Lab News
Urgent care centers earn over $400 million 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.
Study finds SARS-CoV-2 antibody kits have varying accuracy
September 25, 2020 -- Commercial SARS-CoV-2 antibody testing kits have a wide variation in sensitivity and specificity, according to a U.K. study published September 24 in PLOS Pathogens.
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.
United Airlines launches pilot COVID-19 testing program
September 24, 2020 -- United Airlines has announced a pilot COVID-19 testing program for travelers in which customers traveling on United from San Francisco International Airport to Hawaii will have the option of taking a rapid COVID-19 test at the airport or a self-collected, mail-in test ahead of the trip.
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.
CMS continues NTAP for T2's bacteria panel in FY 2021
September 23, 2020 -- The U.S. Centers for Medicare and Medicaid Services (CMS) will continue the new technology add-on payment (NTAP) for T2 Biosystems' T2Bacteria panel for the 2021 fiscal year.
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