Emergency Use Authorization: Page 3

Anavasi grows executive team after funding rounds
New appointments include Scott Hales as chief financial officer, Guy Ellis as chief operating officer, and James McMenamy as chief commercial officer. The company is also preparing for an announcement in the first quarter of 2022 on a series A funding round.
January 13, 2022
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LumiraDx ships COVID, flu tests to Europe, ups revenues
The company's revenues for the fourth quarter of 2021 are expected to be $119 million, in comparison to revenues of $101 million during that same period of 2020, according to preliminary results. These tests are expected to account for about $77 million of revenue in the fourth quarter of 2021, which has been driven by higher testing rates associated with the omicron variant of SARS-CoV-2.
January 11, 2022
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NY OKs Applied DNA's COVID-19 assay
With the conditional approval, Applied DNA Clinical Labs, a clinical laboratory subsidiary of Applied DNA Sciences, can immediately employ the Linea 2.0 assay to support New York-based safeCircle clients for the diagnostic testing of COVID-19. The assay is conditionally approved for individual and pooled testing.
January 4, 2022
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eMed releases 1M COVID home tests for holiday season demand
The kits can be purchased through eMed.com, the company said, and provide results in 15 minutes. The kits are authorized under an emergency use authorization from the U.S. Food and Drug Administration, eMed said.
December 19, 2021
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FDA clears GenBody's COVID-19 test for asymptomatic people
Specifically, GenBody's COVID-19 antigen test kits can now be used for individuals without symptoms or other epidemiological reasons to suspect COVID-19 "when tested twice over two or three days, with at least 24 hours and no more than 48 hours between tests," the company stated in a release.
December 8, 2021
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Sense raises $65M in series B financing
The Veros COVID-19 test is an instrument-free, single-use, rapid, point-of-care molecular diagnostic testing platform that produces results within 15 minutes.
November 16, 2021
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Ellume issues recall of test for SARS-CoV-2 infection
The move comes in response to a safety communication the FDA released October 5. The recall is categorized as class I, the most serious type, the FDA said. Total affected tests are approximately 2 million.
November 9, 2021
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Anavasi secures $14.9M from NIH for SARS-CoV-2 assay
AscencioDx is in clinical trials, and Anavasi expects to file an emergency use authorization (EUA) with the U.S. Food and Drug Administration soon, it said. The EUA will establish the effectiveness of the test in point-of-care settings such as physician offices, emergency rooms, urgent care clinics, mobile testing sites, and colleges and universities, according to Anavasi.
November 9, 2021
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FDA authorizes 11th over-the-counter COVID-19 test
The FDA issued an emergency use authorization for the Detect COVID-19 Test, an OTC COVID-19 diagnostic molecular test. The test requires the use of a compatible smartphone and a downloadable app to provide testing instructions and delivers results in about one hour, the FDA said.
October 28, 2021
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Hologic launches multiplex COVID/flu assay
The three viruses can present with overlapping clinical symptoms, Hologic said. The new assay runs on Hologic's fully automated Panther system, which can provide initial results in approximately three hours and can process more than 1,000 tests in 24 hours, the company said.
October 27, 2021
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NanoDx, SkyWater develop nanoscale tech for COVID testing
The nanosensor features wires that find and quantify biomarkers and infections in the blood; the technology is based on research that came out of Harvard University, according to NanoDx.
October 5, 2021
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FDA issues alert on Ellume at-home COVID-19 tests
The FDA said the incorrect results only occurred in certain lots of the Ellume COVID-19 Home Test, and that negative test results did not appear to be affected by the issue. The agency said it was working with Ellume on corrective steps to address the reason for the manufacturing issue and to resolve the problem.
October 4, 2021
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