Lab News
Studies find that coronavirus transmits before symptoms
March 17, 2020 -- The novel coronavirus can spread before patients are symptomatic, according to two new studies, one to be published in the May issue of Emerging Infectious Diseases and the other published March 16 in Science.  Discuss
FDA gives states, vendors more power in coronavirus fight
March 16, 2020 -- In a move it called an "unprecedented policy," the U.S. Food and Drug Administration (FDA) on March 16 once again relaxed its regulations on diagnostics to be used to test for the novel coronavirus. The new rules allow states to regulate diagnostics and let vendors sell tests before getting emergency approval.  Discuss
Coronavirus relief bill omits payment for many lab-developed tests
March 16, 2020 -- The new coronavirus relief bill just passed by the U.S. House of Representatives has drawn fire from the American Association for Clinical Chemistry and other organizations for its omission of coverage for laboratory-developed tests that don't have emergency approval yet.  Discuss
Gottlieb: More coronavirus kits coming, but so is crisis
March 16, 2020 -- More kits to diagnose the coronavirus are going to be available soon, but that doesn't mean the U.S. is out of the woods, according to Dr. Scott Gottlieb, former commissioner of the U.S. Food and Drug Administration. Gottlieb spoke at a webinar on March 13 hosted by Accumen and WIRB-Copernicus Group.  Discuss
FDA grants EUA to Thermo's coronavirus diagnostic test
March 16, 2020 -- The U.S. Food and Drug Administration (FDA) on March 13 granted emergency use authorization (EUA) to Thermo Fisher Scientific for a diagnostic kit to test patients for COVID-19 novel coronavirus disease. Thermo joins Roche among manufacturers with an EUA for a commercial coronavirus test.  Discuss
Trump emergency plan boosts diagnostic testing rollout
March 13, 2020 -- A rapid scale-up of diagnostic testing for the novel coronavirus was the focus of a declaration of emergency by President Donald Trump in a March 13 press conference. The plan calls for sharply boosting the production of coronavirus test kits while also making tests available at a network of drive-through sites.  Discuss
Vendors, labs scramble to meet needs of coronavirus outbreak
March 13, 2020 -- The outbreak of the novel coronavirus is putting a strain on diagnostics manufacturers and clinical labs as they struggle to meet the need for more testing. But vendors and clinicians are optimistic they will gain the upper hand once adequate supplies are procured.  Discuss
ASM: Reagent shortages threaten coronavirus test access
March 13, 2020 -- Shortages in SARS-CoV-2 polymerase chain reaction reagents are threatening access to coronavirus test kits, according to a statement released on March 10 by the American Society for Microbiology (ASM).  Discuss
Study outlines 1st person-to-person coronavirus spread
March 12, 2020 -- A study published March 12 in the Lancet journal describes what is believed to be the first person-to-person transmission of the SARS-CoV-2 virus in the U.S. The incident occurred when an Illinois woman who had traveled to Wuhan, China, was symptomatic.  Discuss
Blood marker may predict kidney transplant failure risk
March 12, 2020 -- French researchers have found that the composition of particular immune cells in the blood a year after a kidney transplant is associated with a patient's risk of transplant failure, according to a study published online March 12 in the Journal of the American Society of Nephrology.  Discuss
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Charlotte, North Carolina United States
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