Quality Innovation, Fast & Affordable
Quality Innovation, Fast & Affordable
We are a team of seasoned R&D scientists and engineers located in Ottawa of Canada and with decades of experience developing in-vitro diagnostic (IVD) products, specializing in point-of-care testing (POCT). Our mission is to help our customers accelerate product development while ensuring high quality and cost-effectiveness. We achieve this by rigorously following design control procedures and strategically leveraging our engineering and manufacturing resources, including those in China.
Our core leadership includes Dr. Roy Zhao and Mr. Antti Virtanen, supported by a multidisciplinary engineering team. Dr. Zhao earned his PhD in Biomedical Engineering
from Karolinska Institute, Sweden. During his 17 years in the IVD industry, he served as Principal Scientist and VP of Technology at two separate IVD companies. He directed technical teams to successfully bring several POCT products from concept to commercial launch, including a PT/INR Analyzer and an Automatic Microfluidic qPCR Analyzer. Notably, over 10,000 of the PT/INR Analyzers are currently in use globally by cardiovascular patients.
Mr. Virtanen holds an MSc degree in Organic Chemistry from the University of Turku, Finland.
With over 18 years at a world-class POCT company, he has led the development of numerous assays, including quantitative hs-TnI for aiding in rapid diagnosis of myocardial infarction and TBI for measuring the level of biomarker associated with brain injury. His expertise lies in microfluidics, leading cross-functional teams, and successfully collaborating with manufacturing, regulatory, and quality departments to bring innovative diagnostic solutions from concept through commercialization.
Our team with strong expertise in IVD reagent, electronics, software and mechanical engineering has delivered medical device solutions for more than a dozen customers worldwide. Together, we combine deep scientific knowledge with practical development expertise to bring innovative diagnostic products to market efficiently and reliably.
The handheld PT/INR analyzer is intended for both professional and personal use. It provides an INR value in less than 1 minute after inserting a disposable test strip into the analyzer and loading a drop of fingertip blood onto the test strip. The INR value can help certain cardiovascular patients monitor the dosage of oral anticoagulant Warfarin. Our team defined the product requirements and specifications, developed the reagent, designed the test strip and the analyzer including electronic circuits, software and mechanical parts. We also led the design verification and validation including the clinical trials, and completed the registration with NMPA and CE Marking.
This point-of-care molecular diagnostic platform consists of an analyzer and a test cartridge. It integrates microfluidics with fluorescent PCR technology, making the whole diagnostic process fully automated, including DNA extraction, DNA solution metering, multiplexed PCR amplification, melting and data analysis. The cartridge can be used for testing various target genes by preloading different reagents and running different programs. The system provides fast and accurate qualitative and quantitative PCR, melting curves, and genotype analysis. Our team defined the product requirements and specifications, designed the microfluidic cartridge and the analyzer including electronic circuits, software and mechanical parts.
The Fecal Sample Processor is designed for automatic homogenization of fecal samples. It consists of the Sample Transfer, Weighing, Capping, Liquid Adding, Homogenizing and Barcode Scanning modules. For each sample, the Processor automatically weighs the sample and determines the amount of preservation solution to be added. The Processor uncaps the sample tube, adds preservation solution into the sample tube, and then caps the sample tube and transfers it to the shaker. The Processor can completely replace all of the manual operations, increasing the work efficiency and reducing biological risks. Our team defined the product requirements and specifications, designed the electronic circuits, software and mechanical parts.
This fully automated DNA extractor is based on the magnetic bead adsorption method. When a magnetic rod is inserted into a plastic sleeve, the magnetic beads are adsorbed onto the surface of the sleeve, moved to another reaction site, and released after the rod is pulled out of the sleeve. In this way, the magnetic beads can be collected, transferred and released among a series of reaction wells each containing specific reagents. This process allows for the extraction of high-quality nucleic acids from biological samples. Our team defined the product requirements and specifications, designed the electronic circuits, software and mechanical parts.
This pathological lab workstation integrates the functions of immunohistochemistry (IHC), fluorescence in situ hybridization (Fish), HE drop staining, nucleic acid molecular hybridization (HPV) and liquid based cell staining. It is the first in the industry and can be used in bioengineering, cell or tissue staining and other fields. Our team defined the product requirements and specifications, designed the electronic circuits, software and mechanical parts.
This semi-automatic 8-channel liquid dispenser works as 8 pipettes and moves liquid from 8 wells to another 8 wells simultaneously. It is a cost-effective, high precision and easy to use liquid handling device designed for 96-well plate pipetting. It simplifies the tedious and repetitive liquid dispensing, reduces errors. Our team defined the product requirements and specifications, designed the electronic circuits, software and mechanical parts.
We provide comprehensive product development services to IVD companies in North America, including:
We adhere rigorously to design control procedures in full compliance with CE, FDA and Health Canada requirements. Our structured product development process ensures efficiency, reliability, and regulatory readiness:
Our deliverables include fully functional prototypes and complete technical documentation, prepared for submission to regulatory authorities, e.g., CE Marking, FDA and Health Canada.