Reforms in China Affect IVD Companies’ Q3 2025 Earnings

By Mark Terry | From the Volume XXXII, Number 16 – November 17, 2025 Issue

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…

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FDA Has Future Avenues to LDT Oversight

By Scott Wallask | From the Volume XXXII, No. 15 – October 27, 2025 Issue

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…

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Despite Trade Tariffs, IVD Firms Report Upbeat Earnings

By Mark Terry | From the Volume XXXII, No. 12 – August 25, 2025 Issue

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…

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Clinical Labs Battle Complex Claims Denials

By Stephen Beale | From the Volume XXXII, No. 11 – August 4, 2025 Issue

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…

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AMP Reports Provide Crucial Insights for Hiring Managers

By Kristin Althea O’Connor | From the Volume XXXII, No. 9 – June 23, 2025 Issue

IN AN EXCLUSIVE INTERVIEW WITH THE DART REPORT, Somak Roy, MD, chair of AMP’s Clinical Bioinformatician Body of Knowledge Steering Committee, shared best practices that hiring managers at clinical molecular diagnostic laboratories can use to ascertain which candidates could b…

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Labcorp and Quest Discuss Outreach Acquisition Potential

By Scott Wallask | From the Volume XXX, No. 14 – October 2, 2023 Issue

GIVEN THE POTENTIAL UPSIDE OF HUNDREDS OF MILLIONS OF DOLLARS IN ADDED REVENUES, both Labcorp and Quest Diagnostics remain on the prowl to acquire more hospital laboratory outreach …

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IVD Companies Launch New Assays, Analyzers, Automation

By Donna Pocius | From the Volume XXX, No. 12 – August 21, 2023 Issue

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…

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Pharmacogenetic Tests Deliver for Avera Health Lab

By Scott Wallask | From the Volume XXX, No. 6 – April 17, 2023 Issue

CEO SUMMARY: When Avera Institute for Human Genetics wanted to expand its genomics program, it used its past learning with pharmacogenetics to guide the effort. Two key insights? Ask physicians abo…

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CLIA on Path to Recognize Lab Data As a Specimen

By Scott Wallask | From the Volume XXX No. 2 – January 23, 2023 Issue

CEO SUMMARY: Discussions within the federal Clinical Laboratory Improvement Advisory Committee (CLIAC) are focusing on digital diagnostic data and clinical laboratory testing conducted remotely. CLIAC recommendations about these important topics may eventually be part of updates to …

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Eight Macro Trends for Clinical Labs in 2023

By Robert Michel | From the Volume XXX, No. 1 – January 3, 2023 Issue

CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…

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