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.
Rapid point-of-care COVID-19 test shows promise in clinical study
September 18, 2020 -- A rapid COVID-19 test that can produce results at the point of care in just 90 minutes without sending samples to a central lab has demonstrated 94% sensitivity and 100% specificity, according to a new study published in the Lancet Microbe.  Discuss
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.
Qiagen to launch rapid portable SARS-CoV-2 antigen test
September 10, 2020 -- Qiagen plans to launch the Access Anti-SARS-CoV-2 antigen test, a rapid portable test that can detect novel coronavirus antigens in people with active infections in less than 15 minutes.
BillionToOne wins EUA for RNA extraction-free COVID-19 test
September 9, 2020 -- Diagnostics firm BillionToOne has received emergency use authorization (EUA) from the U.S. Food and Drug Administration for its qSanger-COVID-19 assay, a SARS-CoV-2 test that obviates the need for RNA extraction.
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.