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2020-03-19| COVID-19

Abbott’s Homemade Coronavirus Test bags FDA’s Emergency Authorization

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

Less than a week since approving Roche and Thermo Fisher Scientific’s tests, the USFDA has green-lighted homemade diagnostic kits developed by Abbott Laboratories, making it the ninth coronavirus test to be granted emergency authorization by the agency. The company announced that it will immediately deliver 150,000 kits to hospitals and academic medical centers and will ramp up the production to hit the target of 1 million tests per week.

Despite preventive measures, the COVID-19 cases are on the rise. As of today, there are more than 244,000 cases of COVID-19 globally with >13,000 cases in the U.S. alone. In the last months, the Trump government has been severely criticized for the lack of diagnostic tools to screen potential COVID-19 patients. According to the Centers for Disease Control and Prevention (CDC), only 30,000 tests have been performed so far in a country of 300 million people.

The U.S. government has now gone into full speed to tackle this crisis, as it emergency authorized Roche’s cobas SARS-CoV-2 diagnostic test last week, the third emergency authorization after CDC’s 2019-nCoV Real-time RT-PCR diagnostic panel. Within a week, five more companies got back-to-back emergency authorizations for their diagnostic tests which include Thermo Fisher Scientific, Hologic Inc., Laboratory Corporation of America, Quidel Corporation and Quest Diagnostics. Abbott is the ninth company to bag emergency authorization for its SARS-CoV2 test.

m2000 Real-Time system (Image Courtesy: Abbott Laboratories)

Abbott, a global leader in infectious disease testing is well known for the development of the very first HIV test. Abbott’s long-standing discovery program is committed to identifying new and unknown pathogens and develops tests to address new threats. Its COVID-19 test can be run on the company’s m2000 Real-Time system, a PCR based platform capable of running a broad menu of tests, including ones for infectious diseases by amplifying genes from pathogens. There are systems already up and running in more than 175 hospitals and academic medical centers, making it easy for health care workers to adapt the test for screening of patients.

“A global challenge like coronavirus requires the commitment and cooperation of everyone who has the ability to help address it,” said Miles D. White, chairman, and chief executive officer, Abbott. “I’m proud of the Abbott team and what they’ve accomplished in such a short period of time, and I want to thank the Administration and the FDA for their partnership in making this happen.”

The dire situation that existed in the past weeks seems to be improving as major commercial laboratories have started shipping kits and assays which can help to screen several people at a time and prevent the virus from spreading further.

Related Article: Hunt for mRNA-based Coronavirus Vaccine Intensifies after BioNTech’s Alliance with Fosun Pharma, Pfizer

References
  1. https://abbott.mediaroom.com/2020-03-18-Abbott-Receives-FDA-Emergency-Use-Authorization-and-Launches-Test-to-Detect-Novel-Coronavirus
  2. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov

 

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