New STI tests can get to market faster, with less paperwork
What happened
US health regulators just made it easier for new diagnostic tests for sexually transmitted infections to get approved. This means companies can bring these tests to market with less regulatory burden.
Why it matters
New diagnostic tests for serious infections used to face the most stringent regulatory review, which slowed down their release. This rule means companies making tests for sexually transmitted infections and their drug resistance markers will now follow a less demanding approval process. It should lead to more of these tests becoming available, and faster.
The signal
Watch for new diagnostic tests for sexually transmitted infections to appear on the market more quickly in the next few years.