Reliable Business Intelligence News About Clinical Laboratories, Pathology Groups, & Laboratory
Diagnostics Since 1995
The most complete archive of clinical and pathology lab industry news available, including issues from 1997 to the present.
Congress Returns to CLIA Reform with Proposed LDT Framework, and the Newly Filed Enhancing CLIA Act seeks to modernize clinical laboratory regulations. A newly introduced federal bill could signal the next chapter in the long-running debate over how laboratory developed tests (LDTs) should be regulated in the United States.
Momentum is building on Capitol Hill to pass the RESULTS Act, which would stave off drastic 15% reimbursement cuts under PAMA. Advocates seek lobbying help from clinical labs and anatomic pathology practices. Also, The Dark Report examines Roche’s deal to acquire PathAI.
Speakers at the 2026 Executive War College have re-imagined the diagnostic laboratory’s role from back-office utility to a primary driver of system-wide strategy and clinical excellence. Also, it is apparent that direct-to-consumer lab testing is booming.
Another integrated delivery network mega-deal has been proposed, with California’s Sutter Health planning a merger with Minnesota’s Allina Health. Also, refunds for President Trump’s illegal tariffs may be forthcoming for IVD importers, but it will be a struggle.
A federal court ruling has established a safe harbor for clinical labs when they run tests ordered by physicians. Lab leaders should examine this briefing for pitfalls. Also, it turns out that providers may be ordering inappropriate vitamin D tests, according to one expert.
The Dark Report highlights the six themes that will carry the 2026 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management,, including finance issues and AI. Also, we show how RCM automation helped one lab conquer billing headaches and increase revenue.
Congress has once again delayed cuts to test reimbursement rates under PAMA, this time until Jan. 1, 2027. Laboratory professionals are urged to lobby Congress to pass the RESULTS act to solve the PAMA cuts problem permanently. Also, patient-driven testing is spurring new opportunities.
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.
The Dark Report reviews its top 10 stories from 2025, from the vacating of the FDA’s LDT rule to the merger of Waters and Becton Dickinson’s biosciences and diagnostics units. Also, a lab outlines its solution to a shortage of histotechnologists, and another story shows how pathologists can become patients’ partners.
Laboratory professionals are urged to make their voices heard in Congress as the end of a brief reprieve to PAMA cuts comes on January 30, 2026. Congress is said to be inclined to address reformation of PAMA now. Also, pathologists are slowly switching to cloud storage for their digital slides.
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Volume XXXIII, No. 8 – June, 2026
Congress Returns to CLIA Reform with Proposed LDT Framework, and the Newly Filed Enhancing CLIA Act seeks to modernize clinical laboratory regulations. A newly introduced federal bill could signal the next chapter in the long-running debate over how laboratory developed tests (LDTs) should be regulated in the United States.
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