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Volume XXXIII, No. 1 - January 19, 2026

Translating Genomic Testing to the Clinic

Clinical Laboratory /

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, uniqueness, and soundness. Those questions will help determine a product’s true value to its target […]

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Where to Proceed Cautiously with AI in the Clinical Lab

Laboratory Management /

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, clinical laboratories should approach artificial intelligence deliberately. Labs must establish clear guardrails that prioritize patient safety,

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AI Reshapes Job Market: New Priorities for Clinical Labs

Laboratory Management /

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 research published on Jan. 7, 56% of professionals plan to job-hunt this year, yet 76% say they feel unprepared

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January 19, 2026, Intelligence: Late-Breaking Lab News

Late Breaking Lab News /

Entrepreneur Mark Cuban is calling for financial penalties to curb what he describes as systemic overbilling across the US healthcare system, a proposal that could significantly raise the stakes for insurers, hospitals, and clinical laboratories. In a provocative Dec. 24 post on X, Cuban argued that routine overbilling, improper claim denials, and misleading patient cost

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FDA May Reclassify Oncology Companion Diagnostics to Class II Devices

TDR Insider /

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 expand their testing options, bring more tests in house, and attract new investment. The public comment period for the

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Crucial Themes Shape 2026 Executive War College

Commentary and Opinion by R. Lewis Dark /

With 2026 now upon us, our attention here at The Dark Report starts to look towards April and the 31st Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management. The conference’s organizers and external advisors are hard at work shaping an agenda that brings together the most relevant macro trends, technological advancements, and

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FDA Reviews Oncology Companion Diagnostics

Laboratory Compliance /

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 expand their testing options, bring more tests in house, and attract new investment. The public comment period

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Cuts to Rural Labs Boost RESULTS Act Support

Laboratory Billing /

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 hearing sought further information about the RESULTS Act, which would reform the

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Bringing Lab Testing to Hybrid Care Locations

Clinical Laboratory /

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 experience establishing laboratories in these hybrid settings, including lessons learned along the way and benefits

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