FDA Clears Pioneering MeMed BV Test Direct From Whole Blood Allowing Faster Time To Result And Broader Patient Access When Distinguishing Bacterial From Viral Infections
- Opens up testing to decentralized settings including urgent care centers which see 100 million patient visits for potential infections in the US annually
- Significant milestone towards making bacterial versus viral infection testing standard of care
- Measurement of multiple low concentration proteins quickly in whole blood is notable new technological advance
TIRAT CARMEL, Israel; BOSTON, MA, 19 July, 2023 – MeMed, a leader in the emerging field of advanced host response technologies, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for use of the MeMed BV® test on whole blood samples on the point-of-need MeMed Key® analyzer to help healthcare providers distinguish between bacterial and viral infections in 15 minutes.
Through newly developed technology, MeMed BV on whole blood can accurately and quickly measure multiple proteins present in low concentrations from a small volume of whole blood. An earlier version of the test conducted on serum (cleared by the FDA in 2021) is being rolled out successfully in medical centers on the MeMed Key platform as well as on high throughput analyzers via partnerships with leading diagnostic companies.
This new version of MeMed BV retains the exceptional performance of its serum counterpart but eliminates the need for clotting and spinning, enabling MeMed to approach decentralized settings in the US, such as urgent care centers, where minimal handling and maintenance are essential.
Eran Eden, CEO of MeMed: “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. The basis of physician prescription of unnecessary antibiotics is diagnostic uncertainty – is the patient presenting with a bacterial or a viral infection? The two are often clinically indistinguishable. 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.”
Dr Sridevi Devaraj, Medical Director of Clinical Chemistry and Point of Care Testing at Texas Children’s Hospital, said: “This enhancement to the MeMed BV test is an exciting development. The fact that the test can now be carried out directly on whole blood means minimal handling and a reduced burden in the clinical setting alongside a bacterial versus viral decision with shorter patient waiting times. I anticipate that this will enhance both patient and physician satisfaction.”
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