Search Results for: COVID-19

NorDx Lab Started to Prepare for COVID-19 Testing in 2019

CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testing and past epidemics, the president of NorDx Laboratories in Maine saw the December news accounts of a widespread outbreak of a new respiratory disease in China. He warned his lab team to assume the worst and energized them to …

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COVID-19 or Not, Lab Market Enters ‘Twilight Zone’

Our healthcare system is in a most remarkable state. Even as all providers—including clinical laboratories and anatomic pathology groups—continue to devote considerable resources to meeting the urgent need for SARS-CoV-2 testing, health insurers and regulators continue to issue new requirements governing all aspects of “normal” lab testing activities.  Today, all clinical labs and pathology groups …

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NY Hospital Lab Succeeds with Pooled COVID-19 Testing

CEO SUMMARY: Pooled testing helps the clinical lab staff at the hospital in Saratoga Springs, N.Y., do more COVID-19 tests when supplies might otherwise run short. Lab managers estimate this method has saved 5,000 test cartridges since May. Pooled testing also helps the physician staff in the emergency department identify patients who may be positive …

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CLIA Lab Inspections Different Because of COVID-19 Pandemic

WITH THE ONSET OF THE COVID-19 PANDEMIC IN MARCH, three of the major organizations deemed to have CLIA status suspended inspections of clinical laboratories for several months. Inspections and assessments of laboratories have restarted, but with significant changes because of the SARS-CoV-2 outbreak.  These changes to the CLIA lab assessment and accreditation process were the …

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Lab Leaders Say COVID-19 Tests Needed in 2021

How long into the future will clinical laboratories need to offer COVID-19 tests on a large scale? That is the number one question confronting labs in every region of the United States. Last week, three nationally-known lab CEOs answered that question during the general session of the Virtual Executive War College. It was a panel discussion moderated by Robert …

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High-Complexity Mobile Labs for COVID-19 Testing

CEO SUMMARY: Demand for high-complexity mobile coronavirus testing facilities is high, according to the CEO of a start-up company building 25 clinical labs in mobile trailers that can do hundreds of tests per eight-hour day. Employers, schools, event organizers, and other entities all have high interest in contracting with this California company for mobile on-site testing that can deliver rapid results …

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Will HHS Ruling on COVID-19 LDTs Be Good or Bad for Lab Reimbursement?

This is an excerpt of a 1,028-word article in the September 14, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. WHILE SOME LABS CELEBRATE THE PERCEIVED FLEXIBILITY that comes from not having to get an emergency use authorization (EUA) for COVID-19 laboratory-developed tests (LDTs), there is a potential …

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Understanding COVID-19’s Changes to Lab Industry

CEO SUMMARY: With the SARS-CoV-2 pandemic about to enter its eighth month in the United States, it remains difficult to predict whether the pandemic will strengthen with the fall influenza season or steadily diminish. What is clear to most pathologists and clinical laboratory executives is that the COVID-19 pandemic has already changed several aspects of how laboratories select suppliers, purchase supplies, …

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Covid-19 Pandemic May Be Creating New IVD Winners and Losers

WITH THE PANDEMIC NOW IN ITS NINTH MONTH, in vitro diagnostics (IVD) company executives and industry consultants recognize the market for clinical laboratory instruments, tests, and products is changing in fundamental ways. “Evidence accumulates that the pandemic is helping create new winners and new losers among big and little IVD companies,” stated Peter van Overwalle, who is Head of Marketing and Partner at LiquidSMARTS …

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