Partnering for Portable & Versatile Point-of-Care Diagnostics

Keralty is an international integrated health group with over 6.9 million patients and 24,450 professionals across Colombia, Peru, Mexico, and the United States. Our organisation combines healthcare delivery, diagnostics, digital health, and research, with extensive experience participating in H2020 and Horizon Europe collaborative projects.

Keralty is well positioned to contribute to HORIZON-HLTH-2027-02-IND-02-two-stage, supporting the clinical validation, real-world testing, and care pathway integration of versatile, portable Point-of-Care (PoC) diagnostic medical devices. Our key capabilities include:

• Clinical Validation & End-User Testing: Capability to execute clinical validation studies and performance evaluation trials across primary care centers, emergency settings, and resource-limited community environments to evaluate PoC sensitivity, specificity, and "sample-to-answer" usability in real clinical workflows.

• Primary Care & Emergency Pathway Integration: Direct integration into outpatient and emergency care pathways across diverse populations (including LMICs), facilitating clinical needs assessments, end-user feedback, and adoption of REASSURED-aligned PoC tools (e.g., distinguishing viral vs. bacterial/fungal infections or rapid NCD detection).

• Laboratory & Microfluidics Benchmarking: A network of over 70 laboratories equipped with advanced diagnostic technologies to perform head-to-head comparative evaluations between PoC devices and gold-standard central laboratory testing methods.

• Digital Connectivity & Mobile Health (mHealth): Experience in linking PoC diagnostic readouts with mobile platforms, cloud systems, and Electronic Health Records (EHR) to support real-time data capture, data privacy, and clinical decision support.

In addition, BioKeralty Research Institute—the R&D&I unit of Keralty—provides specialized support in Health Technology Assessment (HTA), value-based healthcare concepts, IVDR/MDR regulatory strategy alignment, and exploitation planning to accelerate the market readiness and health system adoption of PoC technologies.

Together, Keralty and BioKeralty offer a strong combination of clinical trial infrastructure, primary care access, regulatory expertise, and real-world evaluation capabilities, making us an ideal partner for consortia developing innovative, affordable, and versatile Point-of-Care diagnostic devices under the HORIZON-HLTH-2027-02-IND-02-two-stage call.