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UrduHigh-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.”
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Editor’s Note: Testing announcement: https:/
Testing lab B-roll: https:/
About OU Medicine
OU Medicine–along with its academic partner, the University of Oklahoma Health Sciences Center–is the state’s only comprehensive academic health system of hospitals, clinics, and centers of excellence. With 11,000 employees and more than 1,300 physicians and advanced practice providers, OU Medicine is home to Oklahoma’s largest physician network with a complete range of specialty care. OU Medicine serves Oklahoma and the region with the state’s only freestanding children’s hospital, the only National Cancer Institute-Designated Stephenson Cancer Center, and Oklahoma’s flagship hospital, which serves as the state’s only Level 1 trauma center. OU Medicine is the No. 1 ranked hospital system in Oklahoma, and its oncology program at Stephenson Cancer Center and OU Medical Center ranked in the Top 50 in the nation, in the 2019-2020 rankings released by U.S. News & World Report. OU Medicine was also ranked by U.S. News & World Report as high-performing in four specialties: Ophthalmology in partnership with Dean McGee Eye Institute, Colon Surgery, COPD, and Congestive Heart Failure. OU Medicine’s mission is to lead health care in patient care, education, and research. To learn more, visit oumedicine.com.
About the University of Oklahoma
Founded in 1890, the University of Oklahoma is a public research university located in Norman, Oklahoma. OU serves the educational, cultural, economic, and health care needs of the state, region, and nation. For more information visit ou.edu.
About Oklahoma Medical Research Foundation
OMRF (omrf.org) is an independent, nonprofit biomedical research institute dedicated to understanding and developing more effective treatments for human diseases. Its scientists focus on such critical research areas as cancer, diseases of aging, lupus, and cardiovascular disease.
About Fluidigm
Fluidigm (Nasdaq:FLDM) focuses on the most pressing needs in translational and clinical research, including cancer, immunology, and immunotherapy. Using proprietary CyTOF® and microfluidics technologies, we develop, manufacture, and market multi-omic solutions to drive meaningful insights in health and disease, identify biomarkers to inform decisions, and accelerate the development of more effective therapies. Our customers are leading academic, government, pharmaceutical, biotechnology, and plant and animal research laboratories worldwide. Together with them, we strive to increase the quality of life for all. For more information, visit fluidigm.com.
Fluidigm, the Fluidigm logo, Biomark, and CyTOF are trademarks and/or registered trademarks of Fluidigm Corporation in the United States and/or other countries. Fluidigm products are provided for Research Use Only. Not for use in diagnostic procedures.
Original post https://alertarticles.info
