Roche receives FDA approval for HPV test

April 22, 2020

Roche received Food and Drug Administration (FDA) approval for a human papillomavirus (HPV) test, which helps identify women at risk for cervical cancer, according to a news release from the company.

The test is designed to run on Roche’s high-throughput cobas 6800/8800 Systems. The test detects the presence of 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, Roche said.

“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 cobas HPV test was previously approved for the cobas 4800 System.

The FDA considered data from the registrational IMPACT (IMproving Primary screening And Colposcopy Triage) trial, which enrolled almost 35,000 women in the United States 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.

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