TAG:
COVID-19 test
Global IVD Companies Report First Quarter 2024 Earnings
IN THEIR INITIAL FINANCIAL REPORTING F…
QuidelOrtho Earns $3.3 Billion in First Year as Combined Firm
IN OUR FEBRUARY 13, 2023, ISSUE OF THE DARK REPORT, we analyzed the 2022 full-year and Q4 earnings of major IVD companies. At the time our prior issue went to press, QuidelOrtho had not yet reported its year-end results. …
Whistleblower Lab Manager Files Response to PerkinElmer Lawsuit
IN A DAVID-VERSUS-GOLIATH-LIKE BATTLE, perhaps the most unusual lawsuit in decades involving clinical laboratory operations and compliance is unfolding in a federal courthouse in California. In this case, a multi-billion-dollar in vitro diagnostics (IVD) company is suing a laboratory manager w…
June 14, 2021 Intelligence: Late-Breaking Lab News
Is it possible to use a genetic test to predict an individual’s risk of severe infection requiring hospitalization or death from SARS-CoV-2? That is the claim of Australian-based molecular diagnostics company Genetic Technologies Limited. It recently announced an agreement with U.S.-based …
Predicting Future Demand for COVID-19 Testing
CEO SUMMARY: After 15 months of the pandemic, the nation’s clinical laboratories are at an interesting crossroads. Is the COVID-19 outbreak diminishing and close to disappearing? Or might it intensify again, particularly when the traditional influenza season arrives next fall? The…
Amazon Sells COVID-19 Test Kit for At-Home Use by Consumers
QUIETLY AND WITHOUT MUCH ATTENTION, online retailing giant Amazon began to sell a COVID-19 molecular test to consumers for at-home testing. This is consistent with other actions Amazon has taken to generate revenue during the SARS-CoV-2 pandemic. …
IVD Firms Report Strong Growth Because of COVID-19 Testing
TO NO ONE’S SURPRISE, THOSE IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS that produce molecular tests, instruments, and automation used for COVID-19 testing reported strong growth in revenue and profits during 2020. In recent weeks, these companies issued t…
April 12, 2021 Intelligence: Late-Breaking Lab News
One clinical laboratory company now says it provides COVID-19 testing services to all five of the major men’s professional sports leagues in the United States. On April 1, BioReference Laboratories, Inc. (BRLI), a division of Opko Health, announced a new agreement with Major League…
What Comes Next? Predictions on COVID-19 Test Volumes in 2021-22
CEO SUMMARY: Incoming data show that the number of referrals for both COVID-19 tests and routine tests is in a decline that started in October and is continuing. This complicates the strategic planning for hospital/health system labs, independent labs, and pathology groups. They nee…
Might Politics Sway California Lab’s CLIA Compliance?
IS IT A CONFLICT FOR A STATE GOVERNMENT TO BUILD AND OPERATE A CLIA high-complexity clinical laboratory and have the same department that manages this lab facility also conduct the CLIA-mandated inspections and oversight of the lab’s compliance, as required by the federal Clinical Laboratory Improv…
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.
The Dark Report • 21806 Briarcliff Dr • Spicewood, TX 78669
Phone: 512-264-7103 • Toll Free Number: 800-560-6363
Email: info@darkreport.com
© 2024 The Dark Report. All rights reserved.