IVD Development

The Omnica technical staff has been involved in the development of laboratory IVD instrumentation for much of their careers. We have worked with chemiliuminescense, photometric, amperiometric, and fluorescence technologies, and are well versed with clinical and immunoassay analyzers, immunoassay washers, and liquid handling devices.

Utilizing chemiluminescence Omnica developed a POC instrument for measuring PSA levels. The project featured a patented, fluid-filled assay pack that we developed. Unique to the development was a novel manufacturing process to construct and fill the consumable reagent packs. At the push of a single button the FastPak® system provides laboratory precision immunoassay results in a few minutes.

For another project, out team designed a novel lateral flow electromagnetic immunoassay analyzer using paramagnetic particles as the biomarker label carrier. The biologic and chemical agent identification system utilizes a lateral-flow consumable cassette that we designed and prototyped at our facility. The current generation of the product has broad applications in medical diagnostics, food safety testing, veterinary health, biodefense, and environmental testing.

For a another firm we developed a liquid-handling POC device (for breast cancer risk assessment). The system used EVA, a waterproof, resilient, and flexible thermoplastic as the barrier material. Our team constructed 12 working prototypes of the tabletop device.

We have developed somewhat of a specialty in Mass Spectrometry technology. Using Time of Flight (TOF) the system uses a distributed CAN bus architecture. All firmware and system control software (excluding the pathogen DNA database) was developed by Omnica. In the course of the project we obtained six patents in the field of electrospray ionization and other areas.

Our R&D Group collaborated with Purdue University on a mass spectrometry project that combined paper chromatography and electrospray ionization. We performed the design and engineering for the entire system including the cassette, reagent injectors, high-voltage system, automated magazine, status display, and the Graphical User Interface. The result of the work was the first commercial product to use a PaperSpray ionization source.

Omnica continues to develop IVD devices, instrument systems, and consumables for clients in the areas of real-time PCR laser-induced fluorescence, magnetic particle-based PCR assay technology, and other POC platforms. Presently we are working on multiple projects that involve cartridge designs with corresponding instruments.