FDA Approves Miami Cancer Institute, a part of Baptist Health South Florida, to Perform New, In-house Test for COVID-19 in its Molecular Diagnostic Lab

The organization is the First in Florida, and one of 12 sites in U.S. to receive this emergency authorization to perform newly developed testing

This week, the Food & Drug Administration granted Emergency Use Authorization (EUA) for Baptist Hospital of Miami Molecular Diagnostic Laboratory at Miami Cancer Institute, to perform a new COVID-19 swab tests in-house. The test was developed at Miami Cancer Institute, which is part of Baptist Health.

Identification of COVID-19 patients is critical in order to either self-isolate at home or admit the patient to a specific area of the hospital. This in-house testing allows Miami Cancer Institute to perform a number of tests twice a day and receive results within 24 hours. The lab is able to perform 40 – 80 tests per day with capacity for more in the near future.

“Having this test allows us to expand our in-house testing capability, allowing us to make treatment decisions more quickly and quarantine patients appropriately,” said Edwin Gould, M.D., chief of pathology, Miami Cancer Institute. “We were fortunate to have all the highly sophisticated equipment and expertise needed already in-house– making the switch possible in a short timeframe.”

As an added layer of safety, the testing process begins in a leased GermFree trailer, which resides behind the Miami Cancer Institute facility and contains ventilated air space and laminar flow hoods. The remainder of testing is performed in the building’s laboratory. The GermFree trailer, which was used as a pharmacy during Miami Cancer Institute’s construction, includes equipment like microbiology hoods that allow for molecular testing of COVID-19.

Miami Cancer Institute is one of 12 hospital laboratories across the country to receive this authorization. Others include Stanford Health Care, Northwestern Medicine, Yale New Haven Medicine and Children’s Hospital of Philadelphia.


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