Henry Schein, Inc. (HSIC) has secured exclusive U.S. distribution rights for CytoChip’s CitoCBC® system, the first cartridge‑based complete blood count (CBC) platform to receive a Clinical Laboratory Improvement Amendments (CLIA) waiver. The agreement covers ambulatory care settings—including physician offices, urgent‑care centers, and critical‑access hospitals with 25 or fewer beds—while excluding long‑term care and acute‑care facilities.
The CitoCBC® system delivers a full CBC in approximately eight minutes using fluorescent flow cytometry in a single disposable cartridge. FDA 510(k) clearance and the CLIA waiver mean that the test can be performed by personnel with a high‑school diploma, expanding its usability in point‑of‑care environments where laboratory technicians are scarce.
CytoChip’s OneChip platform miniaturizes traditional flow cytometry, enabling rapid, laboratory‑grade testing outside the laboratory. The CLIA waiver is a milestone that opens a new market segment for Henry Schein, which has been pursuing higher‑margin, high‑growth businesses under its BOLD+1 strategic plan. The partnership positions the company to capture a share of the projected $55.98 billion global point‑of‑care diagnostics market, which is expected to grow at a 9.4% CAGR through 2034.
Ty Ford, Vice President and General Manager of Sales for Henry Schein Medical, said the deal “strengthens our commitment to offering healthcare providers products that increase efficiencies while enhancing patient care.” He added that the CitoCBC® system will bring essential lab testing out of the hospital and into the office, providing results during the patient visit.
Wendian Shi, Ph.D., CEO of CytoChip, noted that the partnership “expands the reach of CitoCBC, enabling physicians, urgent‑care staff, and pharmacies to access immediate diagnostic data.” He emphasized that the CLIA waiver “fills a critical gap in CLIA‑waived testing and expands diagnostic accessibility in underserved areas.”
Henry Schein’s Q1 2025 earnings—reported on March 15, 2025—showed non‑GAAP diluted EPS of $1.15, beating the consensus estimate by $0.04. Total revenue of $3.17 billion was flat year‑over‑year, and the company maintained its 2025 guidance of $4.80–$4.94 in non‑GAAP diluted EPS. The new distribution deal is expected to add a high‑margin revenue stream that aligns with the company’s focus on digital capabilities and high‑growth segments.
The agreement’s financial terms are undisclosed, but the exclusive rights and the rapid‑turnaround technology position Henry Schein to cross‑sell the CitoCBC® system alongside its existing specialty and technology solutions, potentially boosting its service‑based revenue mix.
Overall, the partnership marks a significant expansion into the point‑of‑care testing space, offering Henry Schein a foothold in a rapidly growing market and reinforcing its strategic shift toward higher‑margin, high‑growth businesses.
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