Roche’s test to detect women at risk for cervical cancer gets FDA approval

Roche got approval from US Food and Drug Administration (FDA) for the cobas HPV test for use on the fully automated, high-throughput cobas 6800/8800 Systems which 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.

Thomas Schinecker, CEO Roche Diagnostics said that the approval of Roche’s 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. He said that 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.

Roche said that 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, Roche said.

The drugmaker further said that 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 company added.

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