The clearest path to the most meaningful results The cobas HPV Test delivers clinical value with workflow efficiencies every step of the way The cobas HPV Test KNOW THE RISK
Help guide clinical decision making with confidence Clinically relevant information, with a start-tofinish automated and streamlined workflow cobas HPV Test design highlights Simultaneous HPV 16/18 genotyping for 3-in-1 test results Validated as a primary screening test without Pap cytology* Allows for screening and risk stratification in a single test Identifies patients at highest risk of cervical disease Eliminates need for reflex genotyping Real-time polymerase chain reaction technology Proven technology for molecular screening tests PCR technology was used to establish the causal link between HPV and cervical cancer Performance was clinically validated by the land mark ATHENA study Leverages the proven longitudinal safety and protective benefit of a negative HPV DNA result Screening guidelines and algorithms have been designed based on the risk levels conveyed by the presence or absence of HPV DNA Less than 1% of women that tested negative for HPV DNA results developed CIN3 over the next 10 years1 Other non-dna markers have not been demonstrated to convey reduced longitudinal risk of disease Validated for primary screening* The ATHENA trial for the cobas HPV Test was the largest ever U.S.-based registration study for cervical cancer screening (n = over 47,000 women). It validated the test for reflex of atypical squamous cells of undetermined significance (ASC-US) cytology, co-testing of women 30, and as a primary screen in women 25. ATHENA was the first trial designed to validate HPV detection with 16 and 18 genotyping for use as the primary test in cervical cancer screening. Clinical cutoff for the cobas HPV Test was: Selected to maximize the probability that a positive result is also medically significant. Cutoff was validated in ATHENA using detection of high-grade cervical disease as the endpoint, not the number of viral copies, an approach that increases the likelihood that a positive result indicates significant cervical disease (vs a transient HPV infection) 2 Based on histology results from the first ~29,000 ATHENA subjects and validated in the remaining ~18,000 subjects Chosen to achieve a sensitivity of 93% for CIN3+ in the ASC-US population and 90% for CIN2+ in the overall population age 25 *The cobas HPV Test is not approved for primary screening in the US.
The cobas Human Papillomavirus (HPV) Test was designed to provide peace of mind to laboratorians, clinicians, and patients, giving laboratories confidence in the test results they report and enabling clinicians to rely on the precise and accurate information provided to make critical patient care decisions. Further validated by global experts In addition to receiving FDA approval and CE marking based on ATHENA, the cobas HPV Test was further validated to the standards set forth in international guidelines for HPV testing for cervical screening purposes. 3,4 Provides assurance against false results PROTECTS against false negatives β-globin internal control helps prevent false negatives Each sample is tested for the human β-globin gene. HPVnegative specimens with a negative β-globin result are flagged as invalid, helping to prevent reporting of false negative results PROTECTS against false positives AmpErase enzyme helps eliminate false positives Each reaction contains AmpErase enzyme, helping to eliminate false positive results from carry-over contamination by differentiating amplification products from target molecules PROTECTS against false positives No cross-reactivity with non-high risk (hr) HPV genotypes, helping to ensure positive results are clinically meaningful Tested against 25 non-targeted HPV genotypes with no false positivity ELIMINATES ambiguous results No grey zone, indeterminate results, or need for repeat testing Proprietary kinetic algorithm based on 15 years clinical experience manages result calculations; eliminates the need for manual interpretation; and gives precise answers, reporting only positive, negative, or invalid result options
A new standard in laboratory efficiency Automated instrument platform to streamline your laboratory operations Streamlined workflow helps laboratories reduce costs, improve turnaround time, free staff for other critical tasks cobas p 480 Instrument Sample preprocessing prior to cobas 4800 System analysis can also be automated with the addition of a cobas p 480 instrument into the workflow. This instrument takes care of primary vial decapping, vortexing, and recapping, eliminating hands-on time and reducing the risk of repetitive motion injury for laboratory staff. cobas x 480 Instrument On the cobas 4800 System, one HPV test run (94 tests) can be completed in 5 hours (turn-around time) and a single user can run 282 HPV samples (3 x 94) in a day with <1.5 hours total hands-on time. Shortest time to 96 results 5 cobas z 480 Analyzer Hours 7.9 4.9 Cervista HPV HR 6.7 6.0 HC2 High-Risk HPV DNA Test cobas HPV Test Gen-Probe Aptima HPV Test* As the clock above illustrates, the cobas HPV Test can be completed in just 5 hours, vs 6, 7, or 8 hours with competitive tests. *Performed on the PANTHER system. All tests process 96 results.
The cobas HPV Test is performed on the cobas 4800 System, which offers true walk-away automation of nucleic acid extraction and purification and PCR setup, amplification, and detection; and real-time, easy-to-use software that seamlessly integrates the process and data interpretation analysis to help laboratories achieve maximum efficiency. Least time required for daily maintenance 5 cobas HPV Test 3.87 Gen-Probe Aptima HPV Test* 13.94 HC2 High-Risk HPV DNA Test 11.86 Cervista HPV HR 5.21 0 2 4 6 8 10 12 14 16 minutes The cobas 4800 System requires the lowest daily maintenance among all competitors analyzed, taking less than 4 minutes/day. It is also the most convenient of all systems analyzed, as it doesn t require postrun decontamination cleanup of the workstation or other areas as required by other systems. Least amount of hands-on time 5 cobas HPV Test 29.31 Gen-Probe Aptima HPV Test* 36.71 HC2 High-Risk HPV DNA Test 142.71 Cervista HPV HR 125.84 0 20 40 60 80 100 120 140 160 minutes Overall and per reportable, the cobas 4800 System requires the least hands-on time, resulting in the lowest labor time for laboratories. cobas HPV test and cobas 4800 System: Additional benefits 2 1 2 controls per run Only 1 ml of sample required Specimens can be processed directly from liquid-based cytology (LBC) vials Other tests require as many as 8 calibrators and controls Reduces non-reportable results due to insufficient sample volume Collection vials can be directly loaded before or after cytology processing, eliminating the need to transfer aliquots to a secondary vial Ready-to-use reagents Connectivity to laboratory information systems System test assays include HPV and CT/NG, as well as an expanding menu No thawing, measuring, mixing No manual scanning of tubes, allowing user to load run (samples, reagents, disposables) in just 10 minutes Enables broader use of the cobas 4800 System, allowing your laboratory to maximize its investment and potentially save money Every Roche assay is based on our PCR strength and legacy, extensive test design and optimization experience, and commitment to robust performance standards
Deliver three results from a single test Eliminates the need for reflex genotyping while providing clinicians with important patient risk stratification information Flexibility in Reporting Pooled 14 hrhpv types Individual genotyping of HPV 16 and 18 + pooled 12 hrhpv types 16 18 31 33 35 16 18 39 45 51 52 56 58 59 66 68 31 45 33 51 35 52 39 56 58 59 66 68 With the cobas HPV Test, results can be reported as either 14 hrhpv types as a pool, or with individual genotyping of HPV 16 and 18 plus 12 pooled other HPV types. Women positive for HPV 16 or 18 DNA have a higher risk of cervical disease HPV 16 and 18 are the most prevalent oncogenic HPV genotypes and cause 70% of cervical cancers 6 Pap screening alone can miss nearly half the cases of cervical disease in a single round of screening.7 Using HPV DNA testing with 16/18 genotyping as part of routine screening greatly enhances the ability to identify disease in women with normal cytology results 8 1 in 10 women age 30 with normal cytology who were HPV 16 or 18 DNA positive had CIN 3 at baseline 8 1 in 4 women age 25 from the general population who were HPV 16 DNA positive developed CIN 3 over three years 9
The cobas HPV Test offers three high-risk tests in one for confident risk stratification. It s the only clinically validated, FDA-approved and CE-marked assay that simultaneously provides results on high-risk genotypes with individual results on the highest-risk genotypes, HPV 16 and HPV 18. HPV 16 and 18 genotyping adds specificity and further defines risk 3-year cumulative incidence rate of >CIN3 by baseline screening result 9 Cumulative Incidence Rate, % (Confidence Interval) 30 25 20 15 10 5 0 Baseline FU Year 1 FU Year 2 FU Year 3 Follow-up Time (years) HPV 16+ 25.2% (21.7, 28.7) HPV 18+ 11.0% (7.1, 15.4) 12 Other HR+ 5.4% (4.5, 6.4) HPV 0.3% (0.1, 0.7) Women who were HPV 16 or 18 positive at baseline were at the highest risk of developing high-grade cervical disease over a 3-year period (ATHENA primary screening population 25 years). Proven safety of an HPV DNA negative result 10-year cumulative incidence rate of >CIN31 Cumulative Incidence Rate, % (Confidence Interval) 20 15 10 5 0 4.5 15 27 39 51 63 75 87 99 111 119.5 Follow-up Time (months) HPV 16+ 17.2% (11.5, 22.9) HPV 18+ 13.6% (3.6, 23.7) Other pooled HPV+ 3.0% (1.9, 4.2) HPV 0.8% (0.6, 1.1) For more information, contact your local Roche Molecular Diagnostics representative or visit http://molecular. roche.com. In the absence of HPV DNA, there is a very low risk of disease, with 1% of women with a negative HPV DNA result developing CIN3 over 10 years. (Adapted from Kahn et al, 2006, N=20,514.) Cytology negative women have greater than twice the 3-year risk of CIN3 (0.78%) vs HPV DNA negative women (0.34%) 9
The cobas HPV Test is a qualitative in vitro test for the detection of HPV DNA in patient specimens. The test utilizes amplification of target DNA by PCR and nucleic acid hybridization for the detection of 14 hrhpv types in a single analysis. The test specifically identifies (types) HPV 16 and HPV 18, while simultaneously detecting the rest of the hrhpv types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). It is approved for use with cervical cells collected in cobas PCR Cell Collection Media* (Roche Molecular Systems, Inc.), PreservCyt Solution (Hologic, Inc.), and SurePath Preservative Fluid* (BD Diagnostics). Test ordering information Product No. of Tests/Sets Part Number cobas 4800 System Sample Preparation Kit cobas 4800 System Liquid Cytology Prep Kit cobas 4800 HPV Amplification/Detection Kit 240 Tests 960 Tests 240 Tests 960 Tests 240 Tests 960 Tests 5235782190 5235804190 5235812190 5235839190 5235901190 5235910190 cobas 4800 HPV Controls 10 Sets 5235855190 cobas 4800 System Wash Buffer 240 Tests 960 Tests 5235863190 5235871190 cobas PCR Cell Collection Media 250 Vials/Package 5619637190 cobas Sample Prep Buffer 480 Tests 6526985190 Sample Transport Collection Kit (collection brushes) 500 Brushes/Package 4496094190 References 1. Khan MJ, Castle PE, Lorincz AT, et al. 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;97:1072-1079. 2. Rao A, Young S, Erlich H, et al. Development and characterization of the cobas human papillomavirus test. J Clin Microbiol. 2013;5(51):1478-1484. doi: 10.1128/JCM.03386-12. 3. Heideman DA, Hesselink AT, Berkhof J, et al. Clinical validation of the cobas 4800 HPV Test for cervical screening purposes. J Clin Microbiol. 2011;49(11):3983-3985. doi: 10.1128/JCM.05552-11. 4. Meijer CJ, Berkhof J, Castle PE, et al. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int J Cancer. 2009;124(3):516-20. doi: 10.1002/ijc.24010. 5. Data on file, Cobas 4800 Competitive Laboratory Efficiency Analysis. April 2012. 6. Parkin DM, Bray F. Chapter 2: The burden of HPV-related cancers. Vaccine. 2006;24(3):S11-S25. 7. Cuzick J, Clavel C, Petry KU, et al. Overview of the European and North American studies on HPV testing in primary cervical cancer screening. Int J Cancer. 2006:119;1095-1101. 8. Wright TC Jr, Stoler MH, Sharma A, et al. Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV+ cytology-negative results. Am J Clin Pathol. 2011;136(4):578-86. doi: 10.1309/AJCPTUS5EXAS6DKZ. 9. Data on file, ATHENA Study. Roche Molecular Systems, Inc. *The cobas HPV Test is not approved for use with cobas PCR Cell Collection Media or SurePath Preservative Fluid in the U.S. COBAS, COBAS X, COBAS P, and COBAS Z are trademarks of Roche. All other product names and trademarks are the property of their respective owners. 2013 Roche Roche Diagnostics (Schweiz) AG Industriestr. 7 6343 Rotkreuz www.roche-diagnostics.ch