Epi proColon (Epigenomics Inc.)

Focus of the Report: This report evaluates the analytical validity, clinical validity, and clinical utility of the Food and Drug Administration–approved Epi proColon blood-based liquid biopsy test, for the detection of methylated Septin 9 (SEPT9) as cell-free...

FDA Safety Alert

The Food and Drug Administration (FDA) has issued a communication to health care providers regarding the risk of nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices. The FDA has recently become...

FDA Approves New Indication for Nucala

The Food and Drug Administration (FDA) has approved Nucala (mepolizumab; GlaxoSmithKline) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the...

FDA Issues EUA for COVID-19 Antibody Test

The Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for an antibody point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help...