CLIA Biomarker & Companion Diagnostics
Translating Research Signatures into Certified Clinical Assays
Yatiri Bio's B2B CLIA Biomarker & Companion Diagnostics Service develops and validates clinical-grade assays to qualify patient cohorts for oncology trials. Following the acquisition of NGeneBioAI, Inc. in August 2025, we integrate certified CLIA and CAP laboratory facilities directly into our translational pipeline at Nancy Ridge Dr, San Diego.
Crossing the Translational Preclinical Gap
Preclinical discovery proteomics yields promising predictive signatures, but these signatures cannot be used to select patient cohorts in registrational clinical trials unless they are run inside a certified, compliant environment.
Without a clear path to clinical validation, companion diagnostics (CDx) development stall. To resolve this bottleneck, Yatiri Bio acquired NGeneBioAI, Inc. on August 5, 2025. This integrated Bertis-derived plasma-proteomics systems and a fully staffed, certified wet-lab infrastructure.
We transition biomarkers discovered on our high-resolution research platforms into analytical tests (such as targeted MRM/PRM mass-spec assays, multiplex ELISA, or immunohistochemistry - IHC) validated under strict Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) guidelines.
Assay Validation & Regulatory Capabilities
Our companion diagnostics team supports all phases of B2B clinical trial enablement:
- Analytical Validation: Robust quantification of assay limits (LOD/LOQ), linearity, precision, and reproducibility across clinical sample matrices.
- Targeted MRM/PRM Development: Developing targeted Multiple Reaction Monitoring (MRM) mass-spectrometry assays for clinical plasma or tissue specimens, bypassing antibody limitations.
- Companion Diagnostic (CDx) Scoping: Aligning biomarker assays with regulatory filing requirements (IDE, PMA, 510k) in partnership with biopharma sponsors.
CLIA Biomarker Buyer Questions
When does a discovery signature need CLIA/CAP validation?
Use CLIA/CAP validation when a preclinical or translational marker set needs to qualify clinical trial cohorts or support companion diagnostic development.
What assay formats are supported?
Yatiri Bio can translate protein signatures into targeted mass spectrometry, multiplex immunoassays, or IHC-style workflows depending on study needs.
Request Project Quote
Clinical assay validation campaigns require strict regulatory planning. Scopes are developed around study protocols and sample volumes.