TAG:
COVID-19
Texas Company Operates 400 COVID-Collection Sites
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
CEO SUMMARY: In April, the federal Department of Health and Human Services contracted with eTrueNorth to operate COVID drive-through specimen-collection sites under the Community-Based Testing Sites program. The drive-through sites are an extension of non-COVID testing the company has …
New York Firm to Build CLIA Labs in Shipping Containers
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
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 gol…
Is HHS Ruling on COVID-19 LDTs Negative for Lab Reimbursement?
By Robert Michel | From the Volume XXVII No. 13 – September 14, 2020 Issue
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
By R. Lewis Dark | From the Volume XXVII, No. 12 – August 24, 2020 Issue
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…
Specimen Volume Returns at Dallas-based ProPath
By Robert Michel | From the Volume XXVII, No. 12 – August 24, 2020 Issue
CEO SUMMARY: Like other physician specialties, anatomic pathology saw a dramatic collapse in the number of daily procedures with a corresponding decline in cash flow as the COVID-19 pandemic hit with full force in March, April, and May. The good news is that the daily volume of tissue…
Quest Reports 46% Decline in New Cancer Diagnoses in March
By Robert Michel | From the Volume XXVII, No. 12 – August 24, 2020 Issue
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…
Wisconsin Lab Network Feeds Valuable Data to State Health Lab
By Robert Michel | From the Volume XXVII, No. 12 – August 24, 2020 Issue
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
By Robert Michel | From the Volume XXVII, No. 12 – August 24, 2020 Issue
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…
CMS Publishes Proposed 2021 Medicare Physician Fee Schedule
By Robert Michel | From the Volume XXVII, No. 12 – August 24, 2020 Issue
MEDICARE’S PROPOSED PHYSICIAN FEE SCHEDULE (PFS) rule was announced on Aug. 4, 2020. The rule had one positive development for clinical laboratories and hospital laboratory outreach programs and a negative development for anatomic pathologists. Clinical laboratories and hospital outreach lab…
August 24, 2020 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVII, No. 12 – August 24, 2020 Issue
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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