Roche announced the U.S. Food and Drug Administration (FDA) approved the cobas HPV test for use on its next-generation cobas 5800 molecular instrument. This new approval is designed to broaden access to HPV testing in mid-size and smaller labs in the U.S. to help enable accurate and timely diagnosis of patients who are at risk of developing cervical cancer.
With the addition of HPV testing, the cobas 5800 supports critical molecular-testing needs with a broad portfolio of infectious disease, sexual health, respiratory, and transplant solutions, the company says.
“Roche’s continued menu expansion of tests like these for use on the cobas 5800 supports our ongoing commitment to provide access to high-medical-value solutions that can help clinicians deliver the best patient care,” says Whitney Green, senior vice president, Molecular & Pathology Lab at Roche Diagnostics. “Expanding access to HPV testing on our new 5800 platform will enable more labs to deliver accurate and reliable results that can lead to the earlier diagnosis of cervical cancer.”
The cobas HPV Test
The cobas HPV test is indicated for use for routine cervical-cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of women to assess the risk for cervical precancer and cancer. The cobas 5800 supports loading primary-collection vials directly onto the compact system, minimizing hands-on time.
The cobas HPV test, originally introduced in 2011 and clinically validated in large, FDA-registrational trials, ATHENA on the cobas 4800 and IMPACT on the cobas 6800/8800, helps healthcare providers identify women at risk for cervical cancer by individually identifying the presence of the DNA of HPV genotypes 16 and 18—the two genotypes responsible for about 70% of all cervical cancers(1)—and reporting the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample.
The cobas 5800 System
The cobas 5800 System is a real-time molecular solution built upon the proven technology platform of the cobas 6800/8800 Systems. The cobas 5800 is designed to provide optimized workflow efficiencies, simplicity and timely results to meet the changing demands of labs of all sizes. Labs are able to test multiple assays simultaneously and receive up to 144 results in an eight-hour shift.
The cobas HPV test is now part of the comprehensive menu of assays for use on the cobas 5800, including cobas BKV, cobas CMV, cobas EBV, cobas HBV, cobas HBV RNA (RUO), cobas HCV, cobas HIV-1, cobas HIV-1/HIV-2 Qual, cobas SARS-CoV-2 Qual, cobas CT/NG, cobas TV/MG, and cobas omni Utility Channel (a dedicated open channel). This comprehensive, high-medical-value menu is now available across all of Roche’s flagship molecular platforms, including cobas 5800, 6800, and 8800.
Featured image: The cobas 5800. Photo: Roche
(1) Li N, Franceschi S, Howell‐Jones R, Snijders PJF, Clifford GM. Human papillomavirus type distribution in 30,848 invasive cervical cancers worldwide: Variation by geographical region, histological type and year of publication. Int J Cancer. 2011;128(4):927–35.