In your office, on your bench
Pro-Lab gives your practice everything it takes to run a compliant, profitable in-office lab — equipment, FDA-cleared assays, Pro-LIMS with integrated billing, collection kits, consumables, and a CLIA-certified backup lab. One vendor. One contract. One call when something needs attention.
Reference labs measure turnaround in days. Your in-office bench measures it in minutes. For acute syndromes — UTI, pharyngitis, respiratory, vaginitis, GI — that difference rewrites the visit. The patient leaves with a result. You prescribe with the susceptibility data already in front of you, not a 48-hour callback later.
Sample leaves the office on a courier. Patient leaves with no answer. Empiric prescribing fills the gap.
Sample to result on your bench. Targeted antibiotic chosen before the prescription is called in.
Rapid molecular panels return pathogen identification and key resistance markers (e.g. mecA, ESBL, vanA/B) inside the visit. For UTI, strep, respiratory, GI, and vaginitis workups, you can have actionable susceptibility information in front of you before the prescription is called in to the pharmacy — not 48 hours later as a callback. Better stewardship. Fewer phone calls. Patients adhere because they leave with the right answer.
Time-to-result varies by assay, sample type, and instrument. Rapid molecular panels (Pro-Amp™ and equivalents) return pathogen ID and selected genotypic resistance markers within the visit; phenotypic susceptibility for less-common organisms may still require traditional culture timing. Pro-Lab maps your patient population to the highest-yield same-visit menu before recommending instrument placements.
Your patients wait. Your staff chase results. Your practice eats the margin a lab is supposed to capture. None of this is news to physicians who've tried to make the reference-lab model work.
Faxes that never arrive. Orders that disappear in someone else's LIS. You rebook the patient or call without a result.
Analyzers cost real money. Maintenance contracts cost more. The math works only if utilization is steady — and that's a leap for a small practice.
Stark, Anti-Kickback, EKRA, in-office ancillary services exception, CLIA waiver vs. compliance. Most physicians don't want to become regulators.
One analyzer goes down on a Tuesday and the whole in-office model breaks. Without a backup pathway you're sending out anyway.
Instrument vendor, reagent vendor, LIMS vendor, billing service, PT program, training contractor. Six contracts to run one lab.
Wrong CPT, missed QW modifier, payer-specific edits, denials that age into write-offs. Reimbursement only works if billing is right the first time.
COVID forced payers, providers, and CMS to accept testing where the patient is. The infrastructure caught up. The economics flipped. Centralized reference labs are no longer the only place a sample can land.
Six functions, one partner. We provision, deliver, configure, and keep all of it running.
We supply the analyzers and instrumentation. You don't source equipment from three vendors and reconcile their service contracts.
FDA-cleared assays engineered to be faster and easier to run than competitive equivalents — with reagents and controls included.
Pro-LIMS® is purpose-built for clinical labs. The integrated billing module handles CPT, modifier QW, payer edits, and denials with AI assistance.
Swabs, transport media, gloves, reagents, controls — everything from sample collection to result, replenished on schedule.
ISO 13485 manufacturing. FDA-cleared products. CMS-aware billing. Documentation supporting Stark in-office ancillary services positioning.
One number. Real humans. Instrument issue, billing question, PT event, audit prep — same line, same team, same day.
Pro-Lab Diagnostics USA isn't a startup distributor. We design, manufacture, and certify the products you'll be running.
Medical-device quality management system audited annually. Not a reseller bolted onto a brand.
Prolex®, Microbank®, Pro-Amp™ panels, Amniotest®, Transvelope® and more — registered IVDs.
labtest.bio is our high-complexity CLIA lab. Use it as overflow, send-out, or backup when an instrument needs service.
The Pro-LIMS billing module is built around the CLFS, CPT, and QW modifier logic that POL claims actually need.
We supply documentation supporting Stark in-office ancillary services exception positioning. Your counsel renders the legal opinion; we hand them the file.
Manufacturing, distribution, validation, and field support across thousands of clinical laboratories.
Illustrative, not a guarantee. Assumes a small primary-care practice running a CLIA-waived menu — common labs ordered every visit. Real numbers depend on payer mix, test menu, and volume.
| Assumption | Value | Notes |
|---|---|---|
| Tests run per month | 400 | ~20 patients/day × 1 in-office test × 20 working days |
| Avg. reimbursement per CLIA-waived test | $15 – $35 | Range cited by industry sources for common waived tests |
| Monthly gross at $20 average | $8,000 | Revenue captured in the practice instead of routed out |
| Reagent + consumable cost (illustrative) | ~$2,400 | Varies materially by test; bundled in your Pro-Lab program |
| Net contribution / month (illustrative) | ~$5,600 | Before Pro-Lab program fee. ~$67K/year captured. |
Figures are illustrative for planning conversations only. Pro-Lab does not guarantee specific reimbursement, volumes, or margins. CMS Clinical Lab Fee Schedule rates are published annually; commercial-payer rates vary. We'll model your specific test menu and payer mix during the consultation.
Pro-LIMS doesn't just submit claims — it scrubs them with payer-specific rules, flags errors before they ever reach the carrier, and works the appeals queue when something does come back. Here's what that looks like.
Figures shown are illustrative for planning conversations. Actual denial rates, error breakdowns, and appeal recovery vary by payer mix, specialty, claim volume, and practice billing history. Pro-Lab does not guarantee specific outcomes.
If it touches the lab, it's part of the program.
Honest answers — including the parts your counsel will want to verify themselves.
Tell us about your practice — number of physicians, specialty, current testing pattern. We'll come back with a written, specialty-specific proposal within 3 business days.
