Nationwide consulting · United States
Scientific Expertise.
Regulatory Clarity.
Operational Results.
Nationwide consulting for clinical laboratories, molecular diagnostics and life sciences—spanning assay development, validation, regulatory readiness, MolDx strategy, laboratory operations and clinical evidence.
Led by
Priestly Penda
Molecular diagnostics & clinical laboratory leader · M.S., Microbiology and Cell Science, University of Florida
About Priestly Consulting
Bridging scientific innovation and real-world implementation.
Our work spans complex molecular and clinical laboratory testing, including multiplex PCR, next-generation sequencing, infectious disease diagnostics, pharmacogenomics and precision medicine. We help clients design defensible validation studies, strengthen quality systems, prepare technical and reimbursement submissions, optimize workflows and communicate evidence clearly to reviewers, partners and healthcare stakeholders.
Led by a scientific laboratory professional with experience in chief scientific leadership, laboratory operations and frontline clinical laboratory practice, Priestly Consulting brings an integrated perspective across science, compliance, evidence and execution.
What we do
Services built for laboratories and diagnostic innovators.
From initial assay concept through validation, regulatory or payer review, and sustainable laboratory operations.
Specialized areas
Depth where complex testing needs it most.
Molecular infectious disease
Urinary tract infection, wound and respiratory testing; multiplex pathogen and antimicrobial resistance detection; individual and grouped assay targets.
Regulatory and payer evidence
MolDx technical assessment responses, validation gap remediation, DEX Z-Code strategy, AMA PLA descriptions, and alignment of analytical validity, clinical validity and clinical utility.
Laboratory assay platforms
Real-time PCR, high-complexity molecular workflows, NGS and related clinical diagnostic technologies.
Scientific reporting
Positive/negative result conventions, grouped gene interpretation, Ct/Cq decision rules, genotype-versus-phenotype limitations, report wording and clinician-facing interpretive notes.
Clinical and research documentation
Study protocols, validation reports, comparator workbooks, statistical performance summaries, clinical study reports and publication-support materials.
Laboratory quality and execution
SOPs, CLIA/CAP readiness, quality control, training, inspection support, workflow redesign and multi-site operational planning.
Industries served
Who we work with
Independent and reference laboratories, hospital and health-system laboratories, diagnostics developers, biotech and medtech companies, research organizations and laboratory investors.
How we work
A clear path from question to documented result.
Discover
A focused consultation to understand your test, intended use, timeline and the decision or review you are preparing for.
Assess
We review existing data, documents and workflows to identify gaps, risks and priorities.
Plan
A clear scope, deliverables and milestones — validation plans, response strategies or implementation roadmaps.
Execute & document
Hands-on support through studies, analysis and writing, producing documentation built for reviewers and inspectors.
Ideal engagements
Is this where you are right now?
These are the situations where we typically add the most value.
- A laboratory preparing an LDT for clinical launch and needing a complete validation and reporting framework.
- A diagnostic developer responding to MolDx technical assessment questions or preparing a DEX Z-Code submission.
- A molecular laboratory seeking a defensible PLA description and reimbursement evidence strategy.
- A laboratory expanding from singleplex to multiplex PCR, implementing a new instrument, or bridging assay versions.
- A healthcare diagnostics organization needing a clinical evidence package, study design or manuscript support.
- A laboratory seeking inspection readiness, improved SOPs, turnaround time or operational efficiency.
Insights
Practical knowledge for laboratory leaders.
FAQ
Common questions
Ready to move your test forward?
Book a consultation to talk through your assay, validation, submission or operational goals. Serving clients nationwide.