FDA Approves cobas HPV Test for Measurement of Cervical Cancer Risk in Women with High-Risk HPV

The FDA has granted approval for the cobas high-risk human papillomavirus (HPV) test, which identifies women at risk for developing cervical cancer by exposing the presence of high-risk HPV DNA in cervical samples. Left untreated, HPV lesion can progress to cervical cancer, Roche announced in a press release.¹

“The approval of our HPV test for the cobas 6800 and 8800 Systems enables molecular laboratories to achieve the efficiency and scale they need to meet the demands of high-volume cervical screening programs,” said Thomas Schinecker, chief executive officer, Roche Diagnostics. “This is critical as most healthcare providers in the US have adopted HPV testing as part of their cervical cancer screening protocol, with the ultimate goal of preventing cervical cancer in all women.”

The FDA’s decision was based on information from the registrational IMPACT (IMproving Primary screening And Colposcopy Triage) trial, in which 35,000 women were enrolled to evaluate the clinical validity of the cobas HPV test for use on the cobas 6800/8800 systems. The data from the evaluation with be announced to the public once the key findings are published.

cobas HPV previously underwent clinical validation on the cobas 6800 System for cervical screening of women in comparison with cobas 4800 HPV. The study included 60 patients cases. Of those patients 59 were determined to be HPV-positive patients according to the cobas HPV test. The clinical sensitivity was 98.3% (95% CI, 91.1%-99.9%). The cobas 4800 HPV has a sensitivity of 100% (95% CI, 939%-100%).²

In terms of specificity, 712 out of 805 controls were found to be negative for HPV on the novel cobas HPV test, showing a clinical specificity of 88.4% (95% CI, 86%-90.6%). For the cobas 4800 HPV test specificity was 89.4% (95% CI, 87.1%-91.5%). Specificity for histologically confirmed CIN2-positive lesions in women aged 30 years or older with the novel cobas HPV test was 98.9%. Comparing the novel test to the 4800 test, 11.6% vs. 10.6% of the controls were positive for HPV. Of those that tested positive tested positive with the novel test but were negative on the cobas 4800 test, the strands of HPV found were HPV16 (n = 5), HPV18 (n = 2), and HPV16/18 (n =1). All 8 control samples were still negative when retested with the cobas 4800 test.

The results were considered reproducible for both test with an interlaboratory reproducibility of 98.2% (491/500; 95% CI, 96.6% to 99.2%), over time and an AC1 value of 0.97.

Based on this study, the clinical performance of the cobas HPV test was considered comparable to other validated HPV assays and met the criteria for use in primary screening for cervical cancer.

The cobas HPV test was approved by the FDA the cobas 4800 System. The assay is 1 of multiple tests with clinical validity for detection of cervical cancer in patients with HPV. The assay is indicated for routine cervical cancer screening according to professional medical guidelines which include triage of ASC-US cytology, co-testing with cytology, and primary HPV screening of patients.

It is known that over 99% of cervical cancer cases are caused by persistent high-risk HPV infection, but these cases are preventable with vaccination, screening, and treatment. The use of the cobas HPV test may prevent the development of cervical cancer in women who are at high-risk.

^References:

1. ^{Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer [news release]. Basel, Switzerland: Roche; April 21, 2020. https://bit.ly/2KouRnC. Accessed April 21, 2020.}
2. ^{Saville M, Sultana F, Malloy MJ, et al. Clinical Validation of the cobas HPV Test on the cobas 6800 System for the Purpose of Cervical Screening. J Clin Microbiol. 57:e01239-18. https://doi.org/10.1128/JCM.01239-18.}