Everything you need to know about running your genetic or molecular lab on Labrynix — the platform, the AI, PGx reporting, billing, integrations, security, implementation, and pricing.
What Labrynix is and which labs it's for.
Labrynix is one AI-powered platform for genetic and molecular labs that unifies LIS/LIMS operations, reporting, and billing in a single connected system — plus its own lab-trained AI layer that builds custom workflows, agents, and specialty-specific reports (PGx, oncology, neurology, and more). It is built by the team behind Gene Matrix AI, a CLIA-certified genetic lab, and every AI output is reviewed and signed out by qualified laboratory staff.
Most labs run a LIS, a separate reporting tool, billing somewhere else, and integrations cobbled together — so data is re-keyed and the picture is fragmented. Labrynix replaces that stack with one system where data captured once flows through operations, reporting, and billing, and adds a lab-trained AI layer that legacy LIS/LIMS vendors don't have, built specifically for genetic and molecular work.
Both. Genetic and molecular labs need patient-centric LIS capabilities (orders, results, reports, providers) and sample-centric LIMS capabilities (accessioning, tube/plate/well tracking, QC, instruments). Labrynix is a LIS/LIMS hybrid so a single record carries an order from intake through sample, result, report, and claim.
PGx labs, genetic testing labs, molecular diagnostic labs, hereditary cancer and oncology labs, reference labs, and lab networks — with workflows, reports, and integrations tailored to each. The reporting and billing logic is tuned for the realities of molecular and genetic testing specifically, not generic clinical chemistry.
Yes. Modules are adopted independently — many labs start with standalone PGx reporting and keep their existing LIS, connecting via API, HL7 v2, or FHIR, then add LIMS, billing, portals, or AI later. You buy the core platform and grow into the rest as it makes sense.
What the AI does, and the human guardrails around it.
Labrynix's AI drafts SOPs, builds workflows and lab-specific logic, automates routine work, and assembles draft reports across specialties. It assists; it never decides. Interpretation, validation, approval, and final sign-out always remain with qualified laboratory staff, every step is logged and traceable, and AI never makes the clinical decision.
No. The AI maps genotype to predicted phenotype, drafts summaries, and organizes source references, but a qualified staff member reviews, edits, approves, and electronically signs out every report. The platform is designed to make qualified review faster, not to bypass it.
Every gene-drug call is traceable to its CPIC, FDA labeling, DPWG, or PharmGKB basis, with version notes, expressed in standardized phenotype terminology. That transparency is deliberate: opaque, proprietary PGx engines have been shown to diverge from CPIC guidance, and a recommendation a lab can't explain is one a provider can't defend.
Yes — Labrynix's own AI layer, agents, and lab-specific logic are built on best-in-class foundation models and refined over years on real lab reporting. The differentiator is the lab-trained layer and the governed, auditable way it's applied under lab review — not the base model.
Coverage, evidence, branding, and specialties.
Labrynix PGx reporting delivers prescribing guidance across 700+ medications — both FDA-approved and over-the-counter — spanning cardiology, psychiatry, diabetes, pain management, and more. Coverage is informed by CPIC, FDA pharmacogenomic labeling, DPWG, and PharmGKB and applied under your lab's validated interpretation rules. See Labrynix PGx Reporting for the full picture.
CPIC guideline content, the FDA's table of pharmacogenomic biomarkers in drug labeling, DPWG, and PharmGKB annotations. No single source is sufficient — FDA labeling specifies an action for only some drugs and doesn't always agree with CPIC — so Labrynix reconciles all four under your lab's approved rules, with versioned updates.
Yes. The AI custom-builds modern, branded reports around your test menu — not a generic template — for PGx, oncology, neurology, carrier screening, cardiology, rare disease, and custom panels. Your lab reviews and signs out every one.
Yes. Logo, colors, layout, sections, disclaimers, and delivery are your lab's — the report reads as your product, because it is. Labrynix is the engine behind it, delivered as a PDF, through provider and patient portals, or back into your LIS/EHR via HL7 and FHIR.
Yes — view a free sample PGx report built on synthetic data to see the structure and house style, or book a demo to walk one of your own cases end to end.
Denials, MolDX Z-codes, and prior authorization.
Eligibility, coding, clean-claim generation, and denial management run off the same record as the order and the report — so the order data that causes most molecular denials is captured correctly the first time. Denial-reason analytics surface patterns for your team to act on. You can estimate recoverable revenue with the ROI calculator.
Yes. MolDX/DEX Z-codes are required by Medicare's MolDX contractors and a growing list of commercial and Medicare Advantage payers to identify a specific molecular test. Labrynix keeps the Z-code, CPT, and supporting documentation on the same record as the order and validates the combination before the claim goes out, so claims leave clean rather than coming back denied.
Yes. Prior-authorization status and medical-necessity documentation are tracked per order alongside the sample-to-report workflow — the documentation payers increasingly require to pay molecular and genetic claims — and handed cleanly to your billing and revenue-cycle process.
How Labrynix connects to your stack.
Bidirectional HL7 v2 and FHIR R4 interfaces with EHR/EMR systems (for example Epic and Cerner/Oracle Health), instrument and analyzer integrations, clearinghouse and billing connectivity, and a full REST and FHIR API to connect anything else. Labrynix Connect is the integration layer.
Yes — both HL7 v2 (the long-standing standard most EHRs and instruments speak) and FHIR R4 (the modern API-based standard), so Labrynix can exchange orders, results, and reports with the systems your lab and your ordering providers already run.
Yes. A REST and FHIR API lets you send orders and genotype data in and pull structured results and reports back — which is how labs run standalone PGx reporting without replacing their existing LIS.
Data protection, CLIA/CAP, and the regulatory picture.
Labrynix is built around HIPAA, SOC 2, ISO 27001, and GDPR — with timestamped audit trails, role-based access control, encryption in transit and at rest, and inspection-ready documentation. Your lab remains responsible for its own accreditation and clinical compliance; the platform is designed to support it. See the security overview for detail.
In HIPAA-compliant cloud infrastructure with encryption in transit and at rest, zero-trust access, and full audit logging. On-premise and private-cloud deployments are available for enterprise customers.
Yes. Labrynix provides the audit trails, access controls, validation records, and versioned documentation that CLIA and CAP inspections expect. The lab owns its accreditation and validates its own assays; Labrynix keeps the evidence organized and inspection-ready.
The FDA's 2024 laboratory-developed test rule was vacated in March 2025 and rescinded in September 2025, so CLIA — not FDA clearance — is again the operative framework for LDTs. In practice that means labs validate LDTs under CLIA/CAP, and the documentation that matters for software is CLIA/CAP validation evidence and MolDX support, which Labrynix is built to provide.
Implementation, data migration, and pricing.
It depends on your lab's size, test menu, and number of integrations — integrations are the biggest driver. Rather than quote a one-size-fits-all number, Labrynix scopes a realistic timeline during discovery and handles onboarding, data migration, and workflow configuration with you.
A data-migration approach is planned and validated as part of implementation, with the goal of full historical-data access — so you're not stuck running two systems for months.
Pricing is custom and modular: you start with the core platform and add AI reporting, billing, automation, and integrations as you grow. Cost is driven by the modules you select, your volume, portal and integration scope, and implementation support. Request a quote scoped to your lab.
Book a demo and we'll walk one of your own cases end to end, scope the modules and integrations you need, and put a realistic timeline and quote in front of you. There's no obligation and no sales pressure.
Book a 30-minute walkthrough with a lab-informatics person — no sales pressure.
