Partnership Expands Access to FDA-Cleared CitoCBC System Across the U.S.

Henry Schein, Inc. has entered into a new exclusive distribution agreement with CytoChip Inc. for its flagship product, the CitoCBC system, a U.S. Food and Drug Administration (FDA) 510(k)-cleared device. Available now to Henry Schein customers in the United States, the CitoCBC system is the first cartridge-based Complete Blood Count system to receive a CLIA Waiver, helping expand access to accurate, lab-quality testing at the point of care.

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The CitoCBC system is the first cartridge-based Complete Blood Count (CBC) system to receive a CLIA Waiver from FDA, helping expand access to accurate, lab-quality testing in urgent care centers and physician offices.

“We are pleased to join with CytoChip to provide the CitoCBC system to our customers, helping to bring essential lab testing out of the hospital and into the office, with results provided to the patient during their visit,” said Ty Ford, Vice President and General Manager of Sales for Henry Schein Medical. “This collaboration strengthens our commitment to offering healthcare providers products and solutions that increase efficiencies while enhancing patient care.”

The CitoCBC system delivers full CBC results in approximately eight minutes, requires minimal staff training, and provides lab-quality accuracy by miniaturizing advanced fluorescent flow cytometry technology onto a cartridge for use in near-patient settings.

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“Partnering with Henry Schein enables us to expand the reach of CitoCBC, assisting healthcare providers in settings such as physician offices, urgent care centers, and pharmacies to access immediate diagnostic data,” said Wendian Shi, PhD, Chief Executive Officer of CytoChip. “Together, we can support more informed diagnostic decisions and improve patients’ access to timely care.”

Henry Schein’s exclusivity in the United States includes ambulatory care settings such as physician offices, urgent care centers, as well as critical access hospitals with 25 patient beds or fewer. The exclusivity does not include long-term care or acute care facilities.

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Source- businesswire