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FDA Grants Breakthrough Status to Blood Test That Tells Bacteria from Virus
The FDA has granted Breakthrough Device designation to MeMed BV Flex, a blood test that rapidly distinguishes bacterial from viral infections using immune-response protein signatures, potentially reducing the antibiotic overprescribing that fuels antimicrobial resistance.
Key Takeaways
- MeMed BV Flex measures a three-protein immune signature (TRAIL, IP-10, CRP) that distinguishes bacterial from viral infection
- FDA Breakthrough Device designation commits the agency to expedited interactive review and senior staff involvement
- Reducing inappropriate antibiotic prescriptions directly counters antimicrobial resistance, which causes 1.27 million deaths per year
- The test targets the majority of primary care antibiotic prescriptions, which are predominantly for viral respiratory infections
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DT Editorial AI··via medicalxpress.com