iXensor receives CE-IVD mark for end-to-end rapid antigen testing solution

iXensor has received the CE-IVD mark for its PixoTest POCT COVID-19 Antigen Test. iXensor provides an end-to-end digitalised solution consisting of a rapid antigen test, a digital health and an admin app as well as a web portal for organisations to prevent further outbreaks.

iXensor's PixoTest solution comprises a palm-sized analyser that reads test results, a digital health pass App, an Admin App, and a HIPAA-grade health management web portal. The digitised testing and reporting design shortens the test-to-report time to 15 minutes. The solution allows for scaling in large screening settings in a bid to enable business continuity and reopening.

With the PixoTest POCT Analyser reading test results it aims to minimise the risks of having false-negative cases compared to rapid tests interpreted by human eyes.

The analyser transmits test results simultaneously to the PixoHealth Pass App users via an encrypted QR code. The digital health pass also records App users’ vaccination certificates, helping free movement in the upcoming summer holiday season.

The PixoHealth Pass Admin App is designed for organisations to verify the authenticity of PixoTest test results with one simple scan. The admin app protects organisations' safety amidst the pandemic by validating the cheat-proof, encrypted results shown on PixoHealth Pass App.

In the prospective clinical study completed in Brazil, the PixoTest showed 95% sensitivity and 98% specificity of nasopharyngeal specimens for the ranges of 0 to 7 days since symptom onset (DSO). Another study in the USA examined the clinical performance of anterior nasal specimens among symptomatic patients, which reported 92.8% sensitivity and 100% specificity, respectively.

Dr. Peter Fitzgerald, chairman of iXensor and emeritus professor of Medicine School at Stanford University said: "We are deploying iXensor's core PixoTech technology to develop the smartphone-based self-test that can perform COVID-19 testing and tracking, anywhere at any time. I believe having COVID-19 at-home test will drastically cut many transmission paths to stop the pandemic.”