The Taiwanese start-up iXensor announces this Friday, June 4 that it has obtained the CE-IVD (in vitro diagnostic medical device) marking for its self-test on a smartphone “Pixotest”. This precious sesame allows him to market his product within the European Union. The marketing price is not disclosed.
This young growth, which took its first steps in Silicon Valley before settling in Taipei, specializes in medical diagnostics on smartphones. In 2017, it launched a blood glucose monitoring system, dubbed Pixotest, which was approved by the Federal and Drug Administration (FDA) in the United States.
A self-test on a smartphone
Building on this initial success, iXensor decided to embark on the self-test sector to detect SARS-CoV-2, the virus responsible for Covid-19. Pixotest works as follows: the person will take a nasopharyngeal or nasal sample using a swab and then place this sample on a reader installed on a smartphone.
The sample images are captured by the phone’s front camera and analyzed by a proprietary algorithm. In less than five minutes, Pixotest will give its result with a sensitivity of 93% for a nasal swab and 95% for a nasopharyngeal swab for intervals of 0 to 7 days since the onset of symptoms. Note that this is an antigen test and not PCR. It is therefore less reliable.
A health pass dedicated to self-tests
The results of the test are transmitted to the Pixohealth Pass application and transcribed in a QR code, which constitutes a sort of health pass, explains iXensor on its site. Indeed, authorized people will be able to scan it to accept that a person enters a place, moves … thanks to the Pixohealth Pass Admin application. A web portal offers professionals an overview of test results.
This medical device could be particularly interesting for airports, trade shows, schools. However, it raises many questions concerning the protection of health data. IXensor promises that the information collected is stored securely in its cloud, called Pixohealht Hub. But the company does not specify the geographic location of the data.
In addition, the integration of this device into the current testing and monitoring routes is not easy. Indeed, in France for example, the government has already implemented authentication of PCR tests via a QR code available in digital form in the TousAntiCovid application or on paper. On the other hand, self-tests sold in pharmacies cannot be authenticated because they are considered less reliable.
IXensor is not the first to have entered this market. Sanofi and the Californian start-up Luminostics have joined forces to develop a similar device, the presentation of which took place last April. The product should be on the market by the end of 2020. The partners have not communicated since this announcement.