COVID-19 Testing Labs Can Skip RNA Extraction, Simplifying and Accelerating Workflow, With New Promega XpressAmp� Direct Amplification Reagents

MADISON, Wis.–(BUSINESS WIRE)–Laboratories testing for COVID-19 have a new tool that enables them to skip the potentially bottlenecked RNA extraction step of the workflow and move directly to polymerase chain reaction (PCR) amplification. Promega Corporation today released XpressAmp� Direct Amplification Reagents that facilitate RNA extraction-free sample preparation that is automation-friendly.

The simple, direct amplification workflow involves:

1. Collect and store sample – use common nasopharyngeal swabs in transport media
2. Lyse sample – mix sample and XpressAmp™ Lysis Buffer (1:1) and incubate for 10 minutes at room temperature
3. Amplify and analyze – add lysed sample to RT-qPCR containing XpressAmp™ Solution

Promega, a global manufacturer of reagents, assays and benchtop instruments essential for COVID-19 research, drug development and diagnostic testing, including RNA extraction, increased production dramatically since the start of the pandemic to address a 10-fold increase in demand. Reagent manufacturers worldwide responded similarly. Still, supply and demand gaps remain, particularly around RNA extraction. Promega sought a solution that leverages the company’s more than 40 years of experience in both sample preparation and amplification, especially its work with challenging samples such as forensic crime scene evidence. The result is a direct amplification method that simplifies and accelerates time to qPCR results.

“We are constantly exploring ways to apply our scientific and manufacturing expertise to help labs address the unprecedented demands they are facing for COVID-19 testing,” says Promega Chief Medical Officer Ashley Anderson. “Offering an option to skip RNA extraction and move directly to PCR amplification not only saves time, it also addresses potential supply constraints since the many buffers and optimization reagents needed for extraction and wash steps in a typical PCR workflow are no longer needed.”

XpressAmp™ Direct Amplification Reagents are a custom product that can be adjusted in numerous ways to suit a laboratory’s specific needs. Options include purchasing in bulk, changing the dispense size or reformatting and relabeling.

Direct amplification technology continues Promega Corporation’s support of the worldwide fight against COVID-19.

• Since January, the company has provided enough reagents and enzymes to enable testing an estimated 350.5 million samples for SARS-CoV-2 worldwide. Promega components currently support approximately 29 COVID-19 test kits around the world.
• The Promega GoTaq® Probe 1-Step RT-qPCR System, the Maxwell® RSC 48 Instrument and the Maxwell® RSC Viral Total Nucleic Acid Purification Kit are all authorized products in the Centers for Disease Control and Prevention’s 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel for emergency use.
• Promega has applied to the U.S. Food and Drug Administration for an emergency use authorization (EUA) for its new Lumit™ Dx SARS-CoV-2 Immunoassay serological antibody test.

Promega 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 tools are used for a myriad of applications in human health, disease, genetic identity, drug development, clinical diagnostics and more.

To learn more about Promega XpressAmp™ Direct Amplification Reagents, visit www.promega.com/PromegaXpressAmp

About Promega Corporation

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.

Contacts

Penny Patterson

VP, Communications

Promega Corporation

Phone: (608) 274-4330

E-mail: penny.patterson@promega.com