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New Tests Enter the Scene as COVID-19 Rages On
Thermo Fisher Scientific is the latest company to be granted Emergency Use Authorization for a diagnostic to detect the coronavirus (COVID-19). Mayo Clinic also announced it has a test that been fully validated and submitted to FDA for review and EUA. The testing developments come after the Trump Administration announced over the weekend that there would be new strategies to limit the spread of the virus.
March 16, 2020
2 Min Read
Image by olgalionart on Pixabay.
Tests for the coronavirus (COVID-19) continue to roll in as the U.S. faces a public health crisis. Thermo Fisher Scientific and Mayo Clinic are the latest with diagnostic contributions.
Waltham, MA-based Thermo Fisher is the second company to be granted an Emergency Use Authorization for a commercially developed COVID-19 test. MD+DI reported Roche received this designation late last week too for the cobas SARA-COV-2 test.
In a press release, Thermo Fisher said the authorized test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. The company said the estimated time-to-result also includes time for sample preparation and instrument analysis.
"The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection,” Marc Casper, chairman, president and CEO of Thermo Fisher said in prepared remarks.
The news comes on the heels of two significant developments from Thermo Fisher, which include the company making a bid to acquire Qiagen and entering into a companion diagnostic collaboration for non-small cell lung cancer with Janssen.
Mayo Clinic’s said its test “Severe Acute Respiratory Syndrome (Coronavirus-2 (SARS CoV-2), Molecular Detection has been fully validated and submitted to FDA for review and EUA. Results from the test can come within 24 hours, Mayo Clinic said.
Vice President Mike Pence speaks during a press conference detailing the next steps in combatting the spread of COVID-19.
Latest COVID-19 Developments
Currently, the U.S is engaging in social distancing to stop the rapidly spreading disease. There are about 3,837 people in the U.S. that have been infected by COVID-19 and 70 have died from the disease, according to Worldometer. About 73 people have recovered.
During a Sunday news conference, the Trump Administration announced additional measures to help stem the tide of disease and said there would be drive-through testing for COVID-19. The first people allowed to use this testing will be healthcare workers and first responders and people over 65 who have symptoms consistent with the virus, according to a report from The Washington Post.
The associated press is reporting the first patient in a trial the National Institutes of Health is funding, will receive a dose of an experimental vaccine to protect against COVID-19. The trial is taking place at the Kaiser Permanente Washington Health Research Institute in Seattle, according to the AP report. The vaccine is being co-developed by NIH and Cambridge, MA-based Moderna
However, the AP reported Dr. Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases even if the safety tests go well it would take about a year to a year and a half for the vaccine to be used for widespread use.
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