SARS-CoV-2 Antibody Test Developed by Promega Receives CE Mark

Novel bioluminescent Lumit™ Dx SARS-CoV-2 Immunoassay enables simple, scalable antibody detection

MADISON, Wis.--(BUSINESS WIRE)--A SARS-CoV-2 antibody test developed by Promega Corporation, the Lumit™ Dx SARS-CoV-2 Immunoassay, has received CE marking and is now available in Europe. The novel bioluminescent immunoassay is a qualitative in vitro diagnostic test intended to detect antibodies to SARS-CoV-2 in serum.

Promega designed the Lumit™ Dx SARS-CoV-2 Immunoassay to be reliable, simple and scalable, enabling labs to:

• Detect antibodies against the receptor-binding domain (RBD) antigen within the SARS-CoV-2 spike (S) protein in serum in less than one hour at room temperature.
• Conserve resources with a simple add-incubate-read workflow with no wash steps.
• Accelerate testing of large patient populations by adapting the assay to high throughput on many automated platforms.

The assay leverages Promega NanoBiT^® bioluminescence complementation technology to emit a measurable glowing signal when SARS-CoV-2 antibodies are present. NanoBiT^® technology has received awards from The Scientist and the European Laboratory Research and Innovation Group.

“Bioluminescence, when applied to antibody detection, offers laboratories several advantages including a simple and fast workflow,” says Promega Chief Medical Officer Ashley Anderson, MD.

The Lumit™ Dx SARS-CoV-2 Immunoassay is also available in the US under a policy allowing developers of serological tests to make them available while awaiting US Food and Drug Administration (FDA) review.

Promega COVID-19 Support

Promega reagents, assays and benchtop instruments are being used around the world for COVID-19 testing, research, and vaccine development.

• Reagents to enable testing an estimated 800 million samples: Since January 2020, Promega has rapidly increased production to support labs testing for SARS-CoV-2 worldwide.
• Products in the US Centers for Disease Control (CDC) Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay for emergency use: Maxwell^® RSC 48 and CSC 48 instruments; Maxwell^® RSC Viral Total Nucleic Acid Purification Kit
• Products in the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel for emergency use: GoTaq^® Probe 1-Step RT-qPCR System; Maxwell^® RSC 48 and CSC 48 instruments; Maxwell^® RSC Viral Total Nucleic Acid Purification Kit

• Technology to accelerate COVID-19 testing: XpressAmp™ Direct Amplification Reagents allow labs to skip the RNA extraction step of the workflow.

Tools used for COVID-19 applications are a small subset of the 4,000 products Promega manufactures and distributes globally, serving research, pharma, clinical, forensic and applied markets. These products are used for a myriad of applications in human health, disease, genetic identity, drug development, clinical diagnostics and more.

Learn more about the Lumit™ Dx SARS-CoV-2 Immunoassay at: www.promega.com/antibody

About Promega

Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s product portfolio of over 4,000 products support a range of life science work across areas such as cell biology; DNA, RNA and protein analysis; drug development; human identification and molecular diagnostics. For over 40 years these tools and technologies have grown in their application and are used today by scientists and technicians in labs for academic and government research, forensics, pharmaceuticals, clinical diagnostics and agricultural and environmental testing. Promega is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. For more information, visit www.promega.com