Volume XXVII No. 13 - September 14, 2020 Archives

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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Coming Soon: a Different Clinical Lab Industry

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

“Keep your eye on the ball” is an idiom that originated with baseball. The idea is that every player on the field should, at all times, know where the ball is so that they can be ready to do their job when the ball comes their way. This is excellent advice for clinical lab administrators and pathologists during …

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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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Franciscan Missionaries Sells Lab Outreach Business to LabCorp

Laboratory Management / By Robert Michel

SINCE THE ONSET OF THE PANDEMIC IN LATE FEBRUARY, the nation’s two largest clinical lab companies have announced only two acquisitions of hospital laboratory outreach programs, one in June and one this month. Last week, LabCorp announced its acquisition of the clinical ambulatory laboratory business of Franciscan Missionaries of Our Lady Health System (FMOLHS) in Baton Rouge, La. Earlier, on June 23, Quest Diagnostics …

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New York Firm to Build CLIA Labs in Shipping Containers

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: In many respects, the COVID-19 pandemic is like a gold rush for entrepreneurs. Federal and state governments, colleges, employers, school districts, and other entities need COVID-19 tests and tens of billions of dollars are available to pay for such tests. This modern gold rush has encouraged companies such as Amazon and Alphabet/Google to build their own clinical labs. Now …

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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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September 14, 2020 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

Alphabet, Inc., the parent of Google, is expanding its COVID-19 testing activities. In recent months, Verily Life Sciences—a division of Alphabet devoted to research into life sciences—organized a clinical laboratory for COVID-19 testing. It obtained CLIA certification and is licensed with the State of California. In a blog, Verily’s Head of Pathology, Deb Hanks, MD, wrote that the lab had “verified the performance of the SARS-CoV-2 RT-PCR test …

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Issue: Volume XXVII No. 13 - September 14, 2020