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The Warsaw, Poland-based startup expects to submit a rapid SARS-CoV-2 molecular test for EUA and is seeking US manufacturing and distribution partners.
The firm launched a CE-IVD marked test for extremely drug-resistant TB and expects to incorporate the multiplexing technology in other assays.
While new ways to carry out pool testing for SARS-CoV-2 abound, questions remain about sensitivity issues and the regulation of such tests.
The firm expects to launch a 510(k)-cleared version of its Bladder EpiCheck recurrence assay early next year followed by an RUO early-stage lung cancer assay.
The panel can detect and differentiate SARS-CoV-2 and 20 other pathogens known to cause serious respiratory disease from nasopharyngeal swabs in symptomatic patients.
The QiaStat-Dx Respiratory SARS-CoV-2 Panel can detect and differentiate SARS-CoV-2 and 21 other respiratory pathogens in symptomatic patients.
The single-tube real-time PCR-based test has also received CE marking, according to Seegene, and is now commercially available.
Qiagen obtained CE marking for its Therascreen PIK3CA RGQ PCR kit to aid in identifying breast cancer patients with a PIK3CA mutation.
The firm will use the new funds to accelerate development of products, expand partnerships, and support commercialization of its two multiplex panels.
The firm's tick-borne pathogens panel was also recently the subject of a clinical study, showing high accuracy in detecting numerous infectious agents.
Two COVID-19 vaccine developers have released their trial protocols to build public trust, the New York Times reports.
A new analysis finds the rapid COVID-19 test from DnaNudge to be highly accurate, Reuters reports.
In Science this week: global citizens' assembly on genome-editing technologies proposed, epigenetic markers predict metformin response, and more.
According to the Verge, many US states are not including positive results from rapid COVID-19 testing in their case numbers.