Begin with a comprehensive consultation to align your scientific goals with regulatory requirements. Our experts help define the scope of your LDT, including sequencing targets, clinical use, and performance criteria.

Leveraging our state-of-the-art facilities and expertise in genomics, epigenomics, and bioinformatics, we assist in the design and development of your LDT, optimizing for reproducibility, sensitivity, and specificity.

To ensure reliability and relevance in a clinical setting, we conduct thorough analytical validations to assess performance characteristics such as accuracy, precision, and analytical sensitivity and specificity under various conditions.

Performance Evaluation: We assess the test’s analytical sensitivity and specificity, key metrics that determine its clinical effectiveness.

Clinical Sample Testing: We validate the test by applying it to human clinical samples, ensuring it accurately detects the target analyte or condition within the biological variability and complexity of patient samples, confirming its reliability for clinical use.

Navigating the documentation for CLIA certification can be complex and time-consuming. Wasatch Biolabs provides comprehensive support in preparing and organizing all necessary documentation, including standard operating procedures (SOPs), validation records, and quality control procedures.

Our regulatory experts guide you through the process of obtaining CLIA certification for your LDT. From initial application to inspection readiness, we stand with you every step of the way, ensuring that your laboratory meets all federal standards required for clinical testing.

After CLIA certification, Wasatch BioLabs continues to support your operations with ongoing compliance monitoring, proficiency testing, and re-validation services as needed to accommodate assay updates or expanded clinical indications.