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U.S. Food and Drug Administration
IVD Companies Launch New Assays, Analyzers, Automation
By Donna Marie 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…
Pandemic Helped Lab with Hospital Leaders
By Scott Wallask | From the Volume XXX No. 3 – February 13, 2023 Issue
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…
Public IVD Companies Report Q4, Full-Year 2022 Earnings
By Robert Michel | From the Volume XXX No. 3 – February 13, 2023 Issue
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…
Fujifilm Buys Inspirata’s Digital Pathology Assets
By Robert Michel | From the Volume XXX No. 3 – February 13, 2023 Issue
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…
VALID and SALSA Acts Still Pending in Congress
By Scott Wallask | From the Volume XXIX, No. 16 – November 21, 2022 Issue
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:…
Post-COVID: Repurposing Excess PCR Instruments
By Robert Michel | From the Volume XXVIII, No. 15 – November 8, 2021 Issue
CEO SUMMARY: Currently, there are hospital, health system, and independent clinical laboratories that have between two and five different PCR testing platforms. These analyzers were acquired during the pandemic as one way to increase the daily number of SARS-CoV-2 their labs could p…
NeoGenomics Acquires Inivata to Access Liquid Biopsy Technology
By Robert Michel | From the Volume XXVIII, No. 12 – September 7, 2021 Issue
SOME BELIEVE THAT LIQUID BIOPSY TECHNOLOGY has the potential to develop into a Holy Grail of cancer diagnostics. Yet progress in this field has been slow. Now a recent lab acquisition may accelerate the development of clinically-useful liquid biopsies. There is keen interest in how to achieve the …
CURRENT ISSUE

Volume XXX, No. 13 – September 11, 2023
Recent court rulings involving the No Surprises Act are putting the government on the defensive about provisions of the law. Also, the continued consolidation of the IVD and national laboratory company markets has brought more influence to those lab companies. In addition, learn how clinical labs can earn money from their diagnostic data by helping private insurers navigate Medicare Advantage’s risk adjustment model.
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