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Precision Biosensor’s COVID-19 rapid antigen test received CE mark!
2020-09-21

Precision Biosensor, an in vitro Diagnostics (IVD) company, announced today that, in addition to two COVID-19 antibody tests (Gold & TRF), it had now achieved CE mark for its COVID-19 antigen test. After receiving CE mark in last July, antibody tests have been in market for sale in Europe, Asia and Middle East countries.

 

 

Precision Biosensor COVID-19 Line-ups

 

 

Exdia COVID-19 Ag is an antigen PoCT (Point-of-care Testing) that can diagnose COVID-19 infection within 20 minutes using antigen-antibody reactions.

 

From July, Precision Biosensor has been accelerating the research to develop high-sensitivity COVID-19 antigen diagnostic test by signing a technology transfer agreement with Korea Research Institute of Chemical Technology Center for Convergent Research of Emerging Virus Infection (CEVI). By successfully obtaining CE mark for this test, Precision Biosensor has verified its ability to develop and launch products in a short term.

 

Using Exdia TRF, a high-sensitivity fluorescence diagnostics platform, Precision Biosensor can diagnose COVID-19 and Influenza A+B, making it ready for the double epidemic outbreak of flu and COVID-19 this winter, which infectious disease experts are concerned about.

 

Apart from Influenza A+B, COVID-19 antibody tests and COVID-19 antigen test, Precision Biosensor is diversifying its infectious disease line-ups by adding MERS (Middle East Respiratory Syndrome) test which was previously licensed-in from Korea Basic Science Institute (KBSI).

 

 

Clinical Performance of COVID-19 Line-ups

 

1)Exdia COVID-19 Ag

 

- Clinical Performance

 

 

 

2) Exdia COVID-19 IgG/IgM

 

 

- Clinical Performance

 

 

3) PBCheck COVID-19 IgG/IgM

 

 

- Clinical Performance 

 

 

 

Contact for more information or inquiries:

info@precision-bio.com