Made in Flanders: miDiagnostics launches ultrafast PCR test
The faster, the better! For COVID testing, at least, this is definitely the case. That’s why miDiagnostics, a rapidly growing biotech company from Flanders, set out to develop an ultrafast COVID PCR test. Now that it has been CE-IVD certified, the new test is available for use across Europe and other territories that work with CE-IVD certification, providing a powerful pandemic and endemic management tool where fast and reliable decentralized testing is key.
Based on chip tech from imec
By launching its ultrafast PCR test, miDiagnostics is entering the commercial phase for its first product, marking an important milestone in the company’s development. Developed in collaboration with Johns Hopkins University, the new test is based on proprietary silicon chip technology from imec, Flanders’ strategic research center for nanotechnology and digital innovation.
The launch of our COVID-19 PCR test is a major milestone. It marks the transition of miDiagnostics into a commercial organization. All our attention is now on the scale-up and production of enough tests to cater to the market demand.
It is exciting to see that the work we began, as part of a collaboration between imec and Johns Hopkins University, was instrumental in the inception of miDiagnostics' transformative technology.
Fast and reliable testing on a microchip
The RT-qPCR process combines two testing techniques to enable the measurement of RNA levels in test samples. By miniaturizing this process, miDiagnostics has made it possible to diagnose COVID-19 infections with the accuracy, sensitivity and reproducibility of a traditional PCR test, but with the convenience and speed of an antigen test. As a result, within a mere 30 minutes after registering for a test on-site, patients can receive their results. The real-time PCR test itself takes less than 15 minutes.
Simple to use
What’s more, the test is very simple to perform: following a nasopharyngeal swab, the resulting sample is dissolved in a buffer solution and mixed with detector chemicals. Then, it is loaded onto a disposable PCR card and processed in a compact reader that allows for ultra-fast temperature cycling and optical detection. Plus, thanks to the use of disposable PCR cards, the risk of cross-contamination is minimal.
A powerful tool for pandemic management
The performance of the new ultrafast PCR test was confirmed through a large independent clinical study, led by Prof. Dr. Jan Verbakel of Leuven University (Flanders), that involved 766 test subjects. The subjects were tested for COVID infection using both miDiagnostics’ faster method and a traditional, decentralized (and slower) RT-PCR test. The first method showed solid equivalence with the results obtained from the reference method, making it a powerful tool for swift pandemic management.
In our evaluation study, we found that this new point-of-care SARS-CoV-2 assay, which delivers a result in 12 minutes, has a diagnostic accuracy comparable to that of lab-grade equipment. This technology could aid the management of outbreaks in challenging settings, such as nursing homes, allowing healthcare professionals to adjust their management decisions at the point of care.
Having been CE-IVD certified, miDiagnostics’ COVID-19 test can now be used by lab professionals in all countries that accept CE-IVD marking. Moreover, its compact design, ultra-fast workflow and strong reliability make it ideal for use in a decentralized setting, for instance in the travel industry. In fact, the test’s added value has already been demonstrated in a recent, successful pilot study at Brussels Airport in Zaventem (Flanders).
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press release miDiagnostics
