The Food and Drug Administration has cleared the MeMed BV® test for distinguishing between bacterial and viral infections.
The MeMed BV test is an immune-based protein signature test that assesses the levels of 3 host proteins (TRAIL, IP-10, and CRP) and assigns a score indicating the likelihood of a bacterial or viral infection. MeMed BV runs on the MeMed Key® platform and provides results within 15 minutes.
The MeMed Key platform utilizes a chemiluminescense technology to analyze various specimen types, including serum, plasma, capillary blood, urine, and nasal specimens. The approval was granted based on data from a multicenter blinded clinical validation study (ClinicalTrials.gov Identifier: NCT04690569) that included over 1000 adults and children.
“For those of us who care for acutely ill children, we have been waiting decades for accurate, rapid diagnostics to confidently guide the care of moderately ill children without a clear focus of infection or recognizable viral illness,” said Rich Bachur, MD, Professor of Pediatrics and Emergency Medicine, Harvard Medical School, and Chief, Division of Emergency Medicine, Boston Children’s Hospital. “This novel test offers promise to help differentiate those children with self-limited viral illness from those with possible bacterial infection, thereby supporting the judicious use of antibiotics.”
- FDA clears first technology to distinguish between bacterial and viral infections using the body’s immune response – the MeMed BV® Test and MeMed Key® platform. News release. MeMed. Accessed September 20, 2021. https://www.globenewswire.com/news-release/2021/09/20/2299432/0/en/FDA-Clears-First-Technology-to-Distinguish-between-Bacterial-and-Viral-Infections-Using-the-Body-s-Immune-Response-The-MeMed-BV-Test-and-MeMed-Key-Platform.html.
- Products: MeMed BV. MeMed. Accessed September 20, 2021. https://www.me-med.com/memed-bv.