Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

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Food and Drug Administration

Significant Developments Are Shaping Lab Market

CEO SUMMARY: With 140 speakers and 1,000+ attendees, this year’s Executive War College again provided a comprehensive picture of the specific forces reshaping the U.S. market for lab testing services. Presented here is a smorgasbord of information and innovation shared by different spea…

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FDA Hosts Webinar to Explain Key Issues with Final LDT Rule

  ON APRIL 29. THE US FOOD AND DRUG ADMINISTRATION (FDA) announc…

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Labcorp, Quest Issue Q1 Earnings, Offer Comments on FDA’s LDT Rule

  BOTH LABCORP, BURLINGTON, N.C., AND QUEST DIAGNOSTICS, SECAUCU…

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New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks

CEO SUMMARY: There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 ho…

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Congressional Subcommittee Hears Testimony on FDA LDT Rule

DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…

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Lab Market Fragmenting, Creating New Opportunities

CEO SUMMARY: Even as consolidation continues in the ownership of hospitals, health systems, office-based physicians, and clinical laboratories, there is a powerful trend of fragmentation quietly transforming the way providers—including clinical labs and pathology groups—serve patient…

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FDA Issues Memo to Reclassify Many High Risk IVD Assays

WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…

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Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings

DURING RECENT EARNINGS CALLS WITH FINANCIAL ANALYSTS AND INVESTORS, both Labcorp and Quest Diagnostics discussed their fourth quarter (Q4) and full year 2023 financial results. Each reported some stability in the market for clinical laboratory testing services, reflected in the numbe…

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Labs Should Prepare for Arrival of ‘Perfect Storm’

CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…

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CMS Issues AI Guidance for Medicare Advantage

CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal governme…

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