Roche’s cobas HPV Test Receives the US FDA’s Approval for cobas 6800/8800 System to Identify Women at Risk for Cervical Cancer

Shots:

• The US FDA approved Roche’s cobas HPV test for use on cobas 6800/8800 systems that enable molecular laboratories to achieve the efficiency and scale needed for meeting the demands of high-volume cervical screening programs
• The approval is based on IMPACT study assessing cobas HPV test in ~ 35,000 women to clinically validate the test for use on the cobas 6800/8800 systems. The goal of cervical cancer screening is to find precancer early to stop the progression of disease
• The cobas HPV test is indicated for routine cervical cancer screening including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of women to assess the risk for cervical pre/ cancer. Earlier, the test was approved for the cobas 4800 System to screen primary cervical cancer without accompanying Pap cytology in 2014

Click here to­ read full press release/ article | Ref: Roche  | Image: Life Science IP Review