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U.S. Food and Drug Administration

Global IVD Companies Report Second Quarter 2024 Earnings

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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Clarapath Raises $36 Million for Automated Histology Solution

AS THE HISTOLOGY WORKFORCE STRUGGLES TO KEEP UP WITH RISING CASE DEMAND, Clarapath—a Hawt…

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Identifying Current Lab Trends from Labcorp & Quest Experience

CEO SUMMARY: Many different factors influence the operations of clinical laboratories in the United States today. One good source of competitive business intelligence is for lab administrators to follow the quarterly earnings calls of the nation’s two biggest public lab corporations. Wi…

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How Private Health Insurers May Respond to FDA LDT Regulation

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Q3 2023 Financial Reports Show Growth at Labcorp, Quest

Blood brothers Labcorp and Quest Diagnostics showed momentum beyond COVID-19 testing and toward areas that grew base business revenue in their third quarter (Q3) 2023 financial reporting. Company leaders called attention to more partnerships and acquisitions of ho…

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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…

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Pandemic Helped Lab with Hospital Leaders

CEO SUMMARY: Growth at Atrium Health during the COVID-19 pandemic elevated its clinical laboratory’s profile with medical leaders and health system administrators. What followed was a new spirit of collaboration that led to lab involvement in cost savings efforts, such as improved…

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Public IVD Companies Report Q4, Full-Year 2022 Earnings

YEAR-END AND Q4 EARNINGS REPORTS FROM MAJOR IN VITRO DIAGNOSTICS (IVD) COMPANIES pointed to a welcome sign of core diagnostic business rebounding.  That’s the good news for IVD firms. The bad news? All of the SARS-CoV-2 testing revenue that th…

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Fujifilm Buys Inspirata’s Digital Pathology Assets

CEO SUMMARY: Fujifilm’s acquisition of the digital pathology technologies and clients of Inspirata marks the departure of one early entrant into the digital pathology market. At the same time, executives from Fujifilm Healthcare Americas Corporation discuss why the company is incr…

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VALID and SALSA Acts Still Pending in Congress

CEO SUMMARY: Both the pending VALID Act and SALSA Act continue to push ahead as 2022 comes to an end. Meanwhile, a new bill centered on the Physician Fee Schedule may protect pathologist payments. These three different proposals share something in common:…

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