proportion of women with normal cytology (NILM) diagnosed with ≥CIN3 by age group

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Cytology missed >57% of CIN3 in women ages 25-29 confirming the poor performance of cytology alone in younger women 

  • ATHENA data confirms that high-risk HPV testing with HPV 16 and 18 genotyping is superior to cytology alone for first-line primary screening of cervical cancer in both negative predictive value and detecting cervical disease
  • The concern regarding potential over-management of HPV positive women younger than 30 years of age can be addressed by using the HPV primary screening algorithm with the cobas® HPV Test

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