Testing Services

• Accuracy / Precision (Repeatability, Reproducibility)
• Linearity & Range
• Limit of Detection (LOD) / Limit of Quantitation (LOQ)
• Analytical Specificity (e.g., cross-reactivity, interference)
• Stability Testing (sample, reagent, shelf-life)
• Carryover / Hook Effect (for assays)
• Biocompatibility (if body contact) (Per ISO 10993)
• Electrical & EMC Testing (if electronic)
• Software Validation (if software-driven)
• Sterility & Shelf-Life (if sterile device)
• Mechanical Testing (if applicable)
• Human Factors / Usability (if user interaction impacts safety) 

• Diagnostic Accuracy Study
• Comparator/Reference Method Study
• Prospective Clinical Study
• Retrospective Chart Review
• Point-of-Care (POC) Usability Study
• Lay-User Study (for OTC/home-use devices)
• Multi-center Clinical Trial
• Human Factors Validation Study
• Clinical Performance Evaluation (for IVDs)
• Post-market Clinical Follow-up Study (rarely for 510(k))
• Pivotal Clinical Study (if needed for novel features)
• Real-world Evidence Study (if used as supporting data)
• Bridging Study (linking new device to previously approved version)
• Simulated Use Study (especially for usability testing)

Core Laboratory Services:

• Sample Collection, Processing & Storage
• Clinical Chemistry Testing
• Hematology & Coagulation Testing
• Microbiology & Infectious Disease Testing
• Molecular Diagnostics (PCR, NGS, etc.)
• Immunology & Serology Assays
• Biomarker Analysis
• Pharmacokinetics(PK) & Pharmacodynamics(PD) Studies

Specialized Testing Services:

• Genomic & Genetic Testing
• Proteomics & Metabolomics
• Flow Cytometry
• Immunohistochemistry (IHC)
• Cell-based Assays
• Cytogenetics & FISH
• Tissue Banking & Histopathology

Regulatory & Quality Support:

• Method Validation & Verification (CLIA, CAP, GLP, GCP)
• Data Management & Biostatistics
• Regulatory Documentation (e.g., 510(k), IDE, IND support)
• Quality Assurance /QC Monitoring

Apexx Testing partners with laboratories and experts to design Biosafety Level 3 (BSL3) chamber test protocols for testing all types of devices. We will help you navigate the challenging scientific community to get the proper testing with the right laboratory.

Apexx Testing partners with laboratories and experts who specialize in high-precision cell isolation services, offering magnetic bead separation, flow cytometry sorting, and microfluidic techniques. We deliver high-purity, viable cell populations for research, diagnostics, and cell therapy, with expertise supporting both preclinical and clinical applications.

Apexx Testing partners with laboratories to help design chamber test protocols that simulate real-world applications. With involvement in hundreds of successful device efficacy tests against aerosol & surface pathogens, we possess the experience and expertise to help you obtain the data you need.