miDiagnostics
Lightning-Fast Results for Molecular Diagnosis

Even with the world nearing the endemic phase, routine testing for SARS-CoV-2 will remain critical across all institutions. In hospitals, every patient with a complex medical condition has to undergo qPCR testing before getting treatment for the ailment. The average 24-hour wait time for test results can have serious repercussions on their health. To avoid potential complications, IVD manufacturer miDiagnostics has designed a device that combines the best qualities of the classical RT-qPCR and antigen testing, aligned with the high demand for satellite laboratories at the point of need. The solution miDiagnostics is designing will be used in healthcare institutions, pharmacies, elderly homes, professional sports, for corporate health, at event locations – basically, at any point of need.

“Our device, an ultra-fast and user-friendly mobile equipment, delivers lightning-fast results like an antigen test with the accuracy, sensitivity, and reproducibility of a RT-qPCR test,” states Katleen Verleysen, CEO of miDiagnostics. The PCR-test is performed in less than 12 minutes with the same efficiency and accuracy as laboratory equipment.

These functionalities are achieved through the silicon nanoFluidic processor (nFP) incorporated in the device’s core. The nFP chip was initially developed by the leading R&D hub in nanoelectronics and digital technology, imec, in close collaboration with experts at Johns Hopkins University. The utilization of these high conductivity chips helps miDiagnostics attain high levels of miniaturization and speed.

The COVID-19 PCR test device designed by miDiagnostics is a combination of three modules—a sample tube, COVID-19 Assay, and a PCR system with disposable test cards. The test’s workflow is extremely simple: For every patient, an oropharyngeal or nasopharyngeal sample is collected. The sample is dissolved in a buffer solution, mixed with detection mix, loaded onto a disposable PCR card, and processed in a compact reader that performs ultra-fast temperature cycling and optical detection. Once the procedure is complete, the reader displays the results on a PC. The risk of cross-contamination is minimized thanks to the one-time use of the disposable PCR card per patient.

An additional feature that highlights the benefits of miDiagnostics’ system is its ability to rapidly process any biomarker. This indicates a future scenario where the equipment can potentially be used to test a range of clinical specimens in swab samples obtained from secretion, tissues, or body fluids collected during a physical examination. By utilizing miDiagnostics’ solution, the swab sample can be processed simultaneously with the physical examination, providing accurate results during the consultation.

Catering to clients’ needs, miDiagnostics offers effective and high-quality services during deployment. The equipment’s setup is essentially plug-and-play and doesn’t require an expert. Due to the lack of motorization, the instrument has no scope of maintenance.

With a mission to provide a comprehensive range of health screening tools for diagnostic access to everyone, everywhere, and at anytime, miDiagnostics is set out to seek similar opportunities in the near future, facilitating major impact on the healthcare industry and people’s lives.