bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the addition of Anterior Nasal Swab (ANS) as a validated specimen type for this panel, specifically for use with the respiratory test menu. By swabbing only the anterior part of the nasal cavity, ANS provides significantly more comfort for the patient.
Roche on Monday announced that its Cobas Respiratory 4-flex test for SARS-CoV-2, influenza A/B, and respiratory syncytial virus has received clearance from the US Food and Drug Administration.
Diasorin (FTSE MIB: DIA) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the second1 of its 3 multiplex molecular panels for blood culture pathogen identification on the LIAISON PLEX® system.
BioMérieux announced Tuesday that its multiplex Biofire Spotfire Respiratory/Sore Throat Panel has received Health Canada approval.
CDC continues to expect the respiratory disease season will have a similar or lower number of combined peak hospitalizations due to COVID-19, influenza, and RSV compared to last season. This update assesses when peak hospital demand may occur. CDC will update this outlook again in February or as warranted by substantial changes in the spread of any of the three diseases.
Pertussis is a highly contagious acute respiratory disease that can last for several months and often causes epidemics.
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Respiratory Panel Mini test for clinical use. It is the third test to receive FDA clearance for use with QIAstat-Dx systems in 2024.
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE-marking under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR).
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of the cobas® Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology.
China's respiratory testing market shows significant growth potential, driven by increasing demand, technological advancements, supportive policies, and a growing market size.
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