Some at-home infectious disease tests and sample collection kits exist in a murky regulatory realm, and their sale to patients is troubling laboratorians and clinicians.
The collaboration between 15 federal and state groups used a workshop format originally developed by CDC to help other countries with their One Health issues.
GenMark Diagnostics received clearance for a third BCID panel that the firm said paves the way for a customizable approach to sepsis MDx.
Flu test sales were the second-highest for a quarter in the firm's history but were still $17.4 million lower than the year-ago quarter due to a much less intense flu season.
The in vitro diagnostic is designed to detect whole gene segments for influenza A and B viruses and can characterize viruses as seasonal or nonseasonal.
Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.
The spread of POC testing technology along with changes in state regulations and pharmacist education are driving an increase in pharmacist-administered testing.
Since moving to rapid molecular testing, the lab has doubled its billable test volume, largely through increasing clients for its outreach lab services.
The firm said that its rapid flu detection platform helps reduce the subjectivity of interpreting test results and can be used in a broad range of healthcare settings.
The firm’s test for detecting flu and differentiating between subtypes A and B is being launched in Europe, Asia, and South America.