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www.tga.gov.au/covid-19-test-kits-included-artg-legal-supply-australia

Manufacturer: iXensor Co Ltd (Taiwan)

Name of test: PixoTest® COVID-19 AG Test Kit

Australian sponsor: Pharma Soul Pty Ltd

Date approved for supply: 14 Sep 2021

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PixoTest ¸Ñ¨M¤è®×±N¥X²{°²³±©Ê®×¨Òªº­·ÀI­°¦Ü³Ì§C¡C

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.

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iXensor lance un autotest sur smartphone pour detecter la presence du Covid-19

Cette startup taiwanaise vient de recevoir le marquage CE-IVD pour Pixotest, la technologie capable de detecter le virus SARS-CoV-2. Grace a cette certification, l¡¦autotest va pouvoir etre commercialise au sein de l¡¦Union europeenne.

Par Valentin Cimino - @ciminix

Publie le 7 juin 2021 a 16h32

Apercu de l¡¦autotest developpe par iXensor.

Une startup taiwanaise presente un autotest sur smartphone. Image : iXensor

Nous aurons peut-etre bientot acces a un autotest sur notre smartphone. C¡¦est la startup taiwanaise iXensor, leader dans la sante sur mobile, qui est a l¡¦origine de cette innovation. Le 4 juin 2021, un porte-parole de la societe a declare que : le resultat est disponible en moins de 5 minutes et peut meme etre authentifie par un QR code. Une nouvelle innovation technologique, un peu plus d¡¦an apres le debut de la pandemie de Covid-19.

iXensor ±Ò°Ê´¼¯à¤â¾÷¦ÛÀË¥HÀË´ú Covid-19 ªº¦s¦b

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In addition to the PixoTestR POCT Analyzer, iXensor has prepared the mobile phone-based PixoTestR COVID-19 Antigen Test in the pipeline as the scalable solution. The PixoTestR Mobile Analyzer is running on iXensor¡¦s machine learning-enabled PixoTechR, possessing an immense scalability in addressing massive outbreaks.

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Dr. Peter Fitzgerald, Chairman of iXensor and Emeritus Professor of Medicine School at Stanford University announces, ¡§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.¡¨

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2021-06-02

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·|­û¡GAndy10135895  µoªí®É¶¡:2021/5/20 ¤U¤È 06:07:42²Ä 1053 ½g¦^À³
iXensor CEO Carson Chen discusses the future of pandemic prevention at Johnson & Johnson Innovation

2021-05-20

TAIPEI, TAIWAN; ¡V May 20, 2021 ¡V iXensor Co., Ltd. (6734.TWO)

Dr. Carson Chen, CEO of iXensor, today participated in Johnson & Johnson Innovation¡¦s webinar ¡§The Future of Pandemic Prevention: Innovation Ecosystem Collaboration¡¨ together with renowned experts including Rick Bright (SVP Pandemic Prevention and Response at Rockefeller Foundation, former director of BARDA) and Professors Jodie McVernon and John Tam.

The panelists addressed the question of how society can prepare itself better for future pandemics and what can be done to prevent them from happening. Carson Chen stressed iXensor¡¦s competence in the area of mobile health and emphasized the importance of mutually beneficial industry partnerships:

¡¨Through collaboration networks, startups like iXensor can run clinical studies more efficiently and thereby facilitate the go-to-market process. Partnerships help us to understand the market better and launch crucial products like our PixoTest® POCT COVID-19 Antigen Test faster¡¨.

He went on to remark that resilience is key when dealing with pandemics while other experts stressed the importance of preparedness.

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he Future of Pandemic Prevention: Innovation Ecosystem Collaboration Webinar Today!

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·|­û¡GAndy10135895  µoªí®É¶¡:2021/5/18 ¤U¤È 04:59:59²Ä 1048 ½g¦^À³
iXensor announces superior clinical accuracy of its fully digitalized PixoTest® POCT COVID-19 Antigen Test and management solution

iXensor, the pioneer of mobile health, is set to launch its end-to-end digital COVID-19 rapid antigen test solution that digitizes the entire user journey from screening, reporting to access control to combat outbreaks. The clinical performance evaluation has demonstrated superior accuracy of the PixoTest® POCT COVID-19 Antigen Test. The test is currently undergoing the CE self-declaration procedure, and is expected to become available under CE Mark soon using nasal swab or nasopharyngeal swab method.

The PixoTest® POCT COVID-19 Antigen Test is a smart rapid testing solution, which enables fast and cost-efficient screening at decentralized settings. It offers testees the PixoTest Pass app for free self-registration with privacy consent before testing. Then the PixoTest® POCT Analyzer analyzes specimens and transmits test results simultaneously to PixoHealth Pass app users via an encrypted QR code scan. The seamless digital connectivity shortens the wait time for the test report from days to minutes.

With the hand-held size analyzer reading test results objectively, semi-closed communities such as corporations, manufactures, schools and event organizers can minimize the risks of having false-negative cases and sustain a safe environment amidst ongoing pandemic.

A prospective clinical evaluation was conducted in Brazil with symptomatic subjects, the study reported promising accuracy of nasopharyngeal samples ¡X 94% sensitivity and 100% specificity by comparing PixoTest® with RT-PCR assay for the ranges of 0 to 7 days since symptom onset (DSO).

Another two retrospective studies of clinical performance evaluation were completed in the USA, concluding that PixoTest® POCT COVID-19 Antigen Test¡¦s accuracy meets EU standard of quality rapid antigen test. The sensitivity and specificity for nasal specimens are 92.8% and 100% respectively among symptomatic patients.

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