Approved for the first line primary screening tool in women 25 years or older to assess risk of cervical cancer based on the presence of clinically relevant high-risk human papilloma virus DNA.
The US Food and Drug Administration (FDA) has approved an expanded indication for an HPV DNA test, making it the first such test that can be used alone for primary cervical cancer screening in women aged 25 years or older.
The cobas HPV Test, detects DNA from 14 high-risk HPV types in cervical cell samples.
A positive test for HPV type 16 or 18 is considered an indication for a colposcopy.
A positive test for any of the 12 other high-risk HPV types is considered an indication for a Papanicolaou test, in order to determine the need for colposcopy.
Provides pooled results for high-risk genotypes HPV 31, 33, 35, 39, 45, 52, 56, 58, 59, 66, and 68 and individual results for HPV-16 and HBV-18, the highest risk genotypes.