TAG:
ldt
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…
CMS Issues AI Guidance for Medicare Advantage
CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal governme…
Read the Tea Leaves… FDA Will Require LDT Review
PROPOSED FEDERAL REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) IS CURRENTLY THE HOT-BUTT…
Who’s For and Against FDA Draft LDT Rule?
CEO SUMMARY: One analysis determined that 43.2% of the public comments were in support of the proposed LDT rule and 55.2% were in opposition to the rule. More telling, however, is that of the 2,900 comments in support, only 56 were not form letters! In contrast, about 1,300 individual com…
FDA & CMS Issue Letter, Agree on LDT Oversight
CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…
FDA Has a Ticking Time Bomb with LDT Rule
PROPOSED REGULATION OF LABORATORY DEVELOPED TESTS (LDTs)…
2024: Year of Decision for FDA Regulation of LDTs
FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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