Introducing
We want you to get tested… wherever you are. An ultra-fast, dual-capacity ultra-sensitive immunoassay and nucleic acid test at the point of care β results in under 5 minutes.
The problem
In countries like the United States, where testing can be extremely expensive, governments need to make diagnostics cheaper and more accessible to everyone.β Bill Gateson pandemic preparedness and health systems
The most consequential clinical decisions β in the OR, the ER, the ICU and the doctor’s office β still wait on central labs. ubiqui-Dx sets new standards for accessible diagnostics with decentralized, fast (<5 minutes) and ultra-sensitive point-of-care solutions at a low cost.
20 minutes to hours for centralized lab results β even >30 min in a doctor’s office β delaying critical treatment decisions exactly when physicians need them.
Most testing is still relegated to central and private labs. Faster, more comprehensive testing needs to reach the doctor’s office, ER, OR and ICU.
An ultra-fast (<5 minutes), ultra-sensitive immunoassay at the point of care β lab-grade results without the lab.
Executive summary
Why sensitivity matters
Read top to bottom: as concentration falls, the test must get more sensitive. Below the ELISA and Simoa floors, standard tests read “normal” even when disease is present. Only ubiqui-Dx reaches the bottom.
Each hour of delay adds +7% mortality. No point-of-care test exists today.
ELISA misses early MI; a 2-hour delay adds +30% mortality.
Sideline GFAP is undetectable by ELISA β a second-impact risk.
A 10-year pre-symptom window β needs femtomolar sensitivity to see it.
Stage I: >90% 5-year survival vs. Stage IV: 15%. Earlier detection saves lives.
Sources: ESC 2020 hs-Troponin Algorithm Β· JAMA Network Open 2024 (GFAP/TBI) Β· Chest 2020 (PCT/Sepsis) Β· Lancet Neurology 2021 (pTau-217) Β· NEJM Evidence 2023 (PSA) Β· Walt Lab / Wyss Institute (Simoa)
Sensitivity Γ speed
Plotting total assay time against limit of detection, the MFSD test reaches the fast, ultra-sensitive top-right corner that no other immunoassay or molecular method occupies.
Speed and sensitivity together enable faster and more precise medical decisions.
If decisions can be made at the bedside or in the doctor’s office, the improvements to testing workflows can decrease overall healthcare costs.
The technology Β· MFSD
Patented Β· McGill University Β· Prof. David Juncker Lab. A simple polymer membrane with half a million 8-Β΅m pores acts as an array of Brownian affinity traps β sieving 200 Β΅L in about a minute, then detecting single molecules.
| Feature | ELISA (Lab) | Quanterix (Core Lab) | ubiqui-Dx (POC) |
|---|---|---|---|
| Sensitivity | ~pg/mL | ~fg/mL | zM (10β»Β²ΒΉ) |
| Dynamic range | ~2 logs | ~3.5 logs | 6+ logs |
| Time to result | 4β6 hrs | 1β2 hrs | <5 min |
| Setting | Central Lab | Core Lab | POC / Home |
| Molecular | N/A | N/A | Yes (bimodal) |
Validated performance
Benchmarked against ultrasensitive digital immunoassays and PCR β extending both the lower and upper limits of detection.
~350Γ more sensitive with a 7-order-of-magnitude dynamic range, taking immunoassay from 3β4 hours down to 5 minutes.
For nucleic-acid detection (miR-141): PCR-class sensitivity, but faster, isothermal and far simpler β up to ~10Γ more sensitive simply by increasing volume.
Sensitivity scales linearly with sample volume β from 1,250 to 150,000 positive traps as volume increases at 80 aM analyte.
Market opportunity
io-PTH is only the beginning for an ultra-fast, ultra-low-cost, ultrasensitive platform built on four pillars: low cost, easy to use, very fast and ultrasensitive.
References: Coherent Market Insights 2025 Β· DataIntelo 2024 Β· Grand View Research 2024β25 Β· GrowthMarket Reports 2024 Β· MRFR 2024 Β· MarketsAndMarkets 2024. SAM = 10β20% TAM penetration estimate (POC-accessible procedures in academic + community hospital settings).
Focused IVD entry
Real-time, whole-blood, sub-pg/mL quantitative io-PTH at the OR table in under 5 minutes β eliminating OR dead-time and reducing the chance of re-operation.
Four-year roadmap
Development is synergistic across chemistry, engineering and manufacturing β leveraging AI to optimize R&D, manufacturing and strategic decisions.
Build proof-of-concept for the instrumented solution and pre-clinical validation. ~24 months to POC and pre-clinical validation; clinical validation starts in year one.
Complete prototyping and clinical trials. 12β16 months to clinical-trial readiness, then 6β12 months of clinical trials toward MFSD POC FDA 510(k) submission, CLIA-waived.
Global scaling. Source and scale manufacturing toward full automation; scale commercial operations and manufacturing worldwide.
The people
Global operator with 30+ years from sales to CEO across Roche, Merck/Millipore, Quanterix and Domus.
Leading McGill scientist, co-founder of NOMIC Bio, with 15+ inventions and patents in microfluidics and assays.
PhD in Juncker’s lab and co-inventor of the BATS / MFSD technology at the core of the platform.
30-year operator and executive; former CEO of Singulex and Mainz BioMed, with 20 years at Roche.
Former CTO & SVP R&D at Quanterix; former VP Research & Operations at Twin Lights Bioscience.
Former EVP & Chief Medical Officer at bioMΓ©rieux; former Full Professor of Medicine at McGill University.
Former Staff Scientist, R&D Strategic Initiatives across Abbott’s Rapid Diagnostics and Point-of-Care divisions.
The opportunity