Emergency Use Authorization: Page 2

BD, CerTest launch monkeypox assay for global and U.S. markets

The companies used the BD Max System open-architecture reagent suite to develop the CerTest Viasure Monkeypox molecular assay. The assay comes in a lyophilized format and in the form of a tube that snaps into the test-specific position on the BD Max ExK TNA extraction strip supplied by BD, the companies said.

September 25, 2022

OIG: FDA recommendations for future pandemics

OIG offered numerous recommendations to manage such infectious disease emergencies, saying the FDA should access and, when appropriate, revise its guidance for Emergency Use Authorization (EUA) submissions for tests.

September 21, 2022

FDA issues monkeypox testing guidance, first EUA to Quest

The agency issued guidance that outlines its views regarding enforcement policies, recommendations for emergency use authorization (EUA) requests for monkeypox diagnostic tests, and plans to prioritize review of EUA requests.

September 6, 2022

Nanomix, Mobility to develop COVID-19 antibody POC test

Under the agreement, Nanomix would supply the product elements and Mobility Health would complete development and validation of the test.

September 1, 2022

Mylab and Hemex launch new COVID-19 test

The lateral flow test is the result of a collaborative effort to develop COVID-19 point-of-care testing in India.

July 6, 2022

BD nabs CE Mark for respiratory viral panel

The panel, a molecular diagnostic combination test for SARS-CoV-2, influenza A + B, and respiratory syncytial virus (RSV), uses a nasal swab or nasopharyngeal swab sample.

June 30, 2022

Cue Health seeks full FDA nod for molecular COVID-19 test

The test, which received emergency use authorization from the FDA in June 2020, has been used by millions of Americans and by healthcare institutions such as Johns Hopkins Medicine, Mayo Clinic, Memorial Hermann, and UPMC Children's Hospital of Pittsburgh, according to Cue.

May 3, 2022

Truvian appoints four top executives

Truvian has appointed Ajay Bansal as chief financial officer, Tyler Jensen as chief product officer, Joe Benson as vice president of strategy and portfolio management, and Eric Zieger as vice president of global sales.

April 20, 2022

KSL launches COVID-19 immunity test

KSL's COVID-19 immune index can help monitor effectiveness of COVID-19 virus protection through a simple blood test. The test allows patients to understand their immune status so they can better time booster vaccines.

April 5, 2022

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

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

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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