Emergency Use Authorization: The What, the Why and the How

This blog is written by guest blogger, Heather Tomlinson, Director of Clinical Diagnostics at Promega.

Finding safe and effective treatments for human diseases takes time.  Medication and diagnostic tests can take decades to discover, develop and prove safe and effective.  In the United States, the FDA stands as the gold-standard gatekeeper to ensure that treatments and tests are reliable and safe. The time we wait in review and clearance means less risk of ineffective or unsafe treatments.

And yet, in a pandemic, we are behind before we even start the race to develop diagnostic tests, so critical for understanding how an infectious disease is spreading. That is when processes like the FDA’s fast track of Emergency Use Authorization (EUA) are critical. Such authorization allows scientists and clinicians to be nimble and provide the best possible test protocol as quickly as possible, with the understanding that these protocols will continue to be evaluated and improved as new information becomes available. The EUA focuses resources and accelerates reviews that keep science at the fore and gets us our best chance at staying safe and healing.

The Maxwell 48 RSC Instrument and the Maxwell RSC Total Viral Nucleic Acid Isolation Kit are now listed as options within the CDC EUA protocol.

For scientists working around the clock, the FDA’s EUA process is ready to review and respond. Getting an EUA  gives clinical labs a very specific and tested resource to guide them to the tools and tests to use in a crisis.

Typically the Centers for Disease Control (CDC) will develop the first test or protocol that receives FDA EUA in response to a crisis like a pandemic.  For COVID-19 the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel received FDA EUA clearance in early February. This is the test protocol used by the public health labs that work with the CDC and test manufacturers around the world.

Throughout a crisis such as the current pandemic, scientists continually work to improve the testing protocols and add options to the EUA protocols. This enables more flexibility in the test protocols. Promega is fortunate to play a part of the CDC EUA equation for diagnostic testing. Our GoTaq® Probe 1-Step PRT-qPCR System is one of a few approved options for master mixes in the  CDC qPCR diagnostic test,  and now our medium-throughput Maxwell 48 Instrument and Maxwell Viral Total Nucleic Acid Purification Kit  have been added to the CDC protocol as an option for the RNA isolation step as well. These additions to the CDC EUA means that laboratories have more resources at their disposal for the diagnostic testing which is so critical to effective pandemic response.

The Emergency Use Authorization provides the FDA guidance to strengthen our nation’s public health during emergencies, such as the current COVID-19 pandemic. The EUA allows continual improvement of an authorized protocol through the collaborative efforts scientists in all academia, government and industry to identify and qualify the most reliable technologies and systems, giving labs more flexibility as new products are added as options.

Dr. Tomlinson is the Director for the Global Clinical Diagnostics Strategic Business Unit at Promega Corporation with over 15 years of experience in clinical diagnostic test development. She is responsible for leading the team that drives strategy in the clinical market for Promega. Her background is in infectious disease diagnostic testing, with a focus on HIV drug resistance and evolution.  Her recent work has been in oncology companion diagnostic test development.  Heather has is an accomplished international presenter, delivering conference presentations in the United States, Europe, Asia, and Africa.

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Promega Leverages Long-Time Experience in MSI Detection with European Launch of CE-Marked IVD Assay for Microsatellite Instability

The genetic abnormality called microsatellite instability, or MSI, has been linked to cancer since its discovery in 1993 (1). MSI is the accumulation of insertion or deletion errors at microsatellite repeat sequences in cancer cells and results from a functional deficiency within one or more major DNA mismatch repair proteins (dMMR).  This deficiency, and the resulting genetic instability, is closely related to the carcinogenicity of tumors (2).

Historically MSI has been used to screen for Lynch Syndrome, a dominant hereditary cancer propensity. More recently, tumors with deficient MMR function have been identified as being more likely to respond to immune checkpoint inhibitor (ICI) therapies (3.). Because MSI can be the first evidence of an MMR deficiency, MSI-High status is predictive of a positive response to immunotherapies such as ICI therapies. (3).

Learn more about MSI in this short animation.
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Wisconsin’s Public-Private Partnership to Increase COVID-19 Testing Capacity

This blog is written by Sara Mann, General Manger, Promega North America Branch

Promega is part of a new public-private partnership among Wisconsin industry leaders to increase the state’s laboratory testing capacity for COVID-19. I am pleased to represent Promega in this effort. The valuable insight we at Promega are gaining every day through our participation in this innovative partnership not only benefits Wisconsin labs, it also provides unique understandings about how we can best meet the testing needs of our customers around the world.

Promega Maxwell Instrument shown in a laboratory.

The new partnership includes laboratory support from Exact Sciences, Marshfield Clinic Health System, UW Health, as well as Promega. These organizations, along with the Wisconsin Clinical Lab Network, are sharing knowledge, resources, and technology to bolster Wisconsin’s testing capacity. Our goal is to help labs find the quickest approach to the most tests with their validated methods.

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Meeting Customer Needs in Response to Market Dynamics: Responding to the Coronavirus Pandemic

Today’s blog is written by Chuck York, VP of Manufacturing Operations at Promega.

Coronavirus SARS-2-CoV continues to fuel unprecedented demand for COVID-19 related products. Once a term relegated to virology research labs, “coronavirus” is now a household term and a global crisis that has upended lives, disrupted entire economies and shaken our sense of normalcy.

Clinicians, researchers, government officials and the general public are understandably concerned about the availability of reagents for coronavirus testing. At Promega, we are hearing the needs and concerns of our scientific colleagues and partners, and we are doing all that we can to help alleviate them.

At Promega, we are hearing the needs and concerns of our scientific colleagues and partners, and we are doing all that we can to help alleviate them.

As a global company with thousands of products, we have been meeting customer demand in response to market dynamics for decades. Our long-term approach has served customers well. Our efforts to provide support for the COVID-19 response began in early January, with our work with our colleagues and customers in China. We are applying what we’ve learned to propel us forward in the most efficient way now.  

We continue to increase production of all COVID-19 related reagents and instruments due to an unprecedented increase in global demand. Production lines that were running one shift 5 days a week are now operating 3 shifts seven days a week, and we continue to take measures to increase our manufacturing capacity.

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The Art of Being a Field Scientist

Today’s article is written by guest blogger Vince Debes, this year’s winner of the Promega Art Contest for Creative Scientists. He will be starting a Master of Science program in Geological Sciences in the School of Earth and Space Exploration at Arizona State University this fall.

Grand Tetons at night

It’s incredible how seemingly insignificant actions can lead to major events years down the road. When my partner and I were testing out our new camera shutter remotes in the Grand Tetons on the way to do field work in Yellowstone, I never imagined an image we captured would lead to a grand prize in the Promega Art Contest for Creative Scientists. The four-minute-long exposure was taken at midnight with a full moon and shows the ghostly, almost imperceptible, movements of Colter Bay marina vessels against a backdrop of trailing stars and the stolid Tetons.

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Rapid Test to Detect SARS-2-CoV Developed in Brazil

The Virology lab at the Universidade Federal da Bahia (UFBA), led by Dr. Gúbio Soares, has developed a fast and specific real-time PCR assay using GoTaq 1-Step RT-qPCR for detection of SARS-2-CoV (the coronavirus previously named 2019-nCoV), which causes the respiratory disease COVID-19. The Maxwell RSC instrument is used for automated extraction of RNA from oral-pharyngeal secretion collected by swab or bronchial wash prior to the assay. This coronavirus-specific assay can shorten the time to identify SARS-2-CoV from 48 hours to 3 hours (1), providing critical information to public health officials in a timely fashion.

“Promega has been providing all our reagents for standard and real-time PCR and also for nucleic acid extraction. It’s a company I can rely on the relationship; they are our partners and have provided excellent support both technically and financially. Promega is the base of all our assays.” Dr. Gúbio Soares.  

Dr. Soares’ laboratory has experience developing assays to identify and detect emerging viral pathogens. Their laboratory first identified the Zika virus as the etiologic agent in the large outbreaks of acute exanthematous illness (AEI) in northeast Brazil in April 2015 (2). Zika was eventually declared a public health emergency of international importance by the World Health Organization in February 2016, after increased incidence of microcephaly was detected in the infants of women infected during pregnancy. Many of the lessons learned in the management of the Zika crisis are informing how scientists are addressing SARS-2-CoV. The Zika response was characterized by a collaborative spirit to share data, samples and resources among scientific labs across the globe.

Below is a video link from Brazil (audio in Portuguese) describing Dr. Soares’ group work on SARS-2-CoV. https://globoplay.globo.com/v/8302334/

Sources Cited

  1. TV Bahia (2020) Test developed at UFBA can identify coronavirus in 3 hours, says researcher. [Internet: https://g1.globo.com/ba/bahia/noticia/2020/02/07/teste-desenvolvido-na-ufba-pode-identificar-coronavirus-em-3h-diz-pesquisador.ghtml Accessed: February 19, 2020]
  2. Sandler, N. (2016) Zika: Personal Perspectives, Global Responses Promega Corporation. [Internet: https://www.promega.com/Resources/PubHub/Inspiration/Zika%20Perspectives%20Responses/ Accessed : February 19, 2020]

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New Year, New Buildings, Same Commitment to Sustainability

In times of rapid growth, we look to the future with excitement while also assuring that our expansion is sustainable. The Promega Global Facilities Planning Team emphasizes environmental stewardship and long-term planning. Each building is designed to meet ambitious sustainability goals, and innovations incorporated into each project inform the next. In 2019, we finished construction on two new buildings in Europe and made progress on two important facilities at our headquarters in Wisconsin.

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Sustainability Makeover: Parking Ramp Edition

parking_ramp_solar_panels

As Promega grows globally and locally here at headquarters, the construction of new and expanding facilities are considered with great care to ensure a commitment to sustainability. Between April and November of 2019, the parking ramp located near the Feynman Center received a massive upgrade with long-term impacts on the company’s sustainability goals.

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Learnings From the Eppendorf Exchange Program

Last year, on Promega’s 40th anniversary, we received a generous gift from a friend in the industry: Eppendorf. That gift was an exchange program. The teenage child of any Promega employee was given the opportunity to visit an Eppendorf family in another country, and in return host the Eppendorf family’s child in their home. The goal was for both children to experience another culture and build a relationship with each other.

In 2019, 11 Promega children bid good-bye to their parents, hopped on a plane, and flew to Germany. There they would stay for three weeks with a family they’ve never met. For all involved, it proved to be a valuable and positive learning opportunity. Here are a few takeaways from their experience:

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CRISPR/Cas9 Knock-In Tagging: Simplifying the Study of Endogenous Biology

Understanding the expression, function and dynamics of proteins in their native environment is a fundamental goal that’s common to diverse aspects of molecular and cell biology. To study a protein, it must first be labeled—either directly or indirectly—with a “tag” that allows specific and sensitive detection.

Using a labeled antibody to the protein of interest is a common method to study native proteins. However, antibody-based assays, such as ELISAs and Western blots, are not suitable for use in live cells. These techniques are also limited by throughput and sensitivity. Further, suitable antibodies may not be available for the target protein of interest.

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