Developments in diagnostics for COVID-19
S. Himmelstein | March 18, 2020Companies worldwide are focused on developing and distributing diagnostic tests for COVID-19 to laboratories, and marketing products and services engineered to help patients and healthcare providers cope with the pandemic.
Here is a sampling of recent advances in diagnostic testing technology.
Waltham, Massachusetts-based Thermo Fisher Scientific has received an emergency use authorization, or
A 3D print of a spike protein of SARS-CoV-2 in front of a 3D print of a SARS-CoV-2 virus particle. The spike protein (foreground) enables the virus to enter and infect human cells. On the virus model, the virus surface (blue) is covered with spike proteins (red) that enable the virus to enter and infect human cells. Source: National Institutes of HealthEUA, from the U.S. Food and Drug Administration (FDA) for its diagnostic test to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19. Approved for use in Clinical Laboratory Improvement Amendments-certified facilities, the assay returns results within four hours.
A high-throughput testing platform from Hologic was also granted EUA from the agency for use in hospitals and laboratories. The Panther Fusion SARS-CoV-2 test provides results in less than three hours and processes up to 1,150 coronavirus tests in a 24-hour period. The company expects to produce nearly 600,000 test kits each month and is making additional investments to further increase production capacity.
An assay with a 24-hour turnaround time has also been developed at the Mayo Clinic. The fully validated SARS CoV-2 molecular detection test will be used to provide data to the FDA for review and EUA. The real-time polymerase chain reaction (PCR) test is designed to identify SARS-CoV-2 from a variety of clinical samples and has been validated to test respiratory samples collected from suspected COVID-19 patients.
Swiss drug and diagnostics maker Roche received an EUA from the FDA for its Cobas SARS-CoV-2 test designed to use nasopharyngeal and oropharyngeal swab samples to detect the coronavirus, Used in conjunction with the company’s Cobas 6800 and 8800 lab-testing systems, the diagnostic is designed to provide thousands of results over a 24-hour period.
There is some progress on the vaccine front: A Phase 1 clinical trial for an investigational COVID-19 vaccine is underway at Kaiser Permanente Washington Health Research Institute in Seattle. The open-label trial plans to enroll 45 healthy adults aged 18 to 55 years over a six week period, and the first study participant has been administered a dose of the mRNA-1273 vaccine developed by National Institute of Allergy and Infectious Diseases scientists and collaborators at Moderna Inc. in Cambridge, Massachusetts.
Use this map maintained by Johns Hopkins University to keep track of the global COVID-19 case count.
And wash your hands.