Elecsys Anti-SARS-CoV-2 antibody test from Roche gets Early Use Approval from the U.S. Food and Drug Administration
… Elecsys Anti-SARS-CoV-2 Antibody Test Earns FDA Emergency Use Approval …

Roche Escalating COVID-19 Test Production

World’s largest in-vitro diagnostics company earns FDA Emergency Use Authorization for Elecsys Anti-SARS-CoV-2 antibody test

John G. Baresky

Roche has communicated its diagnostics business unit is accelerating the production of its Elecsys Anti-SARS-CoV-2 antibody test to come to the aid of U.S. and world markets. The company has shared the news that the U.S. Food and Drug Administration (FDA) has issued it an Emergency Use Authorization (EUA) for the diagnostic product.

Roche has ample clinical, commercial and manufacturing talent to orchestrate such a large scale undertaking

As the global leader of in-vitro diagnostics (IVD), Roche has decades of experience and vast manufacturing resources. They are already shipping substantial volumes of the product to select global markets where it has been approved for use and is moving monthly manufacturing volume goals deep into double-digit millions.

Elecsys Anti-SAR-CoV-2 test demonstrates high-performance accuracy

The Elecsys Anti-SARS-CoV-2 antibody test is highly coveted due to its precise accuracy. The product’s accuracy rate is greater than 99.8%. Through a blood sample, it can detect antibodies to the new coronavirus causing COVID-19. The test can determine if a patient has been exposed to COVID-19 and if they have produced antibodies against it.

EUA status enables Roche to move faster so the Elecsys Anti-SARS-CoV-2 antibody test is available to more persons in the U.S. sooner

A EUA allows unapproved medical products or unapproved uses of approved medical products to be used in emergency events. This may include diagnosis, treatment or prevention of serious diseases or other human health conditions.

These can be triggered by biological, chemical, radiological, nuclear or other catastrophic threats. In such highly unusual and typically spontaneous events, there may not be existing approved resources immediately available nor adequate time to go through the standard rigor of a full approval process.

Given the urgency of the matters at hand, EUA’s are based on an intense review conducted by the FDA plus a close collaboration between them and the organization applying for EUA status. The EUA does not signify the complete approval of a product. Once sufficient time has passed, such products or their uses are required to fulfill the normal approval requirements the FDA specifies if they wish to remain in use in U.S. markets.

The circumstances involving the World Health Organization (WHO) and COVID-19’s Public Health Emergency of International Concern (PHEIC) designation are an ideal example of when EUA’s are deployed.

Roche a global leader in diagnostics and pharmaceuticals

Based in Basel, Switzerland, Roche (Swiss Exchange: ROG-CH OTCQX: RHHBY) was founded in 1896. It generated almost $64 billion in sales during 2019. It has numerous divisions; their biotech and pharmaceutical business enterprises include Chugai and Genentech.

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