US health regulators make it easier to approve tests for inherited genetic disorders

The US Food and Drug Administration is classifying inherited nucleotide repeat disorder DNA tests into a lower-risk category. This means these tests will face fewer regulatory hurdles to reach patients.

For years, new medical devices faced a slow and expensive approval process, even for relatively straightforward diagnostic tests. This change means that companies developing tests for genetic disorders can get them to market faster and at a lower cost. It also means patients might get access to new diagnostic tools more quickly.