Clinical Laboratory Consulting & Molecular Diagnostics

Helping clinical laboratories and biotech companies develop, validate, document, and improve molecular diagnostic testing workflows.
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About

Biotech Insight Solutions is the consulting practice of David Cheishvili, PhD, a molecular diagnostics and epigenetics scientist with over 25 years of experience in molecular biology, cancer biomarkers, clinical NGS, bioinformatics, assay development, and translational diagnostics.

I help clinical laboratories and biotech companies develop, validate, document, and improve molecular diagnostic testing workflows, including targeted NGS, DNA methylation assays, LDT development, clinical validation, and bioinformatics review.

My work combines wet-lab experience, bioinformatics, CAP/CLIA documentation, SOPs, quality systems, HIPAA/PHI policy support, inspection readiness, and biomarker development to support practical, compliant, and scientifically sound molecular testing.

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Need Practical Molecular Diagnostics Support?

I help clinical laboratories and biotech teams develop, validate, document, and improve molecular diagnostic workflows.

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CAP/CLIA documentation
Compliance-ready workflows
SOPs, quality systems, proficiency testing, and inspection readiness.
Molecular diagnostics & LDTs
Validation planning
Analytical validation, troubleshooting, and documentation.
Clinical NGS & bioinformatics
Data-to-result review
Analytical validation, troubleshooting, and documentation.

Services

I provide focused consulting support for clinical laboratories and biotech teams working with molecular diagnostics, LDTs, clinical NGS, and biomarker-based testing.

Clinical Laboratory Compliance & Accreditation Support

CAP/CLIA documentation, SOP preparation, quality systems, proficiency testing, inspection readiness, and laboratory compliance support.

Molecular Diagnostics & LDT Validation

Assay development, LDT validation planning, analytical validation strategy, performance review, troubleshooting, and documentation.

Clinical NGS & Bioinformatics Review

Targeted NGS, DNA methylation analysis, sequencing QC, pipeline review, bioinformatics review, and molecular result interpretation.

For project-specific consulting, documentation review, assay validation support, or molecular diagnostics troubleshooting, please request a consultation.

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Need Clinical Lab
Consulting Support?


If your laboratory or biotech team needs support with molecular diagnostics, assay validation, CAP/CLIA documentation, SOPs, quality systems, clinical NGS, bioinformatics review, or inspection readiness, I’d be happy to discuss how I can help.
REQUEST A CONSULTATION
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