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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.
News items for the in vitro diagnostic industry for the week of Oct. 19, 2020.
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.
Healthcare providers need multiplexed tests that can differentiate the flu from the coronavirus so they can treat patients quickly and appropriately.
The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.
The firm launched a CE-IVD marked test for extremely drug-resistant TB and expects to incorporate the multiplexing technology in other assays.
News items for the in vitro diagnostics industry for the week of June 29, 2020.
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.
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.
The WHO said that before point-of-care immunodiagnostic tests can be recommended, they must be validated in the appropriate populations and settings.