Roche (cobas

®

) HPV High-Risk Screen

Pathology, Inc. is pleased to announce that we now offer the Roche (cobas®) HPV high-risk screen; (HPV high-risk, including reporting of HPV genotypes 16 and 18). We believe this excellent new technology is a cost-effective and streamlined method to simultaneously detect high-risk HPV and report types 16 and 18 in a single test at the same cost as standard HPV screening.

Advantages of the Roche (cobas®) HPV High-Risk Screen:
  • Detects all 14 HPV High-Risk types* AND reports results for types 16 and 18—all three results in one test at the same price as high-risk screening
  • Excellent sensitivity and specificity
  • FDA-cleared assay—data based on the largest cervical cancer clinical study in the U.S.;47,000 patients enrolled in the ATHENA trial
  • Internal control evaluates sample adequacy
  • Provides a more complete picture—to focus on the few patients who need aggressive follow-up
  • More convenient—1 sample, 1 test, 3 results
*Detects HPV genotypes 31, 35, 45, 52, 58, 66, 33, 39, 51, 56, 59, 68, 16, 18

#5437 Roche (cobas) HPV High-Risk Screen

Component Reference Range
HPV High-risk Screen (14 HR types) Not Detected
HPV 16 Not Detected
HPV 18 Not Detected

Specimen/Stability

ThinPrep® or SurePath™ Liquid-based Pap; stable 21 days 

Schedule

Monday through Saturday

Method

Test performed using Roche Cobas® Real-Time PCR

Report

24-48 hours

CPT Code

87621

Clinical Utility

Human papillomavirus (HPV) high-risk screening for genotypes 31, 35, 45, 52, 58, 66, 33, 39, 51, 56, 59, 68, 16, 18. These HPV high-risk types are associated with cervical cancer.


For more information, please call client services at 877.922.7284.
Visit test code #5437 in the Pathology, Inc. Test Directory


References:

  • Cobas® HPV Test [package insert, U.S.]: Branchburg, NJ: Roche Molecular Systems, Inc. 2011.
  • The ATHENA Study (Addressing the Need for Advanced HPV Diagnostics); Data on File. Roche Diagnostics.
  • www.hpv16and18.com

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