US approves MeMed test to distinguish bacterial from viral infections - Verdict Medical Devices - Medical Device Network
The US Food and Drug Administration (FDA) has approved a test developed by Israeli medtech firm MeMed that can rapidly determine whether an infection has been caused by a bacteria or a virus. The MeMed BV test, which was developed by MeMed using a $30m grant from the EU and US Department of Defense, does not directly detect the cause of an infection. Instead, it analyses three host response proteins – TRAIL, IP-10, and CRP – that show up in a patient's blood at very different levels depending on whether the immune system is fighting off a virus or bacteria. The test, which has received 501(k) clearance, delivers results in 15 minutes. The clearance was based on a multi-centre blinded clinical validation study enrolling over 1,000 childre...