Castle Biosciences，Revolution Medicines获得FDA突破性地位

Castle Biosciences (NASDAQ:CSTL) said on Wednesday that it has received breakthrough device designation from the U.S. Food and Drug Administration for its DecisionDx-Melanoma test. 

The DecisionDx-Melanoma test analyzes gene expression profiles to test stage I-III cutaneous melanoma.

In another development, Revolution Medicines (NASDAQ:RVMD)  announced that the FDA has granted breakthrough therapy status to its cancer drug, elironrasib. 

This treatment is aimed at adult patients suffering from locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutations.

With its breakthrough device/therapy status, the FDA intends to allow timely access to breakthrough technologies with more potential in the diagnosis and treatment of fatal or irreversibly debilitating conditions.

The companies with the designation can receive priority review and interactive communications from the federal agency with regard to device development and clinical trial protocols.