Roche Receives FDA Approval for Cobas HPV Test to Identify Women at Risk for Cervical Cancer

  • More than 99 percent of cervical cancers are caused by persistent high-risk HPV infection1

  • Cervical cancer is nearly 100 percent preventable with proper HPV vaccination, screening and treatment; expanding access helps reach more women2,3

  • cobas 6800/8800 Systems deliver full automation, helping laboratories meet the throughput and efficiencies that high-volume, HPV DNA screening programs require

Basel, 21 April 2020 - Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval for the cobas® HPV test for use on the fully automated, high-throughput cobas® 6800/8800 Systems. The cobas® HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples. Persistent high-risk HPV infections can develop into precancerous lesions and, if left untreated, these lesions can progress to cervical cancer.

“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, CEO 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 goal of cervical cancer screening is to find and treat precancer early to help stop the progression of disease. The cobas HPV test helps to protect women from the potential harms of undetected and untreated cervical disease by detecting the virus that causes nearly all cervical cancers.

The cobas HPV test, previously approved for the cobas® 4800 System, is now part of the growing menu of clinically validated, FDA approved tests for use on cobas 6800/8800 Systems. Laboratories now have the ability to run HPV DNA tests simultaneously with other previously released cobas tests on these high-throughput systems.

The FDA considered data from the registrational IMPACT (IMproving Primary screening And Colposcopy Triage) trial, which enrolled almost 35,000 women in the US to clinically validate cobas HPV for use on the cobas 6800/8800 Systems. Study data will be broadly shared, pending publication of the key findings.

[1] Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999; 189:12-19.
[2] Schiffman M, Doorbar J, Wentzensen N, et al. Carcinogenic human papillomavirus infection. Nat Rev Dis Primers. 2016; 2:16086.
[3] Bosch FX, Broker TR, Forman D, et al. Comprehensive control of human papillomavirus infections and related diseases. Vaccine. 2013;31 Suppl 8:I1-31.
[4] World Health Organization,  

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