Cepheid (CPHD) Announces FDA-Clearance for Global Marketing of Blood Clot Test
Cepheid, a diagnostics company focused on the biothreat market, last week made a joint announcement with Instrumentation Laboratory (IL), a worldwide developer, manufacturer and distributor of vitro-diagnostics instruments, reporting that Cepheid has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(R) HemosIL(R) FII & FV test. According to the Centers for Disease Control and Prevention (CDCP), between 300,000 and 600,000 people have deep-vein thrombosis, or blood clots; additionally, 5 percent to 8 percent of people have thrombophilia, a condition leading to increased risk of thrombosis. Cepheid’s Xpert HemosIL FII and FB test detects thrombophilia, delivering…