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clinical laboratory industry
October 5, 2020 Intelligence: Late-Breaking Lab News
Guess who will be partnering with the US Department of Veterans Affairs to support its wider use of digital pathology? It’s Google! Last month, it was announced that the Defense Innovation Unit (DIU) of the Department of Defense (DoD) had selected Google …
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 …
Coming Soon: a Different Clinical Lab Industry
“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…
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 executiv…
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 …
Is HHS Ruling on COVID-19 LDTs Negative for Lab Reimbursement?
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 S…
FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says
This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implic…
HHS ‘Stands Down’ FDA on Its Oversight of LDTs
CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…
Quest Reports 46% Decline in New Cancer Diagnoses in March
ONCE SHELTER-IN-PLACE ORDERS WERE ENACTED IN MARCH because of the COVID-19 pandemic, the number of new diagnoses of cancer declined sharply in the United States. Newly-published data confirms this fact. The data also support the warnings of anatomic pathologists that—because of the pandemi…
August 24, 2020 Intelligence: Late-Breaking Lab News
Currently at least 15 veterinary laboratories in the United States perform COVID-19 tests. This fact was confirmed by Adm. Brett Giroir, MD, the Assistant Secretary of the Department of Health and Human Services (HHS), during an interview last month conducted by CNN. Officials at HHS confi…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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