IVD/Lab Informatics
Reports Say Qiagen and Bio-Rad Discussing Potential IVD Merger
More consolidation in the in vitro diagnostics (IVD) market may soon happen. Bio-Rad Laboratories and Qiagen are reportedly in merger discussions. The Wall Street Journal, which broke the story on Oct. 10, tabbed the potential deal as being worth …
Thermo Fisher Expands Menu to Offset COVID-19 Decreases
IT’S NOT JUST CLINICAL LABORATORIES seeking ways to repurpose the analyzers and automation they used to perform SARS-CoV-2 testing. As the pandemic continues to ease, some in vitro diagnostics (IVD) companies want to help their lab customers by expanding the types of diagnostic tests than can …
Public Laboratory Companies Eye More Lab Outreach Acquisitions
PUBLICLY-TRADED CLINICAL LABORATORY COMPANIES released second quarter 2022 financial reports that confirmed a softening demand for COVID-19 tests, even as their base business revenues grew compared to last year. While continuing to address ongoing needs…
Coverage, Reimbursement Still Difficult for New Lab Tests
CEO SUMMARY: Bringing a new proprietary diagnostic test to market is an arduous process. It takes patience and planning to complete the journey from test development to payer reimbursement. This slow process stems from the fact that the healthcare reimbursement system is fragmented,…
Pandemic Complicates Sales for Lab Info System Companies
HEALTHCARE INFORMATION TECHNOLOGY (IT) COMPANIES serving clinical laboratories and providers with laboratory information systems (LISs) and electronic health records (EHRs) shared recent financial reports on their businesses. It is challenging to obtai…
IVD Firms Report Strong Growth Because of COVID-19 Testing
TO NO ONE’S SURPRISE, THOSE IN VITRO DIAGNOSTICS (IVD) MANUFACTURERS that produce molecular tests, instruments, and automation used for COVID-19 testing reported strong growth in revenue and profits during 2020. In recent weeks, these companies issued t…
Truvian Sciences Raises $105M for Near-Patient Lab Test System
DESPITE THE PANDEMIC, investors continue to support emerging in vitro diagnostics (IVD) companies. This is particularly true of start-up companies that want to develop clinical lab testing systems that can be used at the point of care, that require small amounts of blood, and that deliver accu…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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