TAG:
leica biosystems
April 8, 2024, Intelligence: Late-Breaking Lab News
UnitedHealth Group stated that the cyberattack against Change Healthcare, a business unit of UnitedHealth’s Optum division, disrupted processing of approximately $14 billion in claims. The company discovered the cyberattack on Feb. 21 and said it d…
Most IVD Firms Increase Q3 2023 Base Business Revenue
Most in vitro diagnostics (IVD) companies reported increases in base business during the third quarter (Q3) 2023. The numbers, in the single digits, softened the blow from the continuing drop-off in COVID-19 test sales. Manufacturers of tests and laboratory instruments are launching ne…
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…
Despite COVID-19 Losses, IVD Executives Remain Upbeat
Continuing declines in COVID-19 test revenues was a common theme during the first quarte…
Top Public IVD Companies Report Q3/Q4 2022 Earnings
IT WAS A MIXED BAG OF THIRD QUARTER FINANCIAL RESULTS for the nation’s largest in vitro diagnostics (IVD) manufacturers, with COVID-19 testing volume a contributing factor. Fluctuating demand for SARS-CoV-2 testing proved perplexing, as some IV…
Expert Sees Pros, Cons In DP and WSI Systems
CEO SUMMARY: Now that the FDA has cleared two digital pathology systems for use in primary diagnosis, a growing number of pathology groups are taking up the question of whether and when they should adopt and use a digital pathology system and whole slide imaging. One pathologist with hand…
FDA Clears Aperio’s Digital Pathology System
CEO SUMMARY: In May, the FDA announced clearance for Leica Biosystems to market its Aperio AT2 DX System for clinical diagnosis in the United States. The Aperio AT2 DX System is intended for in vitro diagnostic use as an aid to pathologists reviewing and interpreting digital images of sur…
Outside US, Digital Path Moves Ahead Rapidly
CEO SUMMARY: Implementation of digital pathology and whole-slide imaging systems in the United States lags behind that of other countries for two reasons. One is a more acute shortage of pathologists in those countries and the other is a less restrictive regulatory environment. In some lo…
Biggest IVD Manufacturers Report Robust Third Quarter Earnings
In a time of shrinking lab budgets and falling prices for lab tests in the United States, how are the larger in vitro diagnostic (IVD) manufacturers doing? A look at third-quarter financial reports provides useful insights as to which segments within the IVD industry are doing better than ot…
New Company Ready to Heat Up Slow Digital Pathology Market
CEO SUMMARY: There’s a new competitor in the digital pathology marketplace with ambitious plans to deliver a fully-integrated pathologist workflow solution. Inspirata, Inc., of Tampa, Florida, made its debut in March at an international pathology conference. In this exclusive i…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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