CytoChip receives FDA clearance and first CLIA Waiver for CitoCBC
The CLIA-waived CitoCBC expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics.
CytoChip announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and a CLIA Waiver for its CitoCBC, making it the first cartridge-based CBC test to achieve this milestone. A recent study published in Nature by researchers from Harvard Medical School at Massachusetts General Hospital highlights the value of personalized CBC testing for the early intervention of common diseases.