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FDA Reviews Oncology Companion Diagnostics
Legal experts say a proposal would streamline approvals and boost laboratory innovation
CEO SUMMARY: Regulatory attorneys indicate that the FDA’s move to reclassify oncology companion diagnostics to Class II medical devices could speed approvals and reduce costs for submissions. From a business perspective, the proposal could allow clinical laboratories to ...
Cuts to Rural Labs Boost RESULTS Act Support
Lawmakers worry about how upcoming rate decreases will hurt smaller clinical laboratories
CEO SUMMARY: Two related legislative concerns should have the sharp attention of clinical laboratory leaders, particularly those in rural areas. On one end, PAMA cuts are scheduled to hit on Jan. 31 short of another reprieve from Congress. Meanwhile, lawmakers at a recent ...
Bringing Lab Testing to Hybrid Care Locations
Reference lab TriCore implements diagnostic testing at combined urgent/emergency care sites
CEO SUMMARY: Clinical laboratory testing plays an important role in individual urgent care and emergency sites, but when such services are offered under one roof, planning for lab tests, related equipment, and CLIA provisions becomes more complicated. TriCore shares its ex...
Translating Genomic Testing to the Clinic
How to turn scientific research into a viable busi- ness plan for real-world diagnostic applications
CEO SUMMARY: An entrepreneur in the liquid biopsy sector outlines a series of questions to answer if a diagnostic innovation is to ever succeed in the commercial marketplace. Scientists and businesspeople will want to ask about a potential product’s significance, uniquen...
Where to Proceed Cautiously with AI in the Clinical Lab
Expert discusses guardrails that include explicit human intervention when AI presents insights
Not since the smartphone debuted has a technology created as much hype as artificial intelligence (AI). Clearly mobile phones proved to be a cornerstone of business, and AI may eventually find similar footing. But as the AI revolution unfolds, ...
AI Reshapes Job Market: New Priorities for Clinical Labs
LinkedIn data indicates healthcare reimbursement specialist is a top-growing US role
Artificial intelligence (AI) is no longer a future consideration in the job market. Instead, it is actively reshaping how professionals find work, how roles are defined, and which skills employers value most. According to recent LinkedIn resear...
Crucial Themes Shape 2026 Executive War College
With 2026 now upon us, our attention here at The Dark Report starts to look towards April and the 31st Annual...
CURRENT ISSUE
Volume XXXIII, No. 1 – January 19, 2026
The Dark Report looks at the FDA’s move to reclassify Oncology companion diagnostics as Class II medical devices and considers how labs can benefit. Also, observers are concerned about the effect of PAMA cuts on rural clinical laboratories.
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