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.
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.
