BIO
BioArc Solutions
Texas‑based • POLs • Molecular • NGS • Bioinformatics

Build, validate, and launch high‑performance clinical labs

BioArc Solutions partners with physicians and reference labs to design POLs, stand up molecular & NGS testing, pass inspections, and automate analytics — with clear economics from day one.

• CLIA/COLA ready • Financial models included • Templates & training
Example Menu
  • ✓ UTI / STI PCR
  • ✓ Wound panel
  • ✓ RPP
  • ✓ PGx
Automation
  • ✓ UA report generator
  • ✓ QC dashboards
  • ✓ LIS integrations
Results we aim for
8–12 wks
Build‑to‑launch (best case)
$ margin
Unit economics modeled
100%+
Inspection pass track*
*Across supported builds; details on request.

What we do

Practical, inspection‑ready solutions from bench to business.

Physician Office Lab (POL) Setup

End‑to‑end design and stand‑up of in‑house labs: space planning, instrumentation, SOPs, and go‑live support for UTI, STI, wound, RPP, PGx, and more.

  • Workflow design & bench layouts
  • LIMS / accessioning guidance
  • Vendor selection & negotiation

CLIA/COLA Compliance & Inspection Readiness

Policies, QC/QA programs, competency, logs, and mock inspections so you pass the first time.

  • SOPs & quality manuals
  • Proficiency testing setup
  • Corrective action & document control

Validation & Verification (IVD/LDT)

Method validation/verification plans, templates, and execution for PCR, qPCR, and NGS workflows.

  • Accuracy / precision / LoD studies
  • Reportable range & reference intervals
  • Turnkey validation binders

NGS & Molecular Workflows

Extraction to library prep to analysis. SOPs for MagMAX/KingFisher, Qubit QC, and Illumina pipelines.

  • Panel design & selection
  • Controls & run acceptance
  • Phix, demux & metrics reviews

Bioinformatics & AI Automation

RNA‑seq, differential expression, SVM/RF models, and automated report generation (e.g., UA summaries).

  • R / Python pipelines & dashboards
  • Cloud or on‑prem deployment
  • Training & hand‑off

Business & Reimbursement Strategy

Financial models, CPT strategy, payer mix analysis, and break‑even roadmaps.

  • Volume & capacity planning
  • Per‑test COGS & margins
  • Go‑to‑market playbooks

Compliance first

We build to CLIA/COLA standards with HIPAA‑aware data handling.

CLIA
Policies, training, and documentation included.
COLA
Mock inspections and readiness checks.
HIPAA / PHI
Secure, compliant data practices.

How we work

Clear phases, concrete deliverables, and weekly check‑ins.

Step 1
Discover

Assessment of goals, menu, space, and budget.

Step 2
Plan

Roadmap with timelines, dependencies, and vendors.

Step 3
Build

Procurement, setup, LIS/LIMS, and SOP drafting.

Step 4
Validate

IVD/LDT validations, QC programs, and training.

Step 5
Launch

Go‑live, inspection readiness, and first‑month shadowing.

Step 6
Optimize

KPI dashboards, reimbursement lift, and expansion.

Selected outcomes

Anonymized snapshots representative of our work.

Family Medicine & Urgent Care
Six POLs launched across Texas
  • < 12 weeks build‑to‑launch in best case
  • Pass‑on‑first inspection track record
  • $500/test menu economics modeled
Oncology research group
NGS bioinformatics pipeline
  • Automated DE analysis (DESeq2/limma)
  • SVM model for staging with CV
  • Self‑serve dashboards & report exports
Reference Lab
Automation of UA clinical reporting
  • Python generator for PDF reports
  • Reduced TAT by 35%
  • Eliminated manual transcription errors

About BioArc Solutions

Hands‑on consultants who build and operate clinical labs with rigor and speed.

We are a Texas‑based consulting partner helping physicians and labs stand up and scale high‑complexity testing. Our team blends wet‑lab operations, quality systems, bioinformatics, and business strategy. We’ve supported multiple POL launches across Dallas and Houston and deliver inspection‑ready documentation along with training and knowledge transfer.

  • ✓ Dallas–Fort Worth & Houston coverage
  • ✓ SOPs, logs, and templates included
  • ✓ R / Python analytics expertise
  • ✓ Reimbursement & payer strategy
Core capabilities
  • POL setup & operations
  • Molecular (PCR/qPCR)
  • NGS workflows (Illumina)
  • Validation & verification
  • Quality systems (CLIA/COLA)
  • LIS/LIMS integrations
  • Bioinformatics & ML
  • Financial modeling

Ready to build?

Tell us about your goals — we’ll map the fastest compliant path to launch.

Schedule a call Request a proposal

Contact

We typically respond within one business day.

By sending, you agree to be contacted about your inquiry.
📧 info@bioarcsolutions.com
📍 Dallas–Fort Worth & Houston, Texas

Prefer a structured engagement? We offer fixed‑scope builds, monthly retainers for ongoing QA/analytics, and hourly advisory. Ask for our standard SOW.