NEW YORK (GenomeWeb) – Roche today announced that it has received US Food and Drug Administration approval to perform its Cobas HPV test using cervical specimens collected in the BD SurePath preservation fluid using the SurePath vial.
The Cobas HPV test was first approved in early 2011 for screening for cervical cancer in patients age 21 and older with abnormal cervical cytology results, as well as for use adjunctively with normal cervical cytology in women ages 30 and over to assess the presence or absence of high-risk HPV genotypes. Three years later, it was approved as a first-line primary screening test for cervical cancer in women 25 years and older. It runs on the automated Cobas 4800 system.
With the latest approval, the test is now the first FDA-cleared test for use with the SurePath collection medium and vial for processing cervical cancer screening samples, Roche said. The clearance now also includes triage of atypical squamous cells of undetermined significance pap cytology results and adjunct testing with pap cytology for women 30 years of age and older.
"Many labs have a preference in how samples are collected for processing, and this additional approval gives them another clinically validated option for the Cobas HPV test," Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement.
Roche noted that the SurePath preservative fluid is not approved for use with the Cobas HPV test as a first-line, primary cervical cancer screening test.