FDA has approved the Cobas HPV test from Roche, Basel, Switzerland, to identify 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 Cobas HPV test is for use with the fully automated, high-throughput Cobas 6800 and Cobas 8800 systems.


Thomas Schinecker, Roche Diagnostics.

“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,” says Thomas Schinecker, chief executive officer of Roche Diagnostics. “This is critical because most healthcare providers in the United States have adopted HPV testing as part of their cervical cancer screening protocol, with the ultimate goal of preventing cervical cancer in all women.”

For more information, visit Roche.