Roche has secured approval from the US Food and Drug Administration (FDA) for its cobas HPV test to be used as first-line cervical cancer screening test with SurePath preservative fluid.
The approval allows cobas HPV Test to be used as the first-line screening test for cervical cancer in women 25 and older using cervical specimens collected in SurePath preservative fluid.
The cobas HPV test is claimed to be the only Human Papillomavirus (HPV) test approved to be used as a primary (first-line) screening test with both SurePath and ThinPrep PreservCyt solution.
SurePath and ThinPrep PreservCyt liquid media are used to collect samples for a wide variety of Pap or HPV tests in the US.
With the latest approval, the cobas HPV Test is currently approved for all of the cervical cancer screening indications, including primary screening in women 25 and older, reflex (follow-up) testing of unclear Pap test results in women 21 and older and co-testing with a Pap test in women 30 and older.
Roche Tissue Diagnostics head Ann Costello said: “Before today, laboratories did not have an FDA-approved HPV test available that could cover all of the HPV screening options supported in professional guidelines and be used with both of the primary Pap test collection media.
“With this additional approval for the cobas HPV Test, laboratories and clinicians now have an approved option that can be used for all of their HPV screening indications and sample types, so they can more easily provide the most appropriate options for their patients.”
Launched in 2011, the cobas HPV test will help healthcare providers identify women at risk for cervical cancer by individually detecting the presence of the DNA of HPV genotypes 16 and 18.
The two genotypes are believed to be responsible for around 70% of all cervical cancer.
In 2014, the company secured first FDA approval to use an HPV test for primary cervical cancer screening (without using Pap test).
Clinically validated by the ATHENA study, the cobas HPV test secured approval in the US for use with the cobas 4800 system, which provides walk-away automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve efficiency.