TAG:
laboratory-developed test
FDA Reviews Oncology Companion Diagnostics
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 …
Top Stories in 2025 Played Out in Courts, Capitol Hill
CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to incr…
In 2026, Challenges Can Be Business Opportunities
Looking over The Dark Report’s annual rundown of the most significant clinical laboratory and pathology stories of the past year, the world “tumult” comes to mind. At points during the past year the tumult leaned in the favor of labs, such as a federal …
FDA Has Future Avenues to LDT Oversight
CEO SUMMARY: Even though a federal court vacated the FDA’s final rule for laboratory developed tests, experts warn that the agency may still be able to regulate some LDTs via its authority over diagnostic software. An attorney notes that software’s central role in mode…
Could AI Oversight in Labs Fall Under a CLIA Model?
CEO SUMMARY: Clinical AI is advancing faster than regulation, creating risk for medical labs. An expert discusses using CLIA to oversee development and ensure safety, performance, and accountability while complementing FDA oversight. Lab leaders face regulatory uncertainty…
At ADLM 2025, Spotlight Shines on Relationships
CEO SUMMARY: At the ADLM conference, a new industry survey about the dynamic relationship between medical laboratories, physicians, and patients presented a strong argument for labs taking the lead in communicating and being more accessible to their colleagues. A troubleso…
JAMA Authors Warn LDT Legal Defeat Brings Risk for Labs
CLINICAL LABORATORY AND ANATOMIC PATHOLOGY LEADERS WILL WANT TO NOTE will a recent JAMA Health Forum article that strikes a cautionary tone about the future of laboratory developed test (LDT) regulation. The piece argued that the recent federal court decision…
For AI Regulation, Look to Data Laws, FDA Action
CEO SUMMARY: AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics. Few court cases exist yet that interpret AI use within clinical settings, but labs must watch how HIPAA and state laws wield influence. Vendor soft…
Lab Stakeholders Discuss PAMA Reform
CEO SUMMARY: Medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Although labs have received PAMA reprieves from Congress over the last few years, laboratory associations argue that Congress needs to vote on long-term reforms rather than …
Lab Industry Fallout from CLIAC Termination
CEO SUMMARY: Some diagnostic lab leaders and anatomic pathology practice owners may not immediately think that the elimination of a federal advisory panel should be on their radar. But the demise of the Clinical Laboratory Improvement Advisory Committee may cost labs by de…
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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