TAG:
IVD
FDA Issues Proposed Rule to Further Regulate LDTs
CEO SUMMARY: Publication of the FDA’s draft rule on LDT regulation starts the clock on public comment. The proposal seeks to clearly identify laboratory developed tests (LDTs) as in vitro diagnos…
Is Lab and IVD Consolidation Ready to Hit the Wall?
IN HUMAN HISTORY, ALL ERAS COME TO AN END. The majority of the time, the end of an era is disruptive and a new status quo emerges, with different winners and losers. Today, there is growing evidence that one era in c…
IVD and Lab Consolidation Reduces Choices for Labs
CEO SUMMARY: Since the launch of The Dark Report in 1995, consolidation of hospitals, physician groups, clinical labs, pathology groups, and IVD manufacturers has been a major trend every year. Toda…
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…
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 …
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…
Enzo Biochem’s Lab Business Sold to Labcorp for $146M
COMMERCIAL LABORATORY CONSOLIDATION CONTINUES, this time with news earlier this month that New York City-based Enzo Biochem agreed to sell its clinical laboratory business to Labcorp. The deal points to the problem many clinical laboratori…
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. …
CURRENT ISSUE
Volume XXXIII, No. 2 – February 9, 2026
Congress has once again delayed cuts to test reimbursement rates under PAMA, this time until Jan. 1, 2027. Laboratory professionals are urged to lobby Congress to pass the RESULTS act to solve the PAMA cuts problem permanently. Also, patient-driven testing is spurring new opportunities.
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