Immunoassay services

Biocult develops and optimizes IVD assays by supporting the full lifecycle of diagnostic test development, from early design and feasibility through analytical validation and transfer to manufacturing. The company focuses on immunoassay and point-of-care technologies, combining technical expertise with ISO 13485-compliant quality systems and strong regulatory guidance for global market approval.

Biocult supports manufacturers with IVDR performance evaluation studies that generate the scientific, analytical, and clinical evidence required for EU market approval of IVDs. The company designs and executes structured studies, including clinical and analytical testing, to demonstrate device performance in line with IVDR requirements and Notified Body expectations. With deep regulatory expertise and ISO 13485-compliant processes, they help ensure reliable data and smooth preparation of the Performance Evaluation Report (PER).

Biocult develops multiplex microarray assays that enable the simultaneous measurement of multiple biomarkers in a single, highly efficient test. These assays are designed for applications such as disease research, biomarker screening, and companion diagnostics, helping generate richer data from minimal sample volumes. Using automated, high-precision microarray technology and ISO 13485-compliant processes, the company delivers scalable, reliable, and regulatory-ready IVD solutions.

Biocult develops point-of-care (POC) diagnostic assays that enable fast, reliable testing closer to the patient, supporting earlier clinical decisions. The company designs and optimizes rapid immunoassay-based solutions that combine high performance with user-friendly formats for decentralized healthcare settings. With ISO 13485-compliant development processes and strong regulatory expertise, they help translate laboratory-grade assays into robust, market-ready POC diagnostic products.

Biocult provides verification and validation services to confirm that IVD assays meet predefined performance requirements before market release. This includes systematic testing of analytical and clinical performance to ensure accuracy, reliability, and regulatory compliance. With ISO 13485-compliant quality systems, they support manufacturers in generating robust evidence needed for IVDR and global regulatory approval.