Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician offices in the U.S. lack the necessary infrastructure to perform on-site CBC testing, often resulting in delayed results and missed diagnostic opportunities during patient consultations. Now, a new cartridge-based CBC test is expanding access to quick results in physician offices, pharmacies, and home care settings, making data-driven diagnostics more accessible.

CytoChip’s (Irvine, CA, USA) CitoCBC is a cartridge-based CBC system that allows healthcare professionals to quickly perform accurate CBC testing not only in hospitals but also in physician offices, pharmacies, nursing homes, and other places where CBC testing was previously unavailable. CitoCBC is designed to offer both ease of use and high performance. The self-contained cartridge simplifies the testing process, providing a comprehensive 5-part differential CBC with a turnaround time of just eight minutes. On-screen, step-by-step instructions guide users through the process, even if they have no laboratory experience. The system includes advanced features, such as Optical Fluorescent Platelet (OFP) detection, which surpasses the capabilities of many traditional lab analyzers. The analyzer also conducts periodic self-checks to ensure its functionality. Test results can be displayed on-screen, printed out, or transmitted via connection to a laboratory information system (LIS). In comparisons to state-of-the-art CBC solutions used in hospitals and clinical labs, the performance of CitoCBC has proven to be substantially equivalent. The CBC counts produced meet the rigorous CLIA 2024 Proficient Testing standards for hematology.

Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and a CLIA Waiver for CitoCBC, making it the first cartridge-based CBC test to achieve this milestone. This breakthrough significantly increases access to CBC testing in decentralized healthcare environments like physician offices, pharmacies, and home care settings. The CLIA Waiver eliminates testing barriers, allowing for fast, reliable CBC results in a compact device, which ultimately improves patient care and supports better clinical decision-making. With FDA clearance and a CLIA waiver, CitoCBC ensures accuracy and reliability, allowing non-laboratory personnel to operate the system effectively. Overall, CitoCBC provides state-of-the-art testing with a small footprint, requiring minimal staff training and lower capital investment. The product will first launch in the United States and later expand to select European countries upon obtaining the CE Marking.

"Achieving CLIA Waiver for a CBC test is a major step forward in improving access to diagnostics at the point of care," said Dr. Wendian Shi, CEO of CytoChip. "This milestone not only fills a critical gap among CLIA Waived testing but also expands diagnostic accessibility in underserved areas."

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