Roche gets FDA approval to expand use of HPV test
Roche said on Tuesday that it had received approval from the US Food and Drug Administration (FDA) for the ‘cobas’ human papillomavirus (HPV) test, for use on the fully automated, high-throughput cobas 6800/8800 systems.
The Swiss pharmaceuticals giant said the cobas HPV test identifies women at risk for cervical cancer, by detecting the presence of high-risk HPV DNA in cervical samples.
Persistent high-risk HPV infections could develop into precancerous lesions and, if left untreated, those lesions could progress to cervical cancer, it explained.
It said the goal of cervical cancer screening was to find and treat pre-cancer early, to help stop the progression of the disease.
The cobas HPV test helped 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.
It added that the cobas HPV test, previously approved for the cobas 4800 system, was now part of the “growing menu” of clinically validated, FDA approved tests for use on cobas 6800/8800 systems.
Laboratories would now have the ability to run HPV DNA tests simultaneously with other previously-released cobas tests on the high-throughput systems.
The FDA considered data from the registrational ‘IMPACT’ trial, which enrolled almost 35,000 women in the United States, to clinically validate cobas HPV for use on the cobas 6800/8800 systems.
“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 Roche Diagnostics chief executive officer Thomas Schinecker.
“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.”