WHO

Nov 19, 2020

OraSure Developing Rapid SARS-CoV-2 Antigen Test for Eventual OTC, At-Home Use

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The company is drawing on its previous experience developing and commercializing its HIV self-test to make progress on a test that could be used for three different indications.

Oct 22, 2020

In Brief This Week: Oxford Immunotec, Eurofins, WHO, and More

News items for the in vitro diagnostic industry for the week of Oct. 19, 2020.

Sep 29, 2020

WHO Leads Partnership to Roll Out 120M Rapid COVID-19 Tests for Low- and Middle-Income Countries

Over six months, Abbott and SD Biosensor will provide rapid antigen tests to a variety of countries at a maximum price of $5 per test.

Sep 08, 2020

As Flu Season Nears, Dx Companies Shift Attention to Multiplex Tests for SARS-CoV-2, Influenza

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Healthcare providers need multiplexed tests that can differentiate the flu from the coronavirus so they can treat patients quickly and appropriately.

Sep 08, 2020

Roche BK Virus Test Garners FDA Clearance

The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.

Jul 17, 2020

Cepheid Debuts 10-Color Molecular Detection Technology With New Tuberculosis Test

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The firm launched a CE-IVD marked test for extremely drug-resistant TB and expects to incorporate the multiplexing technology in other assays.

Jul 01, 2020

In Brief This Week: Centogene, Humana, Enzo Biochem, Todos Medical, and More

News items for the in vitro diagnostics industry for the week of June 29, 2020.

Jun 30, 2020

WHO Seeks $6B Diagnostics Support for Unrelenting COVID-19 Pandemic

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Through its Access to COVID-19 Tools-Accelerator program, or ACT-A, WHO hopes to quickly identify and scale up high performing rapid antigen-based diagnostics.

May 05, 2020

Genedrive Hepatitis C Test Garners WHO Prequalification, Firm Plans £8M Raise

The test will be included in the World Health Organizations list of prequalified in vitro diagnostics and UN agencies will be able to procure it.

Apr 09, 2020

WHO Discourages Use of POC Coronavirus Immunoassays for Clinical Decision-Making

The WHO said that before point-of-care immunodiagnostic tests can be recommended, they must be validated in the appropriate populations and settings.

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WHO

OraSure Developing Rapid SARS-CoV-2 Antigen Test for Eventual OTC, At-Home Use

In Brief This Week: Oxford Immunotec, Eurofins, WHO, and More

WHO Leads Partnership to Roll Out 120M Rapid COVID-19 Tests for Low- and Middle-Income Countries

As Flu Season Nears, Dx Companies Shift Attention to Multiplex Tests for SARS-CoV-2, Influenza

Roche BK Virus Test Garners FDA Clearance

Cepheid Debuts 10-Color Molecular Detection Technology With New Tuberculosis Test

In Brief This Week: Centogene, Humana, Enzo Biochem, Todos Medical, and More

WHO Seeks $6B Diagnostics Support for Unrelenting COVID-19 Pandemic

Genedrive Hepatitis C Test Garners WHO Prequalification, Firm Plans £8M Raise

WHO Discourages Use of POC Coronavirus Immunoassays for Clinical Decision-Making

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Breaking News

Somalogic Closes $121M Series A Funding

FDA Issues EUAs for Gravity Diagnostics Coronavirus Test, Sample Self-Collection Kit from RapidRona

Kantaro Biosciences Gets FDA Emergency Use Authorization for Coronavirus Antibody Test

In Brief This Week: Quest Diagnostics, Fluidigm, BD, and More

Tempus Gets CE Mark for xT Tumor Sequencing Assay

BTIG Downgrades Fulgent Genetics from Buy to Neutral

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OraSure Developing Rapid SARS-CoV-2 Antigen Test for Eventual OTC, At-Home Use