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Quidel President and CEO Doug Bryant said this week that the company expects to complete clinical trials by the end of the current quarter to support a subsequent application for US regulatory approval of its AmpliVue C.
Quest Diagnostics said this week that the US Food and Drug Administration has granted 510(k) clearance for its Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler.
Roche last week said that it has received US Food and Drug Administration approval of a new pre-analytical instrument that integrates primary tube handling into its Cobas molecular testing platform.
Quidel said this week that it has received the CE mark for its AmpliVue C. difficile assay, making it the first commercially available test using Quidel's non-instrumented format.
By Ben Butkus
Quidel this week provided an update on its budding molecular diagnostics business, noting that it saw "significant progress" in each of its three MDx initiatives.
NEW YORK (GenomeWeb News) – Meridian Bioscience announced on Tuesday that it its Clostridium difficile assay has been cleared by the US Food and Drug Administration.
Great Basin said this week that it has submitted a 510(k) application to the US Food and Drug Administration for its molecular diagnostic test for Clostridium difficile.
A study of families explores how children transmit SARS-CoV-2, according to the Associated Press.
US Agricultural Research Service scientists have sequenced the genome of the Asian giant hornet.
According to the Economist, pooled testing for COVID-19 could help alleviate strains on testing labs.
In Science this week: MIT researchers outline approach dubbed translatable components regression to predict treatment response among IBD patients.