With sensitivity and specificity rivalling that of central lab devices, BluSense Diagnostics enables fast and high-precision virus screening

Sandy Du, DIGITIMES, Taipei 0

As the COVID-19 pandemic continues to ravage countries across the globe, screening has become a necessary weapon for fighting the epidemic. Currently utilized testing methods, however, require professional processing, and results are not available until at least four hours later. In response to this pain point, BluSense Diagnostics has developed BluBox, a portable medical testing platform that eliminates the need for sample pre-processing and shortens testing time to just six minutes.

As Jessie Sun, president of BluSense Diagnostics, indicated, COVID-19 virus testing is just one of the applications of BluBox, and that the device can be widely used for a number of other infectious diseases including the two most devastating infectious diseases globally, dengue fever and Zika. The above two constitute BluSense Diagnostics' primary scopes of research, and the company has forged partnerships with research institutes and medical institutions in Taiwan and overseas to introduce the testing technology and device to regions most deeply affected by the two diseases to safeguard the health and wellbeing of the local communities.

"BluSense Diagnostics, established in 2014, is a multi-national startup rarely found in Taiwan built upon an academic collaboration between the Academia Sinica and the Technical University of Denmark," said Sun. In the early stages of research and development, BluSense Diagnostics was able to obtain support offered through the Ministry of Science and Technology's Germination Program as well as funding provided by Quanta Storage. The company seeks to optimize the procedures and efficacy for infectious disease testing utilizing new technologies. It currently operates out of both Taiwan and Denmark with the former focusing on hardware and software and the latter focusing on biotechnology R&D.

BluBox's three major advantages of high precision, lightweight portability and simplified procedures yield faster testing

According to Sun, BluSense Diagnostics has from the very start placed its focus on testing for mosquito-borne infectious diseases with dengue fever and Zika virus the two primary areas of emphasis. "The fact may not be widely cited, but according to WHO data, as many as 390 million people are infected with dengue fever globally a year. This is a disease with a significant mortality rate," Sun said. She explained that although the recovery rate for first-time infections are relatively high, secondary infection will lead to higher risk of severe illness with mortality rate rising to 20% if the disease is not immediately treated. Therefore, the focus of preventive medicine is determining whether antibodies are present within the human body. If lgG antibodies are already present, the patient will require further treatment. The technology can also be used to quantify antibody levels in patients who have contracted COVID-19. Apart from determining whether the patient has been infected with the COVID-19 virus, testing can be used to trace contact history and regularly track in vivo antibody levels for individuals who have been vaccinated with COVID-19 vaccines to verify whether antibodies have been generated after inoculation.

Sun pointed out that there are currently three methods for screening infectious diseases, including using the aforementioned lab-grade large-scale equipment, screening stations set up in public spaces, and handheld testing devices that enable testing to be conducted at any location. Each of these approaches have their pros and cons; for instance, large-scale equipment offer high precision but testing is complicated and arduous, while rapid screening drastically reduces testing time but offers questionable precision with testing results prone to human error. Handheld devices on the other hand are a mix of the two as testing is still mostly performed by professionals and testing time still takes over an hour.

BluSense Diagnostics however has developed a product that combines the advantages of all three approaches above. Using the BluBox, a portable IVD device, and ViroTrack, cartridges containing nanoparticles and microfluidic structures, testing can be completed within six minutes using just one drop of blood. No pre-processing is required, and both sensitivity and specificity are above 90%, which is comparable to that of large-scale devices at central labs. Jessie highlighted that BluBox not only offers exceptional sensitivity and specificity but is easy to operate by any non-professional. As it is small and portable, it can be used in a variety of venues apart from medical institutions, including airports and ports where on-site testing is vital.

Outstanding performance, international verification and unlimited future business potential

BluSense Diagnostics has completed multiple clinical trials all over the world and collected data on large numbers of samples through these trials compatible with testing results generated by large-scale equipment using enzyme-linked immunosorbent assay (ELISA). Marketing-wise, Europe and Southeast Asia are BluSense Diagnostics' two major target markets. Products are marketed and sold through regional distributors who provide local hospitals and vendors with fast, convenient and high-precision testing equipment.

BluBox's superior performance has become the focus of attention for global medical industry, and Jessie attributes this to not just the dedication of the BluSense Diagnostics team but also the crucial support offered by Taiwan Tech Arena (TTA). According to Jessie, most academic research teams were previously hesitant to engage in entrepreneurship due to lack of momentum in Taiwan's startup environment. Following the government active efforts in fostering startup culture, Taiwan now has a startup ecosystem similar to that of Europe and the US with ample resources and funding. "BluSense Diagnostics, for example, was able to establish partnerships with foreign enterprises and gain media presence with the assistance of TTA, and these advantages have been instrumentally conducive to our growth." Going forward, while continuing to invest in R&D, BluSense Diagnostics will be expanding the application of its products to offer the market the best testing solutions.

(Editor's note: The original article was published in TTA Magazine Issue 7. Read more startup stories in TTA Magazines.)

BluSense Diagnostics' s BluBox.

BluSense Diagnostics' s BluBox.
Photo: BluSense Diagnostics