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Tag: COVID-19 Test


Biomarker, Innovation

FDA grants EUA for Lucira Health’s COVID-19 & Flu Test

November 23, 2022

Via: Medical Device Network

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Lucira Health’s COVID-19 & Flu Test for use in point-of-care settings. The nucleic acid amplification test (NAAT)/molecular test has been developed for the simultaneous rapid in […]


Regulatory

How UnitedHealth responded to the new federal requirement for home COVID-19 test coverage

January 19, 2022

Via: FierceHealthcare

Following a federal directive to cover over-the-counter COVID-19 tests, UnitedHealth Group executives said Wednesday the company was able to quickly pivot in a matter of days to ensure members could access reimbursement for the tests. Chief Operating Officer Dirk McMahon […]


News

Coronavirus company news summary – Sanger Sequencing detects SAR-CoV-2 variants – Australian regulator to assess rise in Covid-19 test costs

January 4, 2022

Via: medicaldevice-network.com

Milford Molecular Diagnostics Laboratory’s Sanger Sequencing is claimed to detect all known SARS-CoV-2 variants of concern and interest, including Omicron and Delta. Director Sin Hang Lee said that the high complexity CLIA-certified laboratory offers the diagnostic test to patients as […]


News

Coronavirus company news summary – World Wide Labz and Baebies to provide Covid-19 RT-PCR testing – US CDC mulls negative Covid-19 test for asymptomatic individuals

January 3, 2022

Via: medicaldevice-network.com

A CLIA certified laboratory in the US, World Wide Clinical Labz, and Baebies have collaborated to provide ultra-rapid real-time reverse transcription-polymerase chain reaction (RT-PCR) testing for Covid-19. As against traditional RT-PCR test results that are reported after a minimum of […]


News

Coronavirus company news summary – Merck to build flow membrane production facility – FDA grants EUA for Siemens Healthineers’ Covid-19 test

December 30, 2021

Via: medicaldevice-network.com

Merck’s Life Science business sector has secured a contract award worth €121m from the US Department of Defense (DoD) to construct a lateral flow membrane production facility at the company’s site in Sheboygan, Wisconsin. The new facility will produce the […]


News

Sorrento Therapeutics’ COVISTIX Covid-19 test detects Omicron variant

December 28, 2021

Via: medicaldevice-network.com

Sorrento Therapeutics has announced that the initial testing of its COVISTIX Covid-19 virus rapid antigen detection test showed its ability to detect Omicron besides the original SARS-CoV-2 virus and other major variants of concern. The COVISTIX detection levels were found […]


News

Coronavirus company news summary – Thermo Fisher updates Covid-19 mutation panel – US to offer Covid-19 test kits to fight Omicron

December 22, 2021

Via: medicaldevice-network.com

Thermo Fisher Scientific has revised its Applied Biosystems TaqMan SARS-CoV-2 Mutation Panel to facilitate direct identification of the Omicron variant of the virus. Made with an adaptable menu of real-polymerase chain reaction (PCR) genotyping assays, the panel can precisely detect […]


Biomarker, Innovation, Research

Researchers develop new COVID-19 RNA test that produces fast and accurate results

January 5, 2021

Via: The Medical News

The researchers believe their method could deliver a test that is not only fast but also sufficiently sensitive. The test does not require samples to be treated at high temperatures, and it can be performed using standard laboratory equipment, making […]


Innovation, Regulatory, Research

US FDA grants emergency use authorisation for Roche’s Covid-19 test

May 4, 2020

Via: medicaldevice-network.com

Roche has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for an Elecsys Anti-SARS-CoV-2 antibody test for the coronavirus (Covid-19). The test is expected to help identify patients who have been exposed to Covid-19 and […]


Innovation, Research

Hologic to launch new molecular assay for Covid-19 detection

April 30, 2020

Via: medicaldevice-network.com

Hologic is set to launch a new Aptima molecular assay that will run on the Panther system for the detection of SARS-CoV-2 virus, which causes Covid-19. The Panther system is a fully automated, high-throughput molecular diagnostic platform installed in 60 […]


Innovation, Research

Siemens Healthineers develops Covid-19 antibody test

April 24, 2020

Via: medicaldevice-network.com

The test will help to identify the antibodies of SARS-CoV-2, the virus strain that causes the disease, in the individuals who have developed an immune response to the virus. Currently, Siemens Healthineers is working to receive emergency use authorisation (EUA) […]


Regulatory

Abbott receives FDA emergency use authorisation for new Covid-19 test

March 30, 2020

Via: medicaldevice-network.com

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Abbott’s new molecular point-of-care test to detect coronavirus (Covid-19). The latest test runs on the company’s ID NOW platform and delivers positive results in five minutes […]


Regulatory

FDA grants emergency use authorisation for Abbott’s Covid-19 test

March 19, 2020

Via: medicaldevice-network.com

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Abbott’s molecular test for coronavirus (Covid-19). The molecular tests are run on the company’s m2000 RealTime System, a molecular solution with a broad range of tests. […]


Innovation, Research

US health network develops rapid response Covid-19 test

March 13, 2020

Via: medicaldevice-network.com

New Jersey-based health network Hackensack Meridian Health’s Center for Discovery and Innovation (CDI) has created a rapid response test for diagnosing Covid-19. The developers hope this will allow for a more effective triage system in hospitals and better control the […]


Regulatory

New York City confirms two new cases of coronavirus contracted through community spread

March 5, 2020

Via: CNBC

New York City Mayor Bill de Blasio confirmed Thursday two new cases of COVID-19 — a man and a woman with no known connection to other people recently diagnosed with the virus. “To ensure we are able to test as […]


Innovation, Research

Promega’s custom manufacturing capabilities support rapid development of Logix Smart COVID-19 Test

February 26, 2020

Via: The Medical News

Promega Corporation is being recognized by Utah-based Co-Diagnostics, Inc. for the support Promega custom manufacturing provided in the rapid development and launch of the new Logix Smart™ COVID-19 Test. Co-Diagnostics yesterday afternoon announced its coronavirus test received CE mark approval […]