Henry Schein inks exclusive U.S. distribution deal for CLIA-waived CBC system

Henry Schein Inc. has entered into an exclusive U.S. distribution agreement with CytoChip Inc. for the CitoCBC system, a cartridge-based Complete Blood Count device that has received U.S. Food and Drug Administration 510(k) clearance and a CLIA Waiver.

The system is designed to expand access to lab-quality blood testing at the point of care. According to the companies, the CitoCBC system is the first cartridge-based CBC system to receive a CLIA Waiver from the FDA, allowing it to be used in settings such as physician offices and urgent care centers without the need for a certified laboratory.

“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,” Ty Ford, vice president and general manager of sales for Henry Schein Medical, said in a statement. “This collaboration strengthens our commitment to offering healthcare providers products and solutions that increase efficiencies while enhancing patient care.”

The CitoCBC system delivers a full CBC in approximately eight minutes and requires minimal staff training. The device achieves lab-quality accuracy by miniaturizing fluorescent flow cytometry technology into a single-use cartridge, allowing it to be used in near-patient clinical settings.

“Partnering with Henry Schein enables us to expand the reach of CitoCBC, assisting health care 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.”

Under the agreement, Henry Schein holds exclusive distribution rights in the United States for ambulatory care settings, including physician offices, urgent care centers, and critical access hospitals with 25 patient beds or fewer. The exclusivity does not extend to long-term care or acute care facilities.

Point-of-care diagnostics continue to move testing closer to patients

The agreement reflects broader momentum in point-of-care diagnostics, as health care systems seek faster results, streamlined workflows, and reduced reliance on centralized laboratories. Advances in microfluidics, biosensors, and miniaturized analytical technologies are enabling complex tests that once required full laboratory infrastructure to be performed in outpatient and retail care settings.

Complete Blood Count testing has been a particular focus of innovation because of its widespread use in diagnosing infections, anemia, inflammatory conditions, and treatment response. Historically, CBC testing required venous blood draws and laboratory analyzers operated by trained technicians. Newer systems increasingly rely on small blood volumes, automated sample handling, and cartridge-based designs that reduce variability and operator error.

Regulatory progress has also played a role. CLIA waivers are increasingly granted to diagnostic tools that demonstrate accuracy comparable to traditional lab testing while maintaining ease of use. This regulatory pathway has encouraged developers to prioritize intuitive interfaces, built-in quality controls, and automated calibration to meet waiver requirements.

The growth of urgent care, retail clinics, and value-based care models has further accelerated demand for near-patient testing. Providers in these settings often need rapid diagnostic information to guide treatment decisions during a single visit, particularly when follow-up may be uncertain. Faster turnaround times can reduce unnecessary referrals, limit empiric prescribing, and improve patient satisfaction.

At the same time, health systems face ongoing staffing shortages and cost pressures, making simplified diagnostic workflows more attractive. Cartridge-based testing platforms that minimize training requirements and maintenance demands align with efforts to improve efficiency while maintaining clinical quality.

As these technologies mature, industry observers expect point-of-care diagnostics to continue expanding beyond basic screening tests into more complex hematology, chemistry, and infectious disease applications, further shifting diagnostic decision-making closer to where patients receive care.