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April 6, 2020

Leica receives FDA emergency use clearance to diagnose Covid-19

Leica Biosystems has received the US Food and Drug Administration (FDA) clearance for its Aperio ImageScope DX Viewer for remote diagnosis of coronavirus (Covid-19) under emergency use.


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Leica Biosystems has received the US Food and Drug Administration (FDA) clearance for its Aperio ImageScope DX Viewer for remote diagnosis of coronavirus (Covid-19) under emergency use.

The software enables pathologists to safely view images acquired through Aperio AT2 DX Scanner and diagnose cases from remote locations.

Leica Biosystems senior medical director Keith Wharton said: “In this time of critical need due to the Covid-19 pandemic, the Aperio AT2 DX system, including remote use of the Aperio ImageScope DX viewer, will allow pathologists to maintain a high standard of care, but now from remote locations using a digital pathology workflow.”

Commenting on the new development, Leica Biosystems president Melissa Aquino said: “This remote use capability will be transformative and help alleviate the pressure that the emergence of the Covid-19 outbreak has put on healthcare facilities.”

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Based in Germany, the company has branches in approximately 100 countries across the world. It specialises in workflow solutions and automation.

Meanwhile, the world is witnessing a rise in coronavirus cases. According to the latest reports, the number of confirmed cases has crossed one million with 69,498 deaths.

In the US, 337,637coronavirus cases have been reported, while the death toll has reached 9,647.

To meet the ongoing demand for Covid-19 testing, US FDA recently relaxed its regulations around Covid-19 diagnosis.

Currently, the tests developed and used by laboratories across the country can be authorised by state Departments of Health without direct engagement from the FDA.

In addition, the developers are not required to pursue an emergency use authorisation (EUA) with the FDA to have their assays approved.

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