LuminoDx is pleased to announce that its San Diego laboratory has recently received Clinical Laboratory Improvement Amendments (CLIA) certification.
CLIA certification, issued by the Centers for Medicare and Medicaid Services (CMS), is required for clinical laboratories to accept and test human samples for diagnostic purposes.
“This certification allows us to begin testing patient samples with our first liver health-related test, the Factor V assay,” said Yipeng Wang, co-founder and CEO of LuminoDx. “In the near future, we will also add a test to our CLIA menu that is predictive of liver rejection post-transplant. Having the ability to clinically validate Laboratory Developed Tests (LDTs) enables us to expand our portfolio and support biotech and pharmaceutical companies in developing therapeutic solutions with validated, indication-specific tests.”
LuminoDx’s scientific founders, Gordon Vansant and Yipeng Wang, bring extensive technical and scientific expertise across a wide range of platforms. This includes developing assays and testing samples from both non-clinical and clinical studies to support therapeutic drug development, such as the analysis of nucleic acids, proteomics, and metabolomics. “Now, with CLIA validation of our GLP-compliant laboratory, we are equipped to analyze patient samples across multiple platforms and provide critical results to support patient decision-making,” said Gordon Vansant, CBO and co-founder of LuminoDx.
