Laboratory Assay Validation & Technical Support

Pinnacle Biolabs delivers comprehensive assay validation, workflow optimization, and technical support across multiple diagnostic platforms. Our team combines deep scientific expertise with practical laboratory experience to help practices and laboratories build efficient, compliant, and scalable testing programs.

Multiplatform Assay Validation

We support validation, verification, and optimization across a wide range of systems, including:

• Molecular Diagnostics: RT-PCR, ddPCR, and  Next-Generation Sequencing (NGS)
• ImmunoAssay Platforms
• Clinical Chemistry Systems
• Microbiology Systems for infectious disease  applications
  (respiratory, bloodborne, gastrointestinal, dermatological, uro-gynecological)

Regulatory & Compliance Support

Our team provides comprehensive guidance to help laboratories meet regulatory and documentation standards. Support includes: 

• LDT development and FDA-aligned  documentation
• Validation and verification study  design
• CLIA-aligned regulatory readiness
• Method development and  performance monitoring
• Guidance on reporting practices  and clinical utility

Clinical Application Expertise

Our technical and scientific team supports multiple diagnostic specialties, including:

• Pharmacogenomics (PGX)
• Cancergenomics (CGX)
• Infectious disease panels
• Autoimmune screening
• Toxicology
• Custom assay development and validation  

Workflow & Operational Optimization

Our operational support strengthens the efficiency and reliability of laboratory workflows:

• Workflow mapping and optimization
• Ordering pathways integrated with clinical practice
• Sample collection and logistics planning
• Requisition and consent form  design
• Documentation packets for staff  and providers

Technical Staffing & Onboarding

We offer technical support that includes:

• Assistance with hiring highly  skilled technical personnel
• Staff onboarding for new testing  platforms
• Training for order handling, sample processing, and result interpretation
• Ongoing consultative support for complex cases and system troubleshooting

Why Pinnacle Biolabs

Our validation and technical support services are built for practicality, compliance, and long-term sustainability. We help laboratories and providers adopt advanced diagnostic systems without disrupting core operations—ensuring high-quality, clinically meaningful results and operational confidence.