Molecular diagnostics companies will have to include a machine or transformative step in their patent claims based on the ruling by the Court of Appeals for the Federal Circuit in the Myriad Genetics case. The likely result will be a narrowing of claims, which will make MDx tests more vulnerable to competition.

The CAFC ruled that Myriad Genetics Inc.'s method claims for analyzing the breast cancer 1 early onset (BRCA1) and BRCA2 genes were invalid, although the court did uphold the patents on the genes themselves.