The US Food and Drug Administration (FDA) has granted a 510(k) clearance to Israeli medtech company MeMed for the use of its BV test on whole blood samples on the point-of-need MeMed Key analyser.
In a span of 15 minutes, healthcare providers will be able to differentiate between bacterial and viral infections through the use of this test.
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From a small volume of whole blood, MeMed BV can precisely measure several proteins found even in low concentrations.
The company stated that a previous version of the test, which was carried out on serum that had received clearance from the FDA in 2021, is being launched successfully in medical centres on the MeMed Key platform besides on high throughput analysers through partnerships with diagnostic companies.
While retaining the performance of its serum counterpart, the new version of the MeMed BV test removes the requirement for clotting and spinning.
This facility allows MeMed to approach decentralised settings in the country, such as urgent care centres, where maintenance and minimal handling are important aspects.
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By GlobalDataMeMed CEO Eran Eden said: “The FDA clearance of MeMed BV on whole blood is a significant milestone in our journey to make bacterial versus viral infection testing a standard of care.
“This enhancement to enable testing on whole blood allows for even easier use, faster results and maintains the same level of performance, leading to improved patient care now being available across broader settings in the care continuum.
“By providing a rapid, reliable solution for differentiating between bacterial and viral infections, this test can help reduce the risk of unnecessary antibiotic prescriptions, one of the key drivers of antibiotic resistance.”
