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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Deal Offers Signals about the Future of Digital Pathology

By Janette Wider | From the Volume XXXII, No. 13 – September 15, 2025 Issue

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…

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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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Don’t Let the Payers Enjoy All the Benefits of Data

By R. Lewis Dark | From the Volume XXXII, No. 11 – August 4, 2025 Issue

PROBABLY SINCE THE ADVENT OF M…

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AI Hype in Labs: 6 Tips to Sniff Out the BS

By Scott Wallask | From the Volume XXXII, No. 11 – August 4, 2025 Issue

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 …

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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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COLA Summit to Address Lab Staffing Shortages

By Robert Michel | From the Volume XXXII, No. 5 – March 31, 2025 Issue

CEO SUMMARY: An upcoming gathering of COLA’s Workforce Action Alliance will focus on three staffing challenges: improving data needed to understand the current clinical laboratory workforce; promoting career paths for new professionals in the field; and identifying ways …

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Global IVD Companies Issue Third Quarter 2024 Earnings

By Robert Michel | From the Volume XXXI, No. 16 – November 25, 2024 Issue

HERE IS A SUMMARY OF THE THIRD QUARTER FINANCIAL PERFORMANCE of t…

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Global IVD Companies Report Second Quarter 2024 Earnings

By Robert Michel | From the Volume XXXI, No. 13 – September 23, 2024 Issue

IN THE SECOND QUARTER OF 2024, in vitro diagnostics (IVD) companies reported solid revenues as well as new tests, analyzers, and automation. Most of the IVD companies boosted diagnostic sales in low single digit amounts. During the earnings calls, financial analysts asked company leade…

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