PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is seeking comments from stakeholders on whether certain self-testing in vitro diagnostics (IVDs) should be prohibited from being sold to consumers.

PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.

PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said.

Hesperos Inc.'s human-on-a-chip in vitro model for the first time successfully predicted human response to two drugs. The multi-organ model provided new insight into the drugs' cardiotoxic effects in a study published in Nature Scientific Reports. The Orlando, Fla.-based company also recently demonstrated that its model could simultaneously measure cancer drug efficacy and off-target toxicity without animal models or human testing.