Swiss healthcare firm Roche has received the US Food and Drug Administration (FDA) approval for the cobas HPV test, used on its fully automated, high-throughput cobas 6800/8800 Systems.
The cobas HPV test has been designed to identify women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples.
Continuous infection with HPV would transform into precancerous lesions, and these lesions can progress to cervical cancer in women, if left untreated.
Roche Diagnostics CEO Thomas Schinecker 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.”
cobas HPV test is designed to detect viruses that cause almost all cervical cancers
According to the company, early detection of cervical cancer, before its development would be crucial in prevention and cervical cancer screening would prevent the progression of disease.
Roche said that its cobas HPV test will detect the viruses that cause almost all cervical cancers, and protects women from the potential harms of undetected and untreated cervical disease.
The HPV test was previously approved for use with the cobas 4800 System, and the current FDA approval allows the test to be use on clinically validated cobas 6800/8800 Systems.
In addition, the US regulatory agency has indicated the cobas HPV test for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing with cytology, and HPV primary screening of women to assess the risk for cervical precancer and cancer.
The FDA approval for the cobas HPV test is based the data from registrational improving primary screening and colposcopy triage (IMPACT) trial, which enrolled almost 35,000 women in the US to clinically validate cobas HPV for use on the cobas 6800/8800 Systems.
