Scott Wallask
Articles by Scott Wallask
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…
After SALSA Hits a Wall, New RESULTS Act Steps In
Upon reading the briefing in the last issue about the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, someof our members may have wondered,“What happened to SALSA?” SALSA, more formally known as the…
Lumea’s Digital Pathology Success Lands It on Inc. 5000
Digital pathology company Lumea was perhaps the most notable entry from the clinical laboratory world to make it onto the Inc. 5000 list of the fastest growing private companies in America in 2025. Lumea placed mid-pack at No. 2,468 …
National Lab Company Briefs
Quest, Labcorp Push Alzheimer’s Test Quest Diagnostics and Labcorp are now offering Fujirebio’s Lumipulse test, the first Food and Drug Administration-cleared blood-based assay for con…
Labs Directly Attack Upcoming PAMA Cuts
CEO SUMMARY: The clinical laboratory industry once again finds itself advocating on Capitol Hill for proposed legislation to deal with an old problem: test reimbursement rate cuts under PAMA. While Congress has delayed scheduled rate cuts for the last several years, PAMA c…
Court: Percentage-Based Comp Is Not Illegal in Itself
OUR MEMBERS LEARNED IN THE PRIOR ISSUE ABOUT AN IMPORTANT COURT RULING that interpreted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), a law that has long been maligned by clinical laboratories for its murkiness. The Dark Report has since talked in…
Former Payer CEO Posts Sharp Comments on LinkedIn
FORMER CEO OF PUBLICLY-TRADED INSURANCE COMPANY MOLINA HEALTHCARE, J. Mario Molina, MD, took to LinkedIn in July offering a sobering perspective on the current state of the private payer industry. Drawing on his 14 years at the helm, Molina remarked, “What’s happening right now does…
My Green Lab Prepares Full-Scale Entry into Diagnostics
AGAINST THE BACKDROP OF REDUCED SUSTAINABILITY INITIATIVES IN THE CORPORATE AND POLITICAL WORLDS, environmental stewardship remained a topic of discussion at the Association for Diagnostics and Laboratory Medicine’s (ADLM) 2025 conference. Among the more interesting announcements wa…
August 25, 2025, Intelligence: Late-Breaking Lab News
As we first reported in Dark Daily earlier this month, several states have taken initiative to regulate how artificial intelligence (AI) applies to clinical laboratory services. For example, a California law that went into effect earlier this year impacts providers who use gene…
CURRENT ISSUE
Volume XXXIII, No. 2 – February 9, 2026
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.
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