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Volume XXIX, No. 8 - June 6, 2022

Passage of FDA LDT Regulation Inches Closer in the Senate

TDR Insider / By

This is an excerpt of a 819-word article in the June 6, 2022 issue of  THE DARK REPORT. The full article is available to members of The Dark Intelligence Group. CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are …

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Halfway Through 2022, More Changes Come at Labs

Commentary and Opinion by R. Lewis Dark / By

APPROACHING THE MIDWAY MARK OF 2022, some clinical laboratory directors and pathologists might feel like they’ve already experienced enough changes to last the whole year.  For example, since the start of 2022, we’ve seen SARS-CoV-2 testing surges come and go, as well as changes to the No Surprises Act’s out-of-network billing procedures. At the same …

Halfway Through 2022, More Changes Come at Labs Read More »

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Atrium, Advocate Aurora Merge into $27b System

Clinical Laboratory Trends / By

CEO SUMMARY: Integrated delivery networks continue to consolidate in the U.S., with the latest example being the merger of Atrium Health and Advocate Aurora Health. The deal forms a 67-hospital system across two distinct geographic areas in the Southeast and upper Midwest. IDN mergers raise the value of longitudinal test records for patients, with IDNs …

Atrium, Advocate Aurora Merge into $27b System Read More »

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Passage of FDA Regulation of LDTs Inches Closer in the Senate

Lab Risk & Compliance, Laboratory Compliance / By

CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. FDA Would Approve LDTs The bipartisan Verifying Accurate Leading-Edge IVCT Development (VALID) …

Passage of FDA Regulation of LDTs Inches Closer in the Senate Read More »

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Amazon to Close Employee COVID-19 Testing Lab in Ky.

Laboratory Management / By

IN A MOVE THAT MAY SURPRISE SOME OBSERVERS, Amazon announced it will close its COVID-19 employee testing laboratory in Hebron, Ky., which is just across the Ohio River from Cincinnati.  This is the second large COVID-19 clinical laboratory to publicly announce it will cease operations instead of transitioning to conduct other non-COVID testing for either …

Amazon to Close Employee COVID-19 Testing Lab in Ky. Read More »

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DOJ Charges Execs over Alleged Lab Kickbacks to Obtain Restitution

Lab Risk & Compliance, Laboratory Billing, Laboratory Compliance / By

CEO SUMMARY: Multiple executives and sales representatives at True Health Diagnostics and Boston Heart Diagnostics have been named as defendants in a civil suit filed by the U.S. Department of Justice. The complaint centers on alleged kickbacks in return for clinical laboratory test referrals. The companies and employees involved have been associated with allegations, a …

DOJ Charges Execs over Alleged Lab Kickbacks to Obtain Restitution Read More »

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Lab Vendors Adjusting to Changing Sales Practices

In Vitro Diagnostics / By

CEO SUMMARY: Important changes are happening in how lab managers research and buy new lab analyzers, automation, test kits, and consumables. Today, a large proportion of a lab buyer’s research and interaction involving new products is done digitally. This includes virtual sales calls, say two IVD lab marketing experts.  WHEN IT COMES TO MARKETING AND …

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June 6, 2022 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By

Monkeypox is the latest disease showing up in the United States. That means hospital laboratories will want to be ready to diagnose monkeypox cases that show up in their emergency departments. An official from the Centers for Disease Control and Prevention (CDC) says it is exploring the possibility of expanding capacity for monkeypox testing if …

June 6, 2022 Intelligence: Late-Breaking Lab News Read More »

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