LuminoDx has announced that its San Diego laboratory has been awarded Clinical Laboratory Improvement Amendments (CLIA) certification. This certification, granted by the Centers for Medicare and Medicaid Services (CMS), permits clinical laboratories to process and analyse human samples for diagnostic purposes.

The certification allows LuminoDx to commence testing patient samples with its first liver health-focused diagnostic, the Factor V assay. The laboratory also plans to expand its services to include a test designed to predict liver rejection following transplantation.

By clinically validating Laboratory Developed Tests (LDTs), the company aims to broaden its testing portfolio and support the development of therapeutic solutions for the biotech and pharmaceutical sectors. These validated, indication-specific tests will enhance clinical and research capabilities.

LuminoDx’s founders, who have extensive expertise in assay development and sample analysis for both clinical and non-clinical studies, are positioned to deliver high-quality diagnostic solutions.

Their capabilities span diverse platforms, including nucleic acid analysis, proteomics, and metabolomics. With the CLIA certification, LuminoDx’s GLP-compliant laboratory is now equipped to process patient samples and provide essential data to aid in clinical decision-making.



Source: prnewswire.com

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