CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 2023—BioGx announced accelerated adoption of its high-performance Sample-Ready PCR assay for the detection of Candida auris. A complete PCR mix is provided in a single lyophilized tube format to be validated by laboratories on a variety of real-time PCR instruments, including the BD Max, Thermo Fisher QuantStudio, Bio-Rad CFX Touch, and BioGx Pixl platform. The company says its assay has been successfully validated and implemented by public health laboratories and hospitals in several states.
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BD, BioGX announce FDA EUA for COVID-19 dx
April 3, 2020—BD and BioGX announced that the FDA has granted emergency use authorization for a diagnostic test that will enable hospitals to screen for COVID-19 on site and get results in less than three hours.
Read More »BD, BioGX announce EUA submissions for COVID-19 dx
March 18, 2020—BD and BioGX have submitted emergency use authorization requests to the FDA for new diagnostic tests that, if authorized, would increase the potential capacity to screen for COVID-19 by thousands of tests per day. The tests will be run on the BD Max molecular diagnostic platform, which can process 24 samples simultaneously.
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