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Our Story
Molecular answers, engineered under one roof.
Prime Path Lab is a molecular diagnostics laboratory in Denver, Colorado. We design the assay, validate it on our own instruments, sequence the specimen, run the bioinformatics, and sign the report — the entire chain, in one building, under one CLIA certificate. Nothing is sent out. Nothing is outsourced. The science that produces your patient’s result never leaves our hands.
Why we built this
A laboratory is only as trustworthy as the shortest distance between the specimen and the signature.
The diagnostics industry scaled by adding distance. A laboratory wins an account, accepts more volume than its bench can absorb, and routes the overflow to a reference partner in another state. The requisition still carries the original name; the report still carries the original letterhead. Somewhere in the middle, accountability quietly evaporates — and when a physician calls to ask why a result looks wrong, the laboratory that signed it often cannot answer, because it never ran the test.
Prime Path was engineered to make that failure impossible. We hold one CLIA certificate for one physical laboratory, and every assay we offer is developed, validated, performed, interpreted, and reported inside it. That is a deliberately smaller business than it could be. It is also a laboratory a physician can actually stand behind, because the person who validated the method is the person who answers the phone.
Our Vision
To make the curated molecular test the standard of care — and to build our own.
We are working toward a portfolio of proprietary, Prime-Path-developed assays: targeted panels engineered around real clinical questions rather than maximal gene counts, and refined as the evidence moves. That roadmap includes pursuing dedicated Proprietary Laboratory Analyses (PLA) codes through the AMA for the laboratory-developed tests we build — the same path that distinguishes an assay a laboratory invented from a commodity anyone can run.
Our Mission
Accurate, reimbursement-aware molecular testing from a single accountable laboratory.
Every result we release is validated in-house, interpreted under a named director, built against payer coverage policy so a clean claim follows a correct answer, and reachable — when a clinician calls with a question, it goes to the scientist who ran the specimen, not to a queue.
The Science
We develop our own tests. We do not resell someone else’s.
Nearly everything Prime Path runs is a laboratory-developed test — an assay we designed, optimised, and validated on our own platforms rather than a kit taken off a shelf. Under 42 CFR 493.1253, that obligation is ours to discharge: accuracy, precision, analytical sensitivity and specificity, reportable range and reference intervals, established and documented on the instrument and by the staff that will run it. A validation performed by a vendor in another state is a starting point, not a result.
The panels themselves are proprietary curations. Our genomic assays are built gene by gene against gene–disease validity evidence, and carved into sub-panels — cardiomyopathy separated from channelopathy, epilepsy separated from neuropathy — so a clinician orders the question their patient actually presents with. Off-the-shelf breadth is easy to advertise and expensive for the patient; curated depth is harder to build and worth more at the point of care.
In-house bioinformatics
Sequencing, alignment, variant calling, annotation, interpretation, and report generation all run on infrastructure inside this laboratory. No genomic data is handed to a third-party analysis vendor.
Laboratory-developed tests
Assays designed and validated by Prime Path under CLIA high-complexity standards — not resold kits, and not send-outs wearing our name.
Proprietary, curated panels
Gene content chosen against validity evidence and carved into clinically coherent sub-panels, published on every brochure rather than summarised as “comprehensive.”
A roadmap toward PLA codes
We are pursuing dedicated AMA Proprietary Laboratory Analyses codes for our developed tests — the coding that identifies an assay as ours.
Chain of custody
What actually happens to your patient’s specimen.
Four handoffs, all of them inside one building, each one recorded.
Accession
A specimen arrives with a completed requisition and two patient identifiers. It is logged, assigned an internal accession number, and checked against our published acceptance criteria before anything else happens. Specimens that fail those criteria are not run and not billed — they are reported back to you with the reason.
Analysis
Toxicology moves to immunoassay screening and, where ordered, to LC-MS/MS confirmation. Molecular infectious disease and genomic panels move to real-time PCR or targeted next-generation sequencing. Every run carries internal quality controls. Every instrument carries a documented validation record.
Interpretation
Raw signal becomes a result only after review. Our director is credentialed by the National Registry of Certified Chemists in Toxicological Chemistry, and no toxicology report leaves this laboratory without passing under that credential.
Release
Results are delivered to the ordering provider through the secure portal, by fax, or over an HL7 interface. Not to the patient, not to a marketer, not to a data broker. The report names the laboratory, the director, and the CLIA number that stands behind it.
The person who signs
Wenbing Chen, Ph.D.
A laboratory director is not a title on a wall. It is a name attached to every number you act on.
Under 42 CFR 493.1443, the director of a high-complexity laboratory who holds a doctoral degree rather than a medical degree must be certified by a board approved by the Department of Health and Human Services. Dr. Chen holds certification from the National Registry of Certified Chemists in Toxicological Chemistry — an HHS-approved board.
We publish this because the alternative is a website that says “board-certified specialists” in the plural and names none of them. Ordering physicians are entitled to know exactly who assumes technical responsibility for the result they are about to write into a chart. At Prime Path, that person is one individual, he works in the building, and his name is on the report.
The same principle governs the phone. When you call about a result, you are not routed into a queue. You reach the laboratory. If your question is scientific, it goes to the scientist who ran the specimen.
Instruments & methods
Platforms we run, named.
| Discipline | Method | Platform | Turnaround |
|---|---|---|---|
| Toxicology — presumptive | Immunoassay screen with pH, specific gravity and creatinine validity testing | Automated analyser | 24 hours |
| Toxicology — definitive | Liquid chromatography–tandem mass spectrometry | LC-MS/MS | 24 hours |
| Infectious disease | Real-time multiplex PCR with antimicrobial resistance markers | Thermo QuantStudio | 24–48 hours |
| Pharmacogenomics | Targeted genotyping | Thermo QuantStudio | 5–7 business days |
| Genomic panels | Targeted next-generation sequencing | Illumina NextSeq | 7–10 business days |
Turnaround is measured from the moment a specimen is received at our Denver facility, not from the moment a courier collects it. Times extend when reflex testing is clinically indicated, and we tell you when that happens rather than letting the clock run silently.
Sequencing, bioinformatics, secondary analysis, variant interpretation, and report generation are performed in-house. No genomic data is transmitted to a third-party analysis vendor. For a laboratory handling hereditary cancer risk and pharmacogenomic profiles, that is not a feature. It is the minimum.
Quality systems
What “validated” means when we say it.
Validation is the least visible and most consequential thing a clinical laboratory does.
Characterised, not assumed
Accuracy, precision, analytical sensitivity and specificity, reportable range and reference intervals are established on the instrument that will run your patient’s specimen — in this building, by this staff.
Controls stop runs
Every analytical run carries internal quality controls. A control outside limits halts the run. It does not become a footnote on a report.
Graded by outsiders
We participate in proficiency testing: blinded specimens of known composition, graded against peer laboratories running the same method. It is the closest thing diagnostics has to an unannounced exam.
Discrepancies are recorded
When something disagrees — and in a laboratory that looks honestly, things disagree — it is investigated, documented and corrected. That record exists whether or not anyone asks to see it.
Data custody
Your patient’s genome is not a business asset.
A potassium value describes a patient this morning. A hereditary cancer panel describes that patient for life — and describes their siblings, children and parents, none of whom consented to anything.
No third-party analysis vendor. No research cohort. No sale of data. Genetic information is protected as PHI under HIPAA and as sensitive data under the Colorado Privacy Act.
Results are released to the ordering provider through the secure portal, by fax, or over an HL7 interface. Patients exercising their right of access under 45 CFR 164.524 may do so through our Notice of Privacy Practices.
What we can show you
Verify us before you ship a single specimen.
Every laboratory website claims accuracy, speed and service. None of those words survive contact with a number. What follows is the paperwork behind the claims, published rather than described. Read it before you send us anything.
The specimen acceptance criteria document is the one we would ask you to read first. It is unglamorous and it is the reason our rejection rate is low: a specimen that was never going to produce a defensible result should be stopped at your bench, not at ours.
Scope and limits
Where we cannot help you.
A laboratory that will not name its limits is describing a sales territory, not a scope of practice. Ours are these.
We do not accept specimens from patients located in New York, California, New Mexico, Alabama, or Nevada. Those states operate their own laboratory permit regimes in addition to CLIA, and we do not hold permits in them. If your patient resides in one of those states we cannot perform the test, and shipping the specimen will only cost your practice time. Contact us and we will help you identify a laboratory that can.
We do not perform whole exome or whole genome sequencing. We do not run carrier screening. We do not maintain a reference-partner arrangement to make it look as though we do. Our catalogue is roughly twenty assays across three disciplines, and that is the honest extent of it.
We do not release results directly to patients. Laboratory testing at Prime Path is performed only on the order of an authorized healthcare provider, and the report returns to that provider. Information collected through this website is governed by our Privacy Policy; protected health information is governed separately by our Notice of Privacy Practices.
The standing offer
Talk to a scientist, not a call center.
Our director and bench scientists are available to discuss results, assist with panel selection, and support clinical decision-making after a report is issued.