TAG:
IVD
IVD Companies Report Record Sales as 2021 Draws to Close
JUDGING BY THE THIRD QUARTER FINANCIAL PERFORMANCE of the major in vitro diagnostics (IVD) manufacturers, the demand for COVID-19 testing continues to generate a substantial stream of revenue. During their respective conference calls with investo…
Congress May Soon Act on LDT, IVCT Regulation
CEO SUMMARY: Congress is gearing up for a debate on how to regulate laboratory-developed tests (LDTs) and other in vitro clinical tests (IVCTs). The VALID Act sets the stage for the FDA to take a greater role in pre-market review of LDTs, and the VITAL Act proposes to keep those tes…
Congress May Soon Act on IVCT, LDT Regulation
This is an excerpt of a 2,017-word article in the November 29, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Congress is gearing up for a debate on …
It’s Flu Season and COVID-19 Cases Continue
SUBSTANTIAL NUMBERS OF NEW COVID-19 CASES CONTINUE to be reported weekly. No one yet understands whether SARS-CoV-2 may disappear at some future date (as did the 1918 influenza pandemic and SARS outbreak in 2003) or whether SARS-CoV-2 will become endemic and stay with us for years….
New Lab, Pathology Trends at Executive War College 2021
CEO SUMMARY: Hundreds of lab leaders traveled to San Antonio last week for the 27th annual Executive War College on Laboratory and Pathology Management. After almost two years of virtual conference and meetings using Zoom, attendees were ready to gather for a live event, complete with speakers,…
CLIA Lab Director Testimony Shows Risks to Pathologists
CEO SUMMARY: Elizabeth Holmes’ criminal trial is a case study for clinical lab directors in how not to run a medical lab, according to an attorney with 30 years of advising labs on CLIA-enforcement issues. During the trial, federal prosecutors cited the Clinical Laboratory Improve…
Post-COVID: Repurposing Excess PCR Instruments
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…
New Class of IVD Firms Wants to Serve POCT in Near-Patient Settings
CEO SUMMARY: Our second installment in this series describes an emerging new clas…
Lab Briefs
DOJ Obtains $140 Mil. Settlement in Drug Testing Case Last Friday, the U.S. Department of Justice (DOJ) announced a settlement totaling $136,025,077 with multiple defendants accused of using illegal inducements to encourage physicians to re…
2020 Rankings of the World’s Largest IVD Corporations
IN VITRO DIAGNOSTICS (IVD) MANUFACTURING continues to be dominated by a handful of companies, all of which sell their products worldwide. As the rankings below demonstrate, for 2020, just 11 companies accounted for 82.7% of international IVD sales. The …
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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