Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

[Maestro]

Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

1 September 2020

 

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA).

The SARS-CoV-2 Rapid Antigen Test is for use in point of care settings for both symptomatic and asymptomatic people. This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes.¹ In addition, it serves as a valuable initial screening test for individuals that have been exposed to SARS-CoV-2 infected patients or a high risk environment.The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers.* At launch, there will be 40 million SARS-CoV-2 Rapid Tests available, per month. This capacity will increase more than two-fold at the end of this year to help with testing demands of healthcare systems globally.

 

Read more: https://www.roche.com/media/releases/med-cor-2020-09-01b.htm

[Maestro]

2 minutes ago, Maestro said:

...for markets accepting the CE Mark...

 

About CE marking and the counties requiring it, see here:

 

https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm

Excerpt:

Quote

Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.

 

[DrTuner]

These are coming now, Abbott also announced 5$, 15min test:

https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month

 

A very useful tool but still requires tracing & isolation as part of the complete strategy. These should help the travel industry a bit, except in countries (read Thailand) where some boneheaded usurpers have scared the populace <deleted>less and are ready to destroy the economy.

[thaicookingchef]

On 9/2/2020 at 2:19 PM, Maestro said:

Roche to launch SARS-CoV-2 Rapid Antigen Test in countries accepting CE mark, allowing fast triage decisions at point of care

1 September 2020

 

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will launch a SARS-CoV-2 Rapid Antigen Test, in late September, for markets accepting the CE Mark. Roche also intends to file for Emergency Use Authorisation (EUA) to the U.S. Food and Drug Administration (FDA).

The SARS-CoV-2 Rapid Antigen Test is for use in point of care settings for both symptomatic and asymptomatic people. This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes.¹ In addition, it serves as a valuable initial screening test for individuals that have been exposed to SARS-CoV-2 infected patients or a high risk environment.The test has a sensitivity of 96.52% and a specificity of 99.68%, based on 426 samples from two independent study centers.* At launch, there will be 40 million SARS-CoV-2 Rapid Tests available, per month. This capacity will increase more than two-fold at the end of this year to help with testing demands of healthcare systems globally.

 

Read more: https://www.roche.com/media/releases/med-cor-2020-09-01b.htm

 

 

They are available in Korea since June, but not yet in Thailand it seems ?