EUA to Approved Pipeline for COVID-19 Tests

Oct  6, 2021 /DiagnosticsWorld/ -- The U.S. Food and Drug Administration (FDA) has fast-tracked tests under Emergency Use Authorization (EUA) during the coronavirus pandemic. Along the way, there has been a flurry of activity in a short time. 

But what will happen to the many COVID-19 tests that have been issued EUAs once the public health emergency winds down? Diagnostics World gathered insight from the FDA and several companies to learn more about the road ahead.find timely tests.

WASHINGTON DC, Sep  28, 2021 /USA  TODAY/ -- The Biden administration will spend nearly $2 billion on coronavirus home tests in tandem with a vaccinate-or-test mandate for corporate America.

But experts say the administration's purchase of 280 million non-laboratory tests won't be enough to meet testing needs as private employers, K-12 schools and a delta-variant-driven testing surge make it harder to find timely tests.

NEW YORK, Aug 31, 2021 /Clinical Lab Products Magazine/ -- Rover Labs, a diagnostics technology leader in end-to-end COVID testing, announced today the launch of Rover CloudLIS, a proprietary, HIPAA-compliant, cloud-based laboratory information system (LIS). Rover CloudLIS offers diagnostic laboratories and COVID-19 test manufacturers around the world a better way to track and report test results instantly at scale.

NEW YORK, Aug 31, 2021 /PRNewswire/ -- Rover Labs, a diagnostics technology leader in end-to-end COVID testing, announced today the launch of Rover CloudLIS, a proprietary, HIPAA-compliant, cloud-based laboratory information system (LIS). Rover CloudLIS offers diagnostic laboratories and COVID-19 test manufacturers around the world a better way to track and report test results instantly at scale.

STATEN ISLAND, N. Y., Jul 06, 2021 /SILive.com/ -- Ten Staten Island schools are using saliva-based coronavirus (COVID-19) testing during a two-month pilot program that started in June.

Throughout the 2020-2021 school year, which recently ended, students and staff in reopened school buildings were subject to random coronavirus testing to ensure safe in-person learning. Now, about 50 schools citywide are using saliva testing during a pilot program with Rover Labs, using technology developed by Fluidigm Corporation.

QUEENS, N. Y., Jun 24, 2021 /Queens Chronicle/ -- The city’s Department of Education has teamed up with Rover Labs, a diagnostics technology company in Manhattan with a lab in New Jersey, to provide saliva testing for 50 city schools during a two-month pilot program, which started in June.

New York City public schools have instituted mandatory random weekly testing in all reopened school buildings to ensure safer in-person learning. Through a new pilot program, Rover Labs is testing students and staff in New York City public schools from all five boroughs with a saliva-based test that is turnkey, cost-effective, highly sensitive and seamless to implement.

NEW YORK, Jun 17, 2021 /PRNewswire/ -- Rover Labs, a diagnostics technology leader in end-to-end saliva testing, is providing saliva-based COVID-19 testing to approximately 50 New York City public schools during a two-month pilot program that began on June 1 using technology developed by Fluidigm Corporation (Nasdaq:FLDM).

New York, NY, Oct 1, 2020 /Columbia Engineering/ -- A promising new COVID-19 rapid-testing technology platform developed by Rover Diagnostics and Columbia Engineering has been selected by the National Institutes of Health (NIH) to enter Phase 1 of the Rapid Acceleration of Diagnostics (RADx) initiative to support new COVID-19 testing technologies. The affordable, portable, and ultrafast point-of-care Rover platform provides reverse transcription polymerase chain reaction (RT-PCR) results in eight minutes, faster than any other test of its kind, with targeted accuracy to match laboratory-based tests.

Apr 10, 2020 /Molecular Ideas/ -- Welcome to our first Startup Showcase on Molecular Ideas! Today, we explore how Rover Diagnostics is arming patients, practitioners, and public health officials with critical information by innovating on one of molecular science’s most fundamental tools – PCR.