Have questions? reach out
Have questions? reach out
At Wasatch BioLabs, we simplify the process with native-read sequencing technologies and a Clinical Laboratory Improvement Amendments (CLIA)-certified environment, supporting every stage of development from biomarker discovery to clinical implementation.
By eliminating bisulfite-induced DNA damage, amplification biases, and location-based batch effects, our direct sequencing services overcome the key challenges of legacy technologies, providing a more reliable foundation for assay development. Combined with regulatory-optimized validation pipelines, we offer a streamlined path to clinical and commercial success.
[ Biomarker Discovery ]
[ Targeted Sequencing ]
[ Deployment ]
Start with a comprehensive consultation to align your goals with regulatory requirements. Our experts help define the scope of your test, including sequencing targets, clinical use, and performance criteria.
Leverage our team’s expertise in genomics, epigenomics, and bioinformatics to develop of your clinical test, optimizing for reproducibility, sensitivity, and specificity.
We perform analytical validations to ensure reliability in clinical settings, evaluating accuracy, precision, sensitivity, and specificity.
Performance Evaluation: Assess analytical metrics critical for clinical effectiveness.
Clinical Sample Testing: Validate the test on human samples to confirm real-world accuracy and reliability.
Simplify CLIA certification with our end-to-end documentation support, including SOPs, validation records, and quality control reports.
Our regulatory team guides you through the CLIA certification process, from application to inspection readiness, ensuring compliance with federal and state standards.
After certification, we provide ongoing support with compliance monitoring, proficiency testing, and re-validation services for assay updates or expanded clinical use.
Wasatch BioLabs empowers researchers to translate innovation into clinical impact. With expert guidance, regulatory support, and a CLIA-certified environment, we streamline the path from biomarker discovery to validated clinical assays—ensuring precision, compliance, and real-world applicability.
Timelines vary based on assay complexity and regulatory scope, but the general phases include:
Step 1: Consultation & Planning
Step 2: Assay Development & Optimization
Step 3: Analytical Validation & Clinical Testing
WBL accelerates timelines through streamlined native-read workflows that bypass legacy limitations like bisulfite damage and amplification bias.
WBL adheres to stringent quality control metrics during every stage of clinical assay development. Our CLIA-certified environment ensures accuracy, precision, sensitivity, and specificity are met. They also offer routine proficiency testing, ongoing monitoring, and assay re-validation to maintain compliance.
Yes. WBL specializes in custom clinical assay development, tailoring every assay to the study’s therapeutic area, target biomarkers, and desired clinical endpoints. Our team collaborates closely with clients to develop precision assays suited for both research and regulated clinical use.
To initiate a project, simply contact Wasatch BioLabs through our website or via email. Our experts will schedule a consultation to discuss your goals, define assay requirements, and guide you through the design, development, and validation process under CLIA standards.
