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Knowledge for laboratory and diagnostics leaders.

Practical, sourced articles on validation, evidence, regulatory readiness, reimbursement and laboratory operations.

All Validation MolDx & Reimbursement Regulatory & Quality Molecular Diagnostics Laboratory Operations FAQs

Clinical laboratory bench equipped with next-generation sequencing and PCR platforms for molecular diagnostic testing

What Is a Molecular Diagnostic Test? Methods, Uses & Launch Guide

Discover what a molecular diagnostic test is, compare core methods like qPCR and NGS, and explore the 5-stage roadmap for launching an LDT in a CLIA laboratory.

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High-complexity molecular diagnostics laboratory equipped for pharmacogenomic testing and genotyping assay validation

Molecular Diagnostics· 12 min read

Pharmacogenomic Testing: Assay Design, Validation & MolDX Guide

A technical guide to pharmacogenomic (PGx) testing, covering AMP Tier 1 allele selection, CYP2D6 CNV resolution, CPIC phenotype translation, and MolDX reimbursement requirements.

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Modern clinical laboratory setting with diagnostic instruments, representing the CLIA certification workflow

Regulatory & Quality· 14 min read

What Is CLIA? CLIA Certification, Types, and CMS-116 Guide

Learn what CLIA is, explore the five CLIA certificate types, and follow the step-by-step CMS-116 application process to establish a certified clinical laboratory.

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Clinical molecular laboratory setup demonstrating limit of detection testing for PCR assays

Molecular Diagnostics· 11 min read

Limit of Detection (LoD) in Molecular PCR Assays: Calculation Guide

A technical guide to calculating Limit of Detection (LoD) and Limit of Quantitation (LoQ) in molecular and PCR assays under CLSI EP17-A2 and CLIA standards.

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Clinical diagnostic test validation showing sensitivity vs specificity analysis on a laboratory monitor

Regulatory & Quality· 11 min read

Sensitivity vs Specificity in Clinical Diagnostic Tests

Master sensitivity vs specificity formulas, 2x2 contingency analysis, Bayesian prevalence shifts, and regulatory distinctions separating clinical accuracy from PPA/NPA agreement.

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High-complexity molecular diagnostic laboratory highlighting CLIA vs CAP accreditation difference and test validation workflows

FAQs· 10 min read

CLIA vs CAP Accreditation Difference, LDTs, & Validation FAQ

Get answers to critical clinical laboratory questions covering LDT regulatory status, CLIA vs. CAP requirements, verification vs. validation, and multiplex AMR testing.

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Clinical laboratory scientist reviewing molecular assay data for an AMA PLA code application under navy and teal ambient lighting

MolDx & Reimbursement· 12 min read

AMA PLA Code Application: Eligibility, Descriptors & CLFS Pricing

A definitive guide to AMA CPT PLA code applications, descriptor architecture, quarterly submission cycles, and navigating Medicare CLFS crosswalk versus gapfill pricing.

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Clinical molecular diagnostics laboratory illustrating the MolDX technical assessment process

MolDx & Reimbursement· 10 min read

MolDX Technical Assessment Process: DEX, Z-Codes & Dossiers

Navigate the MolDX technical assessment process: understand DEX Z-Code registration, analytical and clinical evidentiary requirements, and avoid costly review stalls.

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Molecular diagnostics laboratory bench setup illustrating PPA and NPA calculation molecular validation

Validation· 11 min read

PPA and NPA Calculation in Molecular Validation: A Guide

Learn how to calculate PPA and NPA, compute Wilson score 95% confidence intervals, avoid discordant resolution bias, and report target-level metrics in molecular diagnostic validations.

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Clinical diagnostic laboratory executing CLIA LDT analytical validation for molecular testing platforms

Validation· 10 min read

CLIA LDT Analytical Validation: Molecular Assay Guide

A step-by-step guide to CLIA LDT analytical validation under 42 CFR § 493.1253(b)(2) for molecular assays, covering accuracy, precision, LoD, specificity, and current FDA regulatory oversight.

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