Quadrant wins EUA for COVID-19 saliva test September 24, 2020 -- Quadrant Biosciences has received emergency use authorization (EUA) from the U.S. Food and Drug Administration for its Clarifi COVID-19 test kit.
BD seeks FDA OK to use more samples with HPV test September 23, 2020 -- Becton Dickinson (BD) has asked the U.S. Food and Drug Administration (FDA) to make the ThinPrep Pap Test PreservCyt Solution vial an approved sample for its Onclarity HPV Assay.
Hoth, GW partner to develop mobile COVID-19 test September 21, 2020 -- Clinical-stage biopharmaceutical company Hoth Therapeutics and George Washington University (GW) have partnered to create a device that allows health professionals to diagnose COVID-19 with a mobile device.
LuminUltra submits COVID-19 diagnostic for approval September 14, 2020 -- Molecular diagnostics company LuminUltra has submitted its GeneCount COVID-19 assay for emergency use authorization with the U.S. Food and Drug Administration. The Canada-based company also submitted an interim order with Health Canada.
Top companies earn 80% of revenue in IVD market September 11, 2020 -- Most of the revenue in the IVD market is generated by fewer than 20 companies, according to a recent report by IVD market research firm Kalorama Information, a sister company of LabPulse.com, explains Bruce Carlson of Kalorama. Discuss
ProciseDx wins CE Mark for point-of-care tests September 10, 2020 -- Nestlé Health Science subsidiary ProciseDx has received the European CE Mark for Procise IFX and Procise ADL, the company's infliximab and adalimumab point-of-care diagnostics.
LabCorp debuts combined COVID-19, flu, and RSV test September 9, 2020 -- LabCorp has launched a combined test for COVID-19, influenza A/B, and respiratory syncytial virus (RSV). The single-panel test is now available throughout the U.S. through doctors, hospitals, and other authorized healthcare providers.