TAG:
COVID-19 test
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…
Labs Adjust to COVID-19 as a Regular Part of Care
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…
Wisconsin Lab Network Feeds Valuable Data to State Health Lab
CEO SUMMARY: From the earliest days of the COVID-19 pandemic, the 138-member Wisconsin Clinical Laboratory Network has reported to the state health lab the number of COVID-19 tests, the number of positive results, as well as other data that includes data on lab testing supplies and ca…
Thermo–Qaigen Merger Stopped, More IVDs Report Q2 Earnings
EACH TIME A MAJOR IN VITRO DIAGNOSTICS (IVD) COMPANY reports its quarterly earnings, clinical lab executives and pathologists gain useful new perspectives as to how the COVID-19 pandemic is fueling demand for IVD instruments, tests, and lab consumables. In this round-up of the most r…
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…
Amazon Targets COVID-19 Testing in its New Lab-Building Venture
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 t…
Amazon Building Labs to Do COVID-19 Testing
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 medic…
Employers, Others Looking to Build New Clinical Labs
CEO SUMMARY: Employers, universities, municipalities, and other large organizations are interested in building their own clinical laboratories. In addition, entrepreneurs—many with no prior experience in laboratory medicine—want to make money providing COVID-19 testing. Many of th…
Is COVID-19 Pooled Testing Good for Labs, Bad for IVDs?
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 diagnos…
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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