Friday, June 25

Taiwanese mobile health firm gets CE mark for its COVID-19 digital point-of-care test



iXensor, a Taipei-based mobile health solutions developer, received a CE-IVD mark for its PixoTest POCT COVID-19 Antigen Test.

WHAT IT DOES

The point-of-care test is an end-to-end fully digitalised rapid screening solution. It comprises a palm-sized analyser, a digital health pass app, an admin app and a HIPAA-grade health management web portal.

iXensor said in a statement that its diagnostic solution can provide results within 15 minutes.

The analyser transmits results simultaneously to the user’s PixoHealth Pass app through an encrypted QR code. The app also keeps the user’s vaccination certification, a credential needed for cross-border travel in many countries today.

Moreover, organisations can verify the authenticity of their members’ PixoTest result through the PixoHealth Pass Admin app.

WHY IT MATTERS

The PixoTest solution can be used in large screening settings, “thereby enabling business continuity and reopening”, iXensor said in a press release.

The rapid antigen test can also potentially minimise the risks of having false-negative cases compared to other rapid tests that are interpreted by human eyes.

Citing a result from a recent clinical study in Brazil, the company said the PixoTest showed 95% sensitivity and 98% specificity of nasopharyngeal specimens within seven days of symptom onset. Another study conducted in the US showed its 92.8% sensitivity and 100% specificity of anterior nasal specimens among symptomatic patients.

MARKET SNAPSHOT

There are other app-connected, point-of-care COVID-19 rapid tests available in the market. 

UK health tech firm Vatic is the latest to introduce a saliva-based test called KnowNow COVID-19 test that is deployable as a “frontline screening tool.” It provides results via a mobile app within 15 minutes.

Abbott also markets a $5 rapid test called BinaxNOW COVID-19 Ag Card, which delivers results through its NAVICA app within 15 minutes.

Data from Statista showed that the global point of care diagnostics market is expected to grow to over $40 billion in 2024 from around $21.5 billion in 2015. 

ON THE RECORD

“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,” said iXensor Chairman Dr Peter Fitzgerald, who is also an emeritus professor at Stanford Medicine.



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