A nationally scalable respiratory diagnostic platform designed to enable early detection,
reduce hospital burden, and protect vulnerable populations.
We develop and manufacture diagnostic solutions aligned with clinical utility, quality standards, and scalable deployment across healthcare settings.
Led by experienced operators and supported by senior regulatory advisors.
Represents a next-generation diagnostic platform designed to leapfrog current respiratory testing capabilities through earlier detection, broader multiplex coverage, and an expandable architecture that can evolve with emerging pathogens.
Designed for U.S.-based manufacturing and domestic supply chain resiliency.
A nationally scalable respiratory diagnostic platform designed to enable early detection, reduce hospital burden, and protect vulnerable populations.
We develop and manufacture diagnostic solutions aligned with clinical utility, quality standards, and scalable deployment across healthcare settings.
Led by experienced operators and supported by senior regulatory advisors.
Represents a next-generation diagnostic platform designed to leapfrog current respiratory testing capabilities through earlier detection, broader multiplex coverage, and an expandable architecture that can evolve with emerging pathogens.
Designed for U.S.-based manufacturing and domestic supply chain resiliency.
Our Manufacturing Facility
Production Environment
Three GMP grade clean rooms for the lateral flow assay production which ensures the highest level of production standards.
Automated Production Lines
Two fully automated production lines which minimizes human errors and increases production efficiency
High Production Capacity
Monthly production capacity of 300 million pcs
Our Services
We provide end-to-end capabilities in diagnostic development, manufacturing, and deployment.
- Lateral flow assay design and development
- Label and packaging design
- Production
- Quality control
- Clinical evaluation
- Documentation
- Logistics
Focus Area
Advancing a multiplex respiratory diagnostic platform designed for OTC and point-of-care use to enable earlier detection, reduce hospital burden, and protect vulnerable populations.
Products
- Qualitative lateral flow test kits
- Semi-quantitative lateral flow assays
- Quantitative lateral flow rapid diagnostic
- Cassette/Strip reading device
Why it Matters
- Designed to enable earlier detection and triage at the point of need — shifting care from the emergency department to the home, schools, and community settings
- Shifts the point of care to earlier detection and triage settings, with the potential to generate significant and measurable hospital diversion
- Addresses a diagnostic gap in upper respiratory detection
- Critical for children, seniors, and medically vulnerable populations
Advisors & Regulatory Support
Regulatory support includes Jim Sergi (CSSi LifeSciences / Qnova), bringing senior-level FDA and life sciences regulatory experience across product development, submission strategy, and commercialization pathways.
Our Commitment
We aim to deliver high-quality, cost-effective diagnostic solutions that improve point-of-care decision-making and patient outcomes.
Recommended Approaches
The complex world of infectious diseases and biological threats requires a full spectrum of solutions. We’ll work with you to develop and manufacture exactly what you need to keep your constituents safe and healthy.
Field Detection
The best methods for field detection are rapid immunoassays, handheld PCR devices, and biosensors.
Laboratory Confirmation
The best methods for laboratory confirmation are real-time PCR and next-generation sequencing (NGS).
Monitoring Large Areas
The best methods for monitoring large areas are environmental sampling with automated detection systems.
Contact Us
Please share your unique requirements, and our dedicated team will do our best to ensure that your needs are met.
Address
950 Main Ave #1100
Cleveland, OH 44113
Contact
+1 (800) 940-2007
info@osmedtech.com