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QIAGEN (QGEN) Digital COVID-19 Antibody Test Gets FDA's EUA

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QIAGEN N.V. QGEN recently announced the receipt of the FDA’s Emergency Use Authorization (EUA) for the fast and easy-to-use digital QIAreach Anti-SARS-CoV-2 Total Test. With the U.S. authorization, QIAGEN can start making its portable antibody testing device available to healthcare professionals which helps in monitoring immune status in relation to COVID-19.

For investors’ note, QIAGEN developed the QIAreach Anti-SARS-CoV-2 Total Test in partnership with an Australian digital diagnostics company – Ellume.

The authorization of the digital test will fortify QIAGEN’s expanding portfolio of COVID-19 testing solutions.

More on QIAreach Anti-SARS-CoV-2 Total Test

The QIAreach Anti-SARS-CoV-2 Total Test detects total antibodies (Total immunoglobulin) specific to SARS-CoV-2 immune response unlike other tests that identify only selected antibodies.

The antibody test takes nearly 10 minutes to detect whether a person carries antibodies to the SARS-CoV-2 virus as a result of prior infection.

Further, the test results are available on a digital eHub device that can handle eight tests at a time, all working independently and can process up to 32 samples per hour.

Significance of the Authorization

The QIAreach Anti-SARS-CoV-2 Total Test is serological and can be used to identify people who have been recently infected by the virus, particularly those who did not show any symptoms and therefore might not know of an infection.

Per management of QIAGEN, understanding the COVID-19 immunity in a population can help guide public health measures as societies are now returning to normal routines.

Recent Developments

In April 2021, QIAGEN launched QIAseq DIRECT SARS-CoV-2 Kit. The kit significantly lessens hands-on time, requires no fragmentation or ligation reactions and can be easily automated with robotic liquid handlers. Further, the viral enrichment approach delivers improved coverage uniformity across the SARS-CoV-2 genome as well as deeper sequencing performance unlike the most widely used amplicon-based options.

During the same month, QIAGEN launched artus SARS-CoV-2 Prep&Amp UM Kit which uses a liquid-based sample preparation technology to simplify and increase COVID-19 testing throughput. The kit uses Universal Transport Media as the starting material and provides all reagents required for sample to result on suspected SARS-CoV-2 patient samples.

Industry Prospects

Per a report by Grand View Research, the global COVID-19 diagnostics market size was $84.4 billion in 2020 and is expected to reach $104.7 billion by 2027, at a CAGR of 3.1%.

Recent Developments by Peers in COVID-19 Testing

QIAGEN is facing tough competition in the field of COVID-19 testing space from companies like Quest Diagnostics DGX, Abbott ABT and LabCorp LH.

In May 2021, Quest Diagnostics announced collaboration with Ginkgo Bioworks to provide COVID-19 testing services for Senior (K-12) school to support classroom learning nationwide. Under the program, school administrators can implement a testing program that tests students, teachers and staff using pooled specimens.

In April 2021, Abbott Laboratories’ BinaxNOW COVID-19 Ag Self Test got FDA’s EUA clearance for over-the-counter, non-prescription and asymptomatic use. With this regulatory go-ahead, individuals with or without symptoms can have over-the-counter access to this rapid antigen self-test.

The same month, LabCorp announced the availability of the Pixel by Labcorp COVID-19 PCR Test-Home Collection Kit for small businesses. The kit is aimed at providing fast, convenient, and reliable testing for companies with as many as 120 employees. The availability of test kit by QIAGEN for small business makes it easier than ever for restaurants, production companies, retailers, and other small businesses to safely operate in their local communities.

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Quest Diagnostics Incorporated (DGX) : Free Stock Analysis Report
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