StatLab activates new U.S. manufacturing capabilities to secure supply for domestic pathology labs.

Strategic investments reinforce supply chain resilience and streamline U.S. production of essential diagnostic supplies.

StatLab launches new U.S.-based manufacturing capabilities, advancing its multi-year "in-region, for-region" strategy to ensure reliable, scalable production of critical reagents for pathology labs nationwide. The latest milestone—insourcing injection-molded prefill containers—further strengthens StatLab’s position as one of the top U.S. manufacturers of formalin prefills, producing nearly 100 million units annually, while increasing supply chain reliability for labs amid ongoing global uncertainty.

“As one of the market leaders for essential pathology consumables, insourcing key containers for the products we make, including gallon bottles and prefills, empowers us to control quality and protect our customers against external market forces.”

StatLab has a long history of manufacturing StatClick™ formalin prefills, but by becoming the first in its industry to vertically integrate container and lid production in-house, it is increasing control and reducing supply chain risk for this essential product used in operating rooms and labs every day across the U.S. In addition to bringing injection molding for prefill containers in-house, StatLab will also begin blow molding gallon bottles in Q2. Production capacity for cassettes continues to grow as well, with new injection molding cells added at the Arlington facility to meet strong U.S. demand.

“At StatLab, it is in our DNA to invest ahead of the need,” said Sung-Dae Hong, CEO of StatLab. “As one of the market leaders for essential pathology consumables, insourcing key containers for the products we make, including gallon bottles and prefills, empowers us to control quality and protect our customers against external market forces.”

In another proactive move to support customers through challenging market conditions, StatLab has announced it will currently absorb any tariff-related fees associated with products manufactured in its European facilities when selling directly to U.S. laboratories. These products include PiSmart cassette and slide printers, KT microscope slides, and KT coverglass. By leveraging its U.S. and European manufacturing capabilities, StatLab is able to offer consumables for the full pathology workflow protected from tariff impact, empowering domestic customers to focus more on patient care.

“Delivering stability for our customers, especially in times of volatility, is part of the trust we build every day,” continued Hong. “We recognize the importance of predictable pricing and reliable access to the essential supplies labs need for accurate diagnoses.”