A new paradigm in the fight against cervical cancer
HPV primary screening 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.
Hear the physicians perspective on primary screening:
Now recommended by medical societies as an option for cervical cancer screening
Cervical Cancer Screening: A Change in the Air?
Since the FDA announced the approval of HPV testing as the primary screen for cervical cancer, there has been considerable discussion in scientific journals and in the media. Listen to Dr. Thomas C. Wright's Expert Interview surrounding the key issues at ReachMD and receive free CME credit.
Listen to the Interview >
Confidence in HPV DNA Testing
Safety of HPV Test
3-year cumulative incidence rate (CIR) of ≥CIN3 of Pap negative vs HPV DNA negative
A negative cobas® HPV Test provides more 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 and older.
Identify Those at Highest Risk
3-year cumulative incidence rate (CIR) of ≥CIN3 by high-risk HPV status
HPV 16 and 18 genotyping allows women to be stratified into distinct groups and managed according to risk
- 1 in 4 women ages 25 and older testing HPV 16+ were diagnosed with ≥CIN3 over a 3 year follow-up period
- Nearly 1 in 9 women ages 25 and older testing HPV 18+ were diagnosed with ≥CIN3 over 3 year follow-up period which is nearly twice the risk of the 12 other hrHPV genotypes combined
HPV Primary Screening Starting at Age 25
≥CIN3 by age group
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
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