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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

Clinical Laboratory Trends / By Robert Michel

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

In Vitro Diagnostics / By Robert Michel

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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Is HHS Ruling on COVID-19 LDTs Negative for Lab Reimbursement?

Laboratory Compliance / By Robert Michel

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 downside—difficulty getting reimbursed for the test. On Aug. 19, the Department of Health and Human Services (HHS) issued a new directive that said clinical laboratories are no longer required to obtain an EUA from the Food …

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Labs Adjust to COVID-19 as a Regular Part of Care

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

ONE INTERESTING NEW DEVELOPMENT NOT REPORTED MUCH BY THE NATIONAL MEDIA is that the daily number of new COVID-19 cases in the United States has declined steadily in the past month. It is too early to understand the implications of this development, but clinical lab administrators and pathologists may want to follow a basic statistic. Here at The Dark …

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Amazon Targets COVID-19 Testing in its New Lab-Building Venture

TDR Insider / By Robert Michel

This is an excerpt of a 1,980-word article in the August 3, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent COVID-19 testing venture for employees could be a significant concern given that the e-commerce company could disrupt …

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COVID-19 Changes Lab and Pathology Profession

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

WE ARE ENTERING THE SEVENTH MONTH OF THE SARS-COV-2 OUTBREAK and some public health authorities predict that new cases of COVID-19 will continue through the fall and into 2021. If true, this will not be auspicious for the nation’s clinical laboratories and anatomic pathology groups. The current clinical and business model of clinical laboratory and anatomic pathology operations …

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Amazon Building Labs to Do COVID-19 Testing

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent lab-testing venture for employees could be a significant concern given that the e-commerce company could disrupt the clinical lab business nationwide. The online retail giant has long had an interest in medical diagnostics and has a reputation for disrupting other industries by acquiring or starting companies in such diverse fields as …

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IVD Firms Report Boom in Sales of COVID-19 Instruments, Tests

In Vitro Diagnostics / By Robert Michel

Because of the COVID-19 pandemic, second quarter earnings reports were a good news/bad news situation for most of the nation’s major in vitro diagnostic (IVD) companies. The good news was that demand for COVID-19 tests meant increased sales and revenues for IVD firms selling those products. But the collapse in routine lab testing that happened in March, April, May, and June was bad news …

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Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?

TDR Insider / By Robert Michel

This is an excerpt of a 1,420-word article in the July 13, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled testing for COVID-19 could be a double-edged sword for clinical labs and in vitro diagnostics companies. Offering the advantage of reducing the number …

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Search Results for: COVID-19