Genera Biosystems Receives Approval in Australia for HPV Test Kit
- Posted on 27 January 2010
The Australian Therapeutic Goods Administration (TGA) has approved the entry of Genera Biosystems’ PapType Human Papillomavirus (HPV) test kit onto the Australian Register of Therapeutic Goods (ARTG). The company is now permitted to supply the test kit to Australian customers, subject to the terms of the licence.
The test kit is already on sale through a pre-existing agreement with Healthscope. More widespread availability will follow from a conclusion to partnering discussions.
Genera has appointed Lazard to advise the company on the latter’s transaction alternatives.
The company also announced the completion of the PapType repeatability and reproducibility study with its strategic partner Sonic Healthcare. The study, designed to demonstrate that the kit performed equivalently between different operators, different laboratories and at different times, demonstrated that the product exceeded its targeted study endpoints of 95 percent repeatability and reproducibility.
