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The firm's assay is also CE marked for use with nasal swabs, nasopharyngeal swabs, nasal wash and aspirates, and bronchoalveolar lavages.
The test is for use with the company's Liaison MDx instrument and can be used alone or with the Simplexa COVID-19 Direct kit.
The combination flu and RSV assay can be used alone or in combination with the company's Simplexa COVID-19 Direct assay for SARS-CoV-2 infection.
The disease occurs when cytomegalovirus infection is passed from a mother to an unborn child and can lead to severe and potentially fatal outcomes.
An analysis by Cleveland Clinic researchers finds some SARS-CoV-2 tests have a high false negative rate, NPR reports.
Seegene said Monday that the Health Canada approval will enable hospitals and licensed labs there to run the assay immediately for high-volume testing.
DiaSorin becomes the seventh company to obtain EUA for a coronavirus test. Its assay runs on the sample-to-answer Liason MDX real-time PCR system.
The funds will support development of an assay on the DiaSorin Liason MDX sample-to-answer instrument.
The deal gives DiaSorin the exclusive rights to TTP's sample-to-answer diagnostic system for human in vitro diagnostic applications.
The firm said that with this clearance it now provides a comprehensive menu of VZV and HSV tests from swab and cerebrospinal fluid specimens.
The US Food and Drug Administration is to announce stricter standards for emergency authorizations of SARS-CoV-2 vaccines, reports the Washington Post.
The Associated Press reports Johnson & Johnson is starting a late-stage clinical trial of its candidate SARS-CoV-2 vaccine.
Bloomberg reports the budget of Operation Warp Speed is actually $18 billion, higher than the number typically cited.
In Genome Research this week: genomic analysis reveals role of super-spreaders in SARS-CoV-2, epigenetic drivers of cancer, and more.