Roche receives FDA approval for HPV test to identify women at risk for cervical cancer

April 21, 2020

Roche 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. 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 4800 HPV Test, originally introduced in 2011 and supported by the ATHENA trial (Addressing the Need for Advanced HPV Diagnostics), 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 percent of all cervical cancers – and reporting the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample. 

Roche received the first FDA approval to use an HPV test for primary cervical cancer screening without accompanying Pap cytology for the cobas HPV 4800 Test in 2014. 

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