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

Expediting Treatment of COVID-19 Patients and Enhancing Testing Resources for Caregivers in Oklahoma

Workflow from Extraction through Real-Time PCR Using Fluidigm Microfluidics Technology and Reagents

SOUTH SAN FRANCISCO, Calif., April 23, 2020 (GLOBE NEWSWIRE) -- Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that OU Medicine, the University of Oklahoma and the Oklahoma Medical Research Foundation (OMRF) intend to utilize Fluidigm^® microfluidics technology and certain reagents to test individuals for the SARS‑CoV‑2 virus, which causes COVID-19. The spread of this disease has been declared a global pandemic by the World Health Organization.

The test, developed by OMRF and OU Health Sciences Center scientists and utilizing Fluidigm products, is intended for large-scale testing of patients across the OU Medicine health care system. OU Medicine has applied for Emergency Use Authorization (EUA) for the test from the U.S. Food and Drug Administration (FDA).

“Solutions that offer scale and high-speed processing are critically important in ramping up testing capabilities for COVID-19,” said OMRF President Stephen Prescott, MD. “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.”

High-complexity labs certified under the Clinical Laboratory Improvement Amendments in the United States are eligible under new FDA guidance to create their own diagnostic test kits for COVID-19. OU Medicine, the University of Oklahoma and OMRF are among academic and government organizations utilizing Fluidigm microfluidics technology and reagents in COVID‑19 testing. The institutions validated a workflow designed to be run on the Fluidigm Biomark™ HD system.



“We are grateful for the collaboration and leadership of the researchers at OU Health Sciences Center and OMRF. This partnership with three Oklahoma health care 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 health care providers to be routinely tested to ensure their safety and that of everyone they encounter. Increased testing will also allow more patients without COVID-19 to access specialty care at OU Medicine, including surgeries, procedures and other diagnostic testing,” Spicer said.



“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.”

Microfluidics technology generates more data and uses a fraction of expensive testing reagents per sample as compared with more traditional, microwell plate-based PCR technology. Fluidigm Biomark HD and the company’s microfluidics technology, in particular, enable automated high-throughput assembly of PCRs at the nanoscale level.

“Since the beginning of the COVID-19 outbreak, adequate resources for testing have been a serious challenge for health care systems around the world,” said Chris Linthwaite, President and CEO of Fluidigm. “Speed, scale and automation are critical components for delivering timely results. The Biomark HD platform can generate more than 6,000 individual test results per day with just one hour of hands-on time. A single system supports more than 2 million annual tests, and we are partnering with labs around the world to build out critically needed testing infrastructure.”

“We are excited to support OU Medicine, the Oklahoma Medical Research Foundation and the University of Oklahoma Health Sciences Center in this incredibly important program. 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 development of vaccines and therapeutic candidates. The COVID-19 testing program for Oklahoma City positions that community at the forefront of pandemic preparation efforts in the global fight against this virus.”

In a separate program, the Icahn School of Medicine at Mount Sinai and a group of other U.S. medical schools are developing a new epigenetic test for early COVID-19 detection designed for the Biomark HD, with the intent to seek EUA from the FDA.

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, the Fluidigm logo, Biomark, and CyTOF are trademarks and/or registered trademarks of Fluidigm Corporation in the United States and/or other countries. All other trademarks are the sole property of their respective owners. Fluidigm products are provided for Research Use Only. Not for use in diagnostic procedures.

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 .

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 . 

About Oklahoma Medical Research Foundation

OMRF () 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.

Forward-Looking Statements for Fluidigm

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding the implementation of Fluidigm microfluidics technology and products by third parties and the anticipated benefits of, and applications and demand for, such products. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results, including but not limited to risks relating to the potential adverse effects of the coronavirus pandemic on our business and operating results during 2020; our ability and/or the ability of the research institutions utilizing our products and technology to obtain EUA FDA and any other requisite approvals to use our products and technology for diagnostic testing purposes; challenges inherent in developing, manufacturing, launching, marketing, and selling new products; risks relating to company research and development and distribution plans and capabilities; interruptions or delays in the supply of components or materials for, or manufacturing of, Fluidigm products; potential product performance and quality issues; intellectual property risks; and competition. Information on these and additional risks and uncertainties and other information affecting Fluidigm business and operating results is contained in Fluidigm’s Annual Report on Form 10-K for the year ended December 31, 2019, and in its other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Fluidigm disclaims any obligation to update these forward-looking statements except as may be required by law.

Media:

Mark Spearman

Senior Director, Corporate Communications

650 243 6621

Investors:

Agnes Lee

Vice President, Investor Relations

650 416 7423