Lab News
Biocept reaches COVID-19 testing milestone
October 6, 2020 -- Biocept said that it has received more than 50,000 COVID-19 specimens for processing at its molecular laboratory.
San Diego lab agrees to pay $3M in fraud case
October 5, 2020 -- San Diego-based drug testing firm Phamatech and its founder and CEO Tuan Pham have agreed to pay $3 million to settle Medicare fraud claims.
LabCorp nabs EUA for new COVID-19 molecular test
October 5, 2020 -- The U.S. Food and Drug Administration has awarded LabCorp emergency use authorization (EUA) for a new, high-throughput method that uses heat and technology to extract RNA from COVID-19 samples.
Rover's rapid COVID-19 test advances to phase I of RADx
October 2, 2020 -- The U.S. National Institutes of Health has selected a COVID-19 rapid test from Rover Diagnostics and Columbia Engineering for phase I of the Rapid Acceleration of Diagnostics (RADx) initiative.
FDA grants Beckman Coulter EUA for assay test
October 2, 2020 -- The U.S. Food and Drug Administration (FDA) has awarded Beckman Coulter emergency use authorization (EUA) for its Access Interleukin-6 assay.
Urgent care centers earn over $400M from COVID-19 testing
October 1, 2020 -- With approximately 10,000 urgent care locations across the country and more than three-fourths of the U.S. population residing within a 10-minute drive of one, the urgent care market is expected to grow, writes Bruce Carlson of Kalorama Information, a sister company of  Discuss
PerkinElmer newborn screening test gets CE Mark
September 30, 2020 -- PerkinElmer has received the CE Mark for its reverse transcription polymerase chain reaction newborn screening assay.
FDA issues EUA for OralDNA's oral rinse COVID-19 test
September 30, 2020 -- The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for OraRisk, a saline oral rinse COVID-19 test from OralDNA Labs. OraRisk is a reverse transcription polymerase chain reaction test that is the first saline 30-second swish and gargle collection COVID-19 test to get an EUA.
CMS debuts new guide to streamline CLIA process for COVID-19
September 25, 2020 -- The U.S. Centers for Medicare and Medicaid Services (CMS) has released new tools to streamline the process for labs seeking CLIA certification to test for COVID-19.
Biovica files 510(k) submission for breast cancer test
September 25, 2020 -- Biovica has filed a 510(k) submission with the U.S. Food and Drug Administration for its DiviTumTKa breast cancer test.
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