Cancer diagnostic tests can now get to market faster, with less paperwork
What happened
US health regulators are making it easier to approve certain cancer diagnostic tests. These tests, which use a method called in situ hybridization, will now go through a faster approval process.
Why it matters
For years, these specific cancer tests faced the same slow, expensive approval process as entirely new medical devices. This change means manufacturers can bring these tests to market more quickly and cheaply. It could lead to more options for doctors and patients, especially for tests linked to specific cancer treatments.
The signal
Watch for an increase in the number of new in situ hybridization tests coming to market in the next 12-24 months, and whether their development costs decrease.