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

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Ref: Roche  | Image: Roche