Cancer drug tests can now get approved faster, with less paperwork
What happened
US health regulators want to move some cancer drug tests from the highest approval category to a lower one. This means these tests will need less rigorous review before they can be sold.
Why it matters
For years, all new high-risk medical devices, including many advanced cancer diagnostic tests, had to go through a long and expensive approval process. This change means that certain DNA-based tests used with specific cancer drugs can now get to market faster. It could speed up how quickly new personalized cancer treatments become available to patients.
The signal
Watch how quickly new DNA-based cancer tests are approved under these new rules, and whether the number of approved tests increases significantly in the next two years.