BACKGROUND:

The standard hospital CBC is based on an indirect light scatter/impedance measuring instrument; no imaging or internal validations. Many samples meet instrument flagging criteria and require microscopic review of a stained whole blood smear¹. Although the diagnostic range is limited, a light scatter CBC is fast for bulk screening, and can be CLIA Waived. NoLabDx’s founder is one of the inventors of the process, and an inventor of one of the current hospital grade automated digital slide scanners – patented.

All-in-One Robotic Laboratory Automation:

The NoLabDx platform integrates advanced robotic automation, high-resolution oil-immersion microscopy, and embedded computing with AI-guidance to provide a versatile, low-cost, all-in-one diagnostic solution. Unlike conventional laboratory instruments designed for specific tests, The Rascal® is engineered as a multi-purpose platform that automatically adapts its processing sequence to the requirements of each disposable diagnostic cartridge. A QR code identifies the cartridge and provides the instructions needed to execute its specific diagnostic protocol.

By combining established laboratory methodologies with programmable robotics and cartridge-specific processing, NoLabDx brings complex diagnostic procedures directly to the Point-of-Need (PON). The demonstrated CBC workflow produces cellular images and analytical results in minutes, while the platform architecture supports expansion to additional diagnostic applications through specialized cartridges and software protocols.

Our working prototype demonstrates this approach by fully automating the conventional manual wedge-smear Complete Blood Count (CBC) workflow, using the same fundamental laboratory methods employed in hospitals. The system robotically performs sample preparation, slide handling, smear formation, fixation, staining, drying, and high-resolution oil-immersion microscopy. Each low-cost disposable cartridge contains the required substrates, reagents, stains, immersion oil, and other consumables necessary to complete the diagnostic procedure, eliminating the need for separate laboratory preparation or operator skill.

NoLabDx’s multi-purpose platform has demonstrated the automated implementation of the complete classic manual whole blood wedge smear CBC to prospective partners (see Applications – WBC images: 50x 0.9 NA oil). In our next round of funding we move to preclinical trial validation and AI enhancements.

PROTOTYPE STATUS & ENGINEERING OBJECTIVES:

Demonstrated: Robotic automation of conventional whole blood wedge smear preparation and digital microscopy
Engineering Objectives: Design for low cost manufacturing, in-house validation based on FDA predicates
Next phase: Third-party preclinical validation, upgrade AI and third-party validations, baseline CLIA