As the novel strain of coronavirus, COVID-19, spreads rapidly throughout the United States, it is important to test individuals who are either showing symptoms of COVID-19 or who have been directly exposed to an individual who has tested positive for COVID-19. “Rapid diagnosis is critical to managing people infected with COVID-19,” (Hologic, 2020) and currently people are not being tested rapidly. Through increased testing, the spread of the virus can slow and therefore, the pressure that this pandemic is putting on hospitals and hospital supply chains could be relieved.
Although it is very important, “the U.S. is way behind when it comes to testing people for the coronavirus” (Khazan, 2020). This lack of testing can all be improved upon with Hologic’s release of the SARS-CoV-2, a test for COVID-19. Along with Hologic’s new test, the FDA is now allowing commercial coronavirus testing in which companies will not have to submit their tests for federal review.
The FDA granted “Emergency Use Authorization” (Hologic, 2020) for Hologic’s test for the virus causing COVID-19. The approval came shortly after COVID-19 was declared a pandemic by the World Health Organization (Hologic, 2020). Hologic anticipates manufacturing approximately 600,000 tests a month and shipping them across the United States. The quantity of tests that will soon be available will ensure that more people will be tested and therefore the spread of the virus should slow.
Due to the dire need, created by the lack of testing, the FDA decided that they are allowing commercial coronavirus testing. Many companies have already signed up to test individuals and the FDA is “trusting companies and labs to make sure their tests in the field are well-validated” (Hale, 2020). The combination of Hologic’s new test along with the FDA announcement should decrease the rate of COVID-19 spread.
Through these new methods of testing, the strains on hospitals and hospital supply chains theoretically will decrease. More tests will help eliminate the spread of the virus and therefore hospitals will have relief.
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Coronavirus Update: Hologic Molecular Test Receives FDA Emergency Use Authorization. Retrieved from https://www.hologic.com/coronavirus-test?9781907a=e9c733a5
Hale, C. (2020). FDA opens the gates to commercial coronavirus testing without agency review. Retrieved from https://www.fiercebiotech.com/medtech/fda-opens-gates-to-commercial-coronavirus-testing-without-agency-review?mkt_tok=eyJpIjoiWVdRM01UUTBNbVprTjJGaiIsInQiOiI3dDFmOFNKaW5pZmJScjE0d3N0dEw5bElMSUxhQWVQUFhsMk5NdVFcL3VXUEZBVXV4RFB2a3ZVZjVpeUx5UWp1aXVZejNiQ3pHUzZTTHlSRXFQRnNYSE9JMUhFY29ZVW1UTFpDd0hPWVFDSGk4Wk9cLzJCXC9ESEtIb1VlekNIMlFlNCJ9&mrkid=791689
Khazan, O. (2020). The 4 Key Reasons the U.S. Is So Behind on Coronavirus Testing. Retrieved from https://www.theatlantic.com/health/archive/2020/03/why-coronavirus-testing-us-so-delayed/607954/