Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer

             Basel, 21 April 2020 - Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval for the cobas ® HPV test for use on the fully automated, high-throughput cobas® 6800/8800 Systems. The cobas® HPV test identifies 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 pre cancerous lesions and, if left untreated, these lesions can progress to cervical cancer.“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 pr oviders 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 goal of cervical cancer screening is to find and treat precancer early to help stop the progression of disease. The cobas HPV test helps to protect women from the potential harms of undetected and untreated cervical disease by detecting the virus that causes nearly all cervical cancers. The cobas HPV test, previously approved for the cobas ® 4800 System, is now part of the growing menu of clinically validated, FDA approved tests for use on cobas 6800/8800 Systems. Laboratori...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news