Danaher on Thursday reported a 6 percent year-over-year increase in third quarter revenues as its subsidiaries see shifting demand for COVID-19-related products, such as diagnostic tests and pharmaceuticals.
The company raised its earnings forecast for 2022 on estimates of $7.8 billion in annual sales related to COVID-19 testing.
Roche’s third-quarter results have revealed a clear sign that the bumper sales boosting companies that have provided products to diagnose, treat or prevent COVID-19 since the start of the pandemic are starting to tail off.
Canadian diagnostics firm MedMira said on Friday that its Vyra COVID-19 Antigen Test has been CE marked and is now available in countries that accept the designation.
The US Food and Drug Administration said Friday it has granted Emergency Use Authorization for Abbott's real-time PCR monkeypox test, the Alinity m MPXV assay.
The US Food and Drug Administration said on Tuesday that it is updating its policy on Emergency Use Authorizations for COVID-19 tests and limiting its review of new submissions.
US Food and Drug Administration officials said Wednesday that over-the-counter molecular assays could bridge gaps in monkeypox testing, as agency officials also continued work on creating guidance specific to antigen tests for the disease.
PerkinElmer subsidiary Oxford Immunotec said Thursday it gained US Food and Drug Administration approval for its T-Cell Select reagent kit that automates sample preparation steps for its tuberculosis in vitro diagnostic assay.
Roche announced on Monday that its Cobas Pure Integrated Solutions instrument has received 510(k) clearance from the US Food and Drug Administration.
DiaSorin said Wednesday it had gained US Food and Drug Administration 510(k) clearance for a swab-based COVID-19 PCR assay that delivers results in about one hour.
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