TAG:
FDA
FDA Hosts Webinar to Explain Key Issues with Final LDT Rule
ON APRIL 29. THE US FOOD AND DRUG ADMINISTRATION (FDA) announc…
Labcorp, Quest Issue Q1 Earnings, Offer Comments on FDA’s LDT Rule
BOTH LABCORP, BURLINGTON, N.C., AND QUEST DIAGNOSTICS, SECAUCU…
New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks
CEO SUMMARY: There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 ho…
Artificial Intelligence and Executive War College
By the time you read this our 29th annual Executive W…
Congressional Subcommittee Hears Testimony on FDA LDT Rule
DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…
Lab Market Fragmenting, Creating New Opportunities
CEO SUMMARY: Even as consolidation continues in the ownership of hospitals, health systems, office-based physicians, and clinical laboratories, there is a powerful trend of fragmentation quietly transforming the way providers—including clinical labs and pathology groups—serve patient…
FDA Issues Memo to Reclassify Many High Risk IVD Assays
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings
DURING RECENT EARNINGS CALLS WITH FINANCIAL ANALYSTS AND INVESTORS, both Labcorp and Quest Diagnostics discussed their fourth quarter (Q4) and full year 2023 financial results. Each reported some stability in the market for clinical laboratory testing services, reflected in the numbe…
Labs Should Prepare for Arrival of ‘Perfect Storm’
CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…
Read the Tea Leaves… FDA Will Require LDT Review
PROPOSED FEDERAL REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) IS CURRENTLY THE HOT-BUTT…
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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