4 The possibility of future advancements in research and regulations
As our understanding of genetics grows, so too will the best available research in this area, and possibly our interpretation of it. Lots of healthcare professionals, Dr Petra Simic included, don’t see this as something that should halt innovation in its tracks. Instead, we should view this as the opportunity to advance and develop; to test our current thinking and improve upon it.
It’s thought that there are over 250 different companies already providing home genetic testing, and the market is set to get even bigger. What’s encouraging is that, in addition to innovation, we are also starting to see improvements in regulation to support patient safety in this growing market.
Regulation around genetic testing was once lacking in a way that helped to support the safe growth of genetic testing in the health and wellbeing space. However, in 2017, new regulations were published relating to in vitro medical devices (IVMDs), which includes genetic tests.
The regulation outlines stricter processes to assess these devices before they reach the market, including the evidence needed to support them. IVMDs currently in development must legally comply with this regulation—and by 2022, the intention is that all products will be of this standard. Of course, there are more questions to be answered and work to be done, but overall, these are encouraging advancements.