US health regulators are making it easier for companies to sell genetic tests that assess cancer risk. These tests will now face less strict oversight, moving from the highest regulatory category to a lower one.
Why it matters
For years, new medical devices faced a long and expensive approval process, especially those in the highest risk category. This change means companies developing genetic tests for cancer predisposition can bring them to market faster and with less cost. It shifts the balance, prioritizing patient access and innovation over the most stringent pre-market review.
The signal
Watch for an increase in the number of new cancer predisposition genetic tests entering the market over the next 12-24 months, and whether their prices decrease due to reduced regulatory burden.