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OU Medicine, University of Oklahoma Health Sciences Center and Oklahoma Medical Research Foundation File for FDA Emergency Use Authorization for COVID-19 Detection Test Utilizing Fluidigm Technology

OU Medicine, the OU Health Sciences Center and the Oklahoma Medical Research Foundation collaborated to create a new test for COVID-19 using technology and reagents from Fluidigm Corporation, an innovative biotechnology tools provider. The test is intended for large-scale testing of patients across the OU Medicine healthcare system, with the capacity to test 180,000 samples over the next 90 days.

High-complexity laboratories like OU Medicine’s that are certified by CLIA (Clinical Laboratory Improvement Amendments) are eligible to create their own diagnostic test for COVID-19, according to new guidance issued by the U.S. Food and Drug Administration. OU Medicine has applied for Emergency Use Authorization for the test from the FDA.

“We are grateful for the collaboration and leadership of the researchers at OU Health Sciences Center and OMRF. This partnership with three Oklahoma healthcare leaders and Fluidigm makes it possible for OU Medicine to offer this unique testing capability to our state,” said Chuck Spicer, FACHE, President and CEO of OU Medicine, Inc. “We believe this greatly increased number of tests will serve as a turning point in our battle against the COVID-19 pandemic.

“Readily accessible and rapid testing for COVID-19 not only expedites treatment for patients who test positive, but it allows healthcare providers to be routinely tested to ensure their safety and that of everyone they encounter,” Spicer added. “Increased testing will also allow more patients without COVID-19 to access specialty care at OU Medicine, including surgeries, procedures and other diagnostic testing.”

The testing platform will produce results quickly – in about six hours – which will allow physicians to promptly begin treatment on patients who test positive, and will help public health officials gain a more accurate picture of the spread of the virus in Oklahoma.

OMRF’s experience with Fluidigm’s microfluidics technology and its Fluidigm Biomark™ HD system was a crucial component in the creation and validation of the test. The FAA Civil Aerospace Medical Institute in Oklahoma City also provided a Biomark™ HD system for use in the testing. Microfluidics technology generates more data and uses a fraction of limited testing reagents per sample compared with more traditional technology.

“Solutions that offer scale and high-speed processing are critically important in ramping up testing capabilities for COVID-19,” said OMRF President Stephen Prescott, M.D. “We anticipate that the test will generate several thousand test results per day, and it comes online at a particularly critical time for COVID-19 patients in Oklahoma.”

Rapid, high-capacity testing will continue to be critical for contact tracing – determining how many people have been exposed to an infected person. Testing will remain fully functional for as long as patients and the residents of Oklahoma need to be tested. That capability will help the state determine when and how Oklahomans can begin returning to work and their daily lives following the peak of the pandemic.

“The remarkable volume of testing made available through the tireless work of our OU Health Sciences Center researchers and partners at OU Medicine, OMRF, and Fluidigm is, simply put, game-changing,” said OU Interim President Joseph Harroz Jr. “As this innovative testing platform ramps into full capacity, we will be able to ensure Oklahoma has consistent testing for the current environment and for possible future outbreaks, as well as demographic and geographic sampling that can help contain further spread.”

Because Fluidigm technology employs a different approach than other testing platforms, OU Medicine is able to benefit from its speed and scale capabilities.

“Since the beginning of the COVID-19 outbreak, adequate resources for testing have been a serious challenge for healthcare systems around the world,” said Chris Linthwaite, President and CEO of Fluidigm. “Speed, scale and automation are critical components to delivering timely results. “We are excited to support OU Medicine, the Oklahoma Medical Research Foundation and the OU Health Sciences Center in this incredibly important program,” Linthwaite added. “In parallel with this scaling of testing capacity, Fluidigm products are providing vital information on immune response to COVID-19 exposure. This information is essential for evaluation of patient management approaches and effective vaccine and therapeutic candidate development. The COVID-19 testing program underway in Oklahoma City positions their community at the forefront of pandemic preparation efforts in the global fight against this virus.”

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

Myositis Autoantibodies: A Comparison of Serotyping Panels

Lara C. Pullen, PhD   |   December 11, 2019

Despite this uncertainty, rheumatologists use blood tests to diagnose myositis, which means, absent a positive blood test, diagnosis is difficult. The challenges of diagnosing myositis are compounded by the fact that myositis is a general term describing multiple rare diseases. Moreover, myositis patients can have distinct presentations, and the disease can evolve over time. As a result, patients may accrue signs and symptoms of disease over a year or two and may visit three or four rheumatologists before being diagnosed. Reliable antibody panels may decrease the interval from symptom onset to diagnosis.

Christopher A. Mecoli, MD a rheumatologist at the Johns Hopkins University School of Medicine, Baltimore, and colleagues compared an increasingly used line blot array, Euroimmun Autoimmune Inflammatories Myopathies 16 Antigen platform, with the Oklahoma Medical Research Foundation Myositis panel (OMRF). The OMRF autoantibody panel is considered by many myositis experts to be the clinical gold standard antibody test. It uses several different assays, such as immunodiffusion, indirect immunofluorescence, immunoprecipitation of 35 S-methionine-labeled proteins from cell extracts and RNA-immunoprecipitation to read out antibodies. The OMRF panel tests for autoantibodies recognizing Jo-1, Mi2, SRP, PM/Scl, PL-7, PL-12, Ku, EJ and OJ. The Euroimmun platform is a research assay and tests for Mi2α, Mi2β, PM/Scl75, PM/Scl100, Ku, Jo-1, SRP, PL-7, PL-12, EJ, OJ, TIF1γ, MDA-5, NXP-2, SAE and Ro52.

The rheumatologists at Johns Hopkins regularly review clinical data in parallel with research data to identify patterns in discordant results. In this study, the researchers analyzed serum samples (N=281) from The Johns Hopkins Myositis Cohort, a prospective myositis cohort of patients with autoimmune myositis. The results of the study were published online Aug. 20 in Arthritis & Rheumatology . 1

The investigators used both OMRF and Euroimmun assays to test the blood sample from each patient. Approximately, one third of the samples tested positive by OMRF. Using the Euroimmun standard positive cutoff of greater than 15, approximately half of the samples tested positive for at least one antibody on the Euroimmun panel. Thus, some patients (n=18) were positive according to the Euroimmun assay, but negative according to OMRF.

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As OMRF hits 75-year milestone, here are 5 of its scientists' key discoveries

Saturday marks the 75th anniversary of the Oklahoma Medical Research Foundation. 

In that time, the foundation’s researchers have made discoveries that paved the way for new life-saving drugs and made strides in studying autoimmune diseases, cardiovascular disease and diseases of aging. 

After OMRF was chartered on Aug. 28, 1946, more than 7,000 Oklahomans donated over $2 million to the new effort, and construction of its campus began in 1949.

The foundation began with 18 scientists on staff. Now, it has a staff of 450 devoted to studying a number of diseases, including Alzheimer’s, lupus and cancer. 

When Sir Alexander Fleming, known for his discovery of penicillin, spoke in 1949 at OMRF’s dedication ceremony, he said the new foundation’s work “may prove a thousand times more valuable to humanity than all the oil in Oklahoma.”

“Now, that's a really lofty charge,” said Adam Cohen, OMRF’s interim president. “But when I look over the sweep of the last 75 years, and I think of all of the contributions, not only to understanding, but to tangible treatments for disease that have changed and saved patients’ lives, it really is profound.” 

While the list of OMRF discoveries is a long one, Cohen shared a few highlights of the foundation’s 75-year history:

3 life-changing drugs

OMRF discoveries have paved the way for drugs that have changed the lives of scores of patients, Cohen said.

Most recently, in 2019, the federal Food and Drug Administration approved the first targeted therapy to treat sickle cell disease.

The drug, Adakveo, is based on discoveries from OMRF’s Dr. Rodger McEver.

“I’ve treated sickle cell patients, and their suffering is extreme,” McEver said at the time the drug was cleared for use. “It’s the dream of every physician, and certainly every scientist, to do something that can make a difference with patients.”

Before that, OMRF scientists Dr. Peter Sims and Dr. Therese Wiedmer made discoveries that led to the development of the drug Soliris. The drug is used to treat a rare blood disorder: paroxysmal nocturnal hemoglobinuria, or PNH, which can be fatal.

After first being approved to treat PNH in 2007, Soliris was green-lighted in 2019 by the FDA for treating patients with neuromyelitis optica, which OMRF describes as a “rare, debilitating cousin of multiple sclerosis.”

Discoveries in the 1980s from a husband-and-wife pair of OMRF scientists, Drs. Charles and Naomi Esmon, led to the creation of the drug Ceprotin, which is used to treat people with a rare, life-threatening deficiency of Protein C in their blood.

“When he and Naomi first came here, they spent lots and lots of time down at the stockyards collecting 10-gallon vats of blood from the animals who were being slaughtered,” Cohen said. "They used this to do so many basic experiments through the years, and those insights, ultimately, gave birth to this drug that is now being used in clinics around the world.”

Researchers’ work on lupus 

OMRF scientists have made major strides in understanding lupus, a chronic autoimmune disease in which the body attacks its own tissues and organs. 

A team of OMRF researchers published findings in 2003 that most patients who develop lupus have proteins in their blood called autoantibodies years before they show symptoms. 

The discovery was a sort of “crystal ball” for lupus, the foundation described it in its magazine’s 75th anniversary edition.

OMRF scientists have also identified or confirmed more than 60 genes that have now been linked to lupus, Cohen said. The foundation has also established the largest repository in the world of biological samples from lupus patients and their families. 

“These samples have spawned hundreds and hundreds of research studies around the world that have pushed our knowledge of the disease forward significantly,” Cohen said. 

That work, Cohen said, is part of what led the National Institutes of Health to designate OMRF one of 10 Autoimmunity Centers of Excellence.

The work of Dr. Jordan Tang

Dr. Jordan Tang, an OMRF scientist who was with the foundation for more than half a century, was the first scientist inducted into the Oklahoma Hall of Fame. 

Tang, who died last year, had a breakthrough early in his career: he discovered a stomach enzyme no one else had before. He spent years learning its structure and found that the enzyme was a type of cutting protein called a protease.

“He then devoted the rest of his career to following these proteases in the body,” Cohen said. 

That led to discoveries that helped fuel the creation of protease-inhibitor drugs, which added years to the lives of people with HIV and AIDs, Cohen said. And his work led to key insights into Alzheimer’s disease, too.

Tang’s body of work “is absolutely a greatest hit for OMRF,” Cohen said. 

Now, as OMRF looks to the next 75 years, Cohen said he hopes the work the foundation’s scientists are doing now will be a “keystone for future discoveries.” 

“We have consistently taken the discoveries that happen in our labs and transform them into treatments that have touched the lives of people everywhere,” he said. "As we look forward, my profound hope is that we continue to be impactful — that we continue to touch lives because that, to me, is the measure of the institution's value.” 

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OU Medicine, University of Oklahoma Health Sciences Center and Oklahoma Medical Research Foundation File for FDA Emergency Use Authorization for COVID-19 Detection Test Utilizing Fluidigm Technology

OU Medicine, the OU Health Sciences Center and the Oklahoma Medical Research Foundation collaborated to create a new test for COVID-19 using technology and reagents from Fluidigm Corporation, an innovative biotechnology tools provider. The test is intended for large-scale testing of patients across the OU Medicine healthcare system, with the capacity to test 180,000 samples over the next 90 days.

High-complexity laboratories like OU Medicine’s that are certified by CLIA (Clinical Laboratory Improvement Amendments) are eligible to create their own diagnostic test for COVID-19, according to new guidance issued by the U.S. Food and Drug Administration. OU Medicine has applied for Emergency Use Authorization for the test from the FDA.

“We are grateful for the collaboration and leadership of the researchers at OU Health Sciences Center and OMRF. This partnership with three Oklahoma healthcare leaders and Fluidigm makes it possible for OU Medicine to offer this unique testing capability to our state,” said Chuck Spicer, FACHE, President and CEO of OU Medicine, Inc. “We believe this greatly increased number of tests will serve as a turning point in our battle against the COVID-19 pandemic.

“Readily accessible and rapid testing for COVID-19 not only expedites treatment for patients who test positive, but it allows healthcare providers to be routinely tested to ensure their safety and that of everyone they encounter,” Spicer added. “Increased testing will also allow more patients without COVID-19 to access specialty care at OU Medicine, including surgeries, procedures and other diagnostic testing.”

The testing platform will produce results quickly – in about six hours – which will allow physicians to promptly begin treatment on patients who test positive, and will help public health officials gain a more accurate picture of the spread of the virus in Oklahoma.

OMRF’s experience with Fluidigm’s microfluidics technology and its Fluidigm Biomark™ HD system was a crucial component in the creation and validation of the test. The FAA Civil Aerospace Medical Institute in Oklahoma City also provided a Biomark™ HD system for use in the testing. Microfluidics technology generates more data and uses a fraction of limited testing reagents per sample compared with more traditional technology.

“Solutions that offer scale and high-speed processing are critically important in ramping up testing capabilities for COVID-19,” said OMRF President Stephen Prescott, M.D. “We anticipate that the test will generate several thousand test results per day, and it comes online at a particularly critical time for COVID-19 patients in Oklahoma.”

Rapid, high-capacity testing will continue to be critical for contact tracing – determining how many people have been exposed to an infected person. Testing will remain fully functional for as long as patients and the residents of Oklahoma need to be tested. That capability will help the state determine when and how Oklahomans can begin returning to work and their daily lives following the peak of the pandemic.

“The remarkable volume of testing made available through the tireless work of our OU Health Sciences Center researchers and partners at OU Medicine, OMRF, and Fluidigm is, simply put, game-changing,” said OU Interim President Joseph Harroz Jr. “As this innovative testing platform ramps into full capacity, we will be able to ensure Oklahoma has consistent testing for the current environment and for possible future outbreaks, as well as demographic and geographic sampling that can help contain further spread.”

Because Fluidigm technology employs a different approach than other testing platforms, OU Medicine is able to benefit from its speed and scale capabilities.

“Since the beginning of the COVID-19 outbreak, adequate resources for testing have been a serious challenge for healthcare systems around the world,” said Chris Linthwaite, President and CEO of Fluidigm. “Speed, scale and automation are critical components to delivering timely results. “We are excited to support OU Medicine, the Oklahoma Medical Research Foundation and the OU Health Sciences Center in this incredibly important program,” Linthwaite added. “In parallel with this scaling of testing capacity, Fluidigm products are providing vital information on immune response to COVID-19 exposure. This information is essential for evaluation of patient management approaches and effective vaccine and therapeutic candidate development. The COVID-19 testing program underway in Oklahoma City positions their community at the forefront of pandemic preparation efforts in the global fight against this virus.”