TAG:
IVD
Siemens Healthineers Plans to Streamline Product Offerings
By Scott Wallask | From the Volume XXX, No. 1 – January 3, 2023 Issue
DURING A 15-MONTH STRETCH FROM 2006-2007, Siemens Healthineers spent $14 billion to acquire three competing companies and their various technologies. Today, Siemens is preparing to sunset as many as half of its legacy instruments and assays, whic…
2022’s Top 10 Lab Stories Confirm Challenging Times
By Scott Wallask | From the Volume XXIX, No. 17 – December 12, 2022 Issue
CEO SUMMARY: There are valuable insights to be gleaned from The Dark Report’s “Top 10 Lab Industry Stories for 2022.” Several of this year’s story picks involve external forces reshaping healthcare in the United States in profound ways. Other story picks for 2022 illustrate …
Top Public IVD Companies Report Q3/Q4 2022 Earnings
By Robert Michel | From the Volume XXIX, No. 17 – December 12, 2022 Issue
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…
Babson Diagnostics’ Hybrid Model Combines Quality, Convenience
By Robert Michel | From the Volume XXIX, No. 16 – November 21, 2022 Issue
CEO SUMMARY: Responding to its own data about consumer preferences, healthcare technology company Babson Diagnostics is pursuing a new hybrid model for blood draws that it believes brings together the best of clinical laboratories and retail pharmacies. Laboratory managers and patho…
Reports Say Qiagen and Bio-Rad Discussing Potential IVD Merger
By Scott Wallask | From the Volume XXIX, No. 15 – October 31, 2022 Issue
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
By Scott Wallask | From the Volume XXIX, No. 14 – October 10, 2022 Issue
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 …
2021 Rankings of the World’s Top 12 IVD Companies
By Robert Michel | From the Volume XXIX, No. 12 – August 29, 2022 Issue
WHILE THERE WAS SOME JOCKEYING FOR NEW positions, in vitro diagnostics (IVD) manufacturers remain entrenched in their market based on The Dark Report’s 2021 ranking of the Top 12 IVD Companies. COVID-1…
Public Laboratory Companies Eye More Lab Outreach Acquisitions
By Robert Michel | From the Volume XXIX, No. 12 – August 29, 2022 Issue
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…
News and Insights from AACC Meeting in Chicago
By Robert Michel | From the Volume XXIX, No. 11 – August 8, 2022 Issue
CEO SUMMARY: There was plenty of positive energy last month when the 72nd Annual Scientific Meeting and Exhibition of the American Association of Clinical Chemistry (AACC) took place in Chicago. Attendees seemed pleased to be gathering and networking in person. However, there was re…
Coverage, Reimbursement Still Difficult for New Lab Tests
By Robert Michel | From the Volume XXIX, No. 11 – August 8, 2022 Issue
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,…
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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