PDF version: Statement 13 June 2014 (PDF 257 KB)
The Department notes a number of HPV tests are currently being used in Australia. All in vitro diagnostic medical devices (IVDs) supplied prior to 1 July 2010 are provided with a four year transition period (i.e. until 30 June 2014) to be brought into the Therapeutic Goods Administration regulatory framework for IVDs.
It would be expected that all products assessed and used as part of the National Cervical Screening Program would comply with the new regulatory framework. Devices for the detection of Human Papilloma Virus (HPV) on the Australian Register of Therapeutic Goods (ARTG) and approved for supply in Australia are at least Roche Cobas 4800 HPV test (ARTG 187190), Abbott Real Time PCR (ARTG 221520), QIAGEN hc2 High-Risk HPV DNA Test and QIAGEN digene HPV Genotyping Probeset (PS) Test (both included under ARTG 212525), and BD Onclarity HPV Assay and Control Set (ARTG 222940). Others are likely to be added as they become available in the future. Interested persons should check the ARTG status of HPV tests on the ARTG and with the Sponsor.