TAG:
molecular diagnostics
Global IVD Woes in China Should Resonate with US Labs
In vitro diagnostics (IVD) companies reported a mix of overall growth, with many noting continuing challenges in their diagnostics divisions for recent quarterly financial results. Thermo Fisher Scientific, QuidelOrtho, and Danaher reported the…
Crucial Themes Shape 2026 Executive War College
With 2026 now upon us, our attention here at …
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
Reforms in China Affect IVD Companies’ Q3 2025 Earnings
Most of the in vitro diagnostics (IVD) manufacturers that serve clinical laboratories worldwide reported facing financial “headwinds” in the China IVD market that affected their third-quarter performance. This was due to policy changes in the country…
FDA Has Future Avenues to LDT Oversight
CEO SUMMARY: Even though a federal court vacated the FDA’s final rule for laboratory developed tests, experts warn that the agency may still be able to regulate some LDTs via its authority over diagnostic software. An attorney notes that software’s central role in mode…
Deal Offers Signals about the Future of Digital Pathology
THE DIGITAL PATHOLOGY MARKET IS AT AN INFLECTION POINT, AND TEMPUS’ RECENT $81.25 MILLION ACQUISITION OF PAIGE underscores both the challenges and opportunities ahead. While the pandemic temporarily accelerated digital pathology adoption, with vendors raising large su…
Despite Trade Tariffs, IVD Firms Report Upbeat Earnings
LEADING IN VITRO DIAGNOSTICS (IVD) COMPANIES RECENTLY REPORTED POSITIVE QUARTERLY FINANCIALS despite swirling concerns about trade tariffs and cuts to US federal research grants. It’s not yet clear what the long-term effect of tariffs’ will be on IVD manu…
Clinical Labs Battle Complex Claims Denials
CEO SUMMARY: While the number of denials is not going up, the reasons that private payers deny claims are becoming more complex and time-consuming to appeal. After reviewing noteworthy trends among payers, learn a three-level approach to appeals that may lead to greater su…
Don’t Let the Payers Enjoy All the Benefits of Data
PROBABLY SINCE THE ADVENT OF M…
AI Hype in Labs: 6 Tips to Sniff Out the BS
CEO SUMMARY: In the final entry of our artificial intelligence series, the co-founders of Sample Healthcare discuss how clinical labs can evaluate AI vendors effectively, with an emphasis on assessing technical credentials and quick proofs of concept. Armed with the right …
CURRENT ISSUE
Volume XXXIII, No. 5 – April 13, 2026
Another integrated delivery network mega-deal has been proposed, with California’s Sutter Health planning a merger with Minnesota’s Allina Health. Also, refunds for President Trump’s illegal tariffs may be forthcoming for IVD importers, but it will be a struggle.
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