Massachusetts General Hospital, the Infectious Disease Diagnostics Laboratory at Children's Hospital of Philadelphia, and the Diagnostic Molecular Laboratory at Northwestern Medicine, have received federal approval to produce tests to detect COVID-19.
All three organization's real-time tests were cleared by the U.S. Food and Drug Administration last week for detecting COVID-19 using nasopharyngeal swabs, nasal swabs, and bronchoalveolar lavage specimens.
The FDA granted approval for the three tests under guidance released by the agency on March 31 for molecular-based, laboratory-developed tests for detecting the coronavirus.
The slow roll-out of testing for the coronavirus has prompted a more hospitals to develop their own diagnostic capabilities, which they say offers them the best chance to mitigate the impact of the outbreak.
It also has given them better control over who to test and expedites the results.
Along with those advantages are added regulatory burdens, however.
Last week, the Trump administration sent a letter to hospitals requesting that they report their COVID-19 testing data to HHS on a daily basis.
"Academic, university and hospital 'in-house' labs are performing thousands of COVID-19 tests each day, but unlike private laboratories, the full results are not shared with government agencies working to track and analyze the virus," Vice President Mike Pence wrote.
Test results are due to HHS every day at 5 p.m. ET.
