Swiss healthcare company Roche has bagged approval from the US Food and Drug Administration to use its cobas HPV test on the fully automated cobas 6800/8800 Systems for detecting cervical cancer in women.
The cobas HPV test has been designed to detect the presence of high-risk human papillomavirus (HPV) DNA in cervical samples from women who are at the risk of getting cervical cancer.
According to Roche, persistent high-risk HPV infections can turn into precancerous lesions that may progress into cervical cancer in women, if left untreated.
Commenting on the cobas HPV test FDA approval, Thomas Schinecker – CEO of Roche Diagnostics 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.
“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 cobas HPV test can identify the viruses that cause almost all kinds of cervical cancers and thus can help women to protect them from the potentially harmful effects of undetected and untreated cervical disease.
The cobas HPV test was previously approved for use with the cobas 4800 System, and the present FDA approval permits the test to be used on the cobas 6800/8800 Systems.
The FDA has indicated the use of cobas HPV test for regular screening of cervical cancer following professional medical guidelines including triage of ASC-US cytology, co-testing with cytology, and HPV primary screening of women to evaluate the risk of cervical precancer and cancer.
The latest approval for the cobas HPV test has been driven by the data from the IMPACT trial (improving primary screening and colposcopy triage trial) in which nearly 35,000 women in the US were enrolled for clinically validating cobas HPV for use on the cobas 6800/8800 Systems.