TAG:
QuidelOrtho
Most IVD Firms Increase Q3 2023 Base Business Revenue
Most in vitro diagnostics (IVD) companies reported increases in base business during the third quarter (Q3) 2023. The numbers, in the single digits, softened the blow from the continuing drop-off in COVID-19 test sales. Manufacturers of tests and laboratory instruments are launching ne…
IVD Companies Launch New Assays, Analyzers, Automation
Steep declines in SARS-CoV-2 test revenue were reported by the top in vitro diagnostics (IVD) companies in Q2 2023 earnings compared to a year earli…
August 21, 2023, Intelligence: Late-Breaking Lab News
New research about ownership of physician practices will be of interest to anatomic pathologists who operate their own businesses. According to an analysis by the American Medical Association (AMA),…
2022 Ranking of the World’s Top 12 IVD Corporations
WHILE THE TOP FOUR IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS kept their collective hold on the market compared to 2021, the big surprise was that Thermo Fisher Scientific’s…
July 31, 2023, Intelligence: Late-Breaking Lab News
Regulatory relief is on the way for clinical laboratories accredited by The Joint Commission. An overhaul of the Laboratory Accreditation Program’s standards, which goes into effect Aug. 27, will …
July 10, 2023, Intelligence: Late-Breaking Lab News
General health panels submitted under CPT code 80050 are among the most expensive—and potentially most wasteful—diagnostic tests, according to a new study published in June by Avalo…
Despite COVID-19 Losses, IVD Executives Remain Upbeat
Continuing declines in COVID-19 test revenues was a common theme during the first quarte…
IVD Firms Prepare for OTC, Home Test Market Expansion
CEO SUMMARY: With public interest in home testing growing, some IVD manufacturers are preparing to serve a fast-expanding market for over-the-counter and at-home tests. IVD firms are banking on the…
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. …
2022’s Top 10 Lab Stories Confirm Challenging Times
CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …
CURRENT ISSUE
Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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