TAG:
next generation sequencing
Boosting Path Revenue with POC Services
CEO SUMMARY: The concept sounds simple—bring mobile point-of-care pathology services to physician offices and ambulatory surgical centers via specially equipped vehicles. Doctors Pathology Services explains some of the road bumps it hit along the way while also uncoverin…
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 …
Insights on Innovative Tech and Running a Clinical Lab in 2026
CEO SUMMARY: William Morice II, MD, PhD, the CEO at Mayo Clinic Laboratories, discusses technology that intrigues him and the important steps clinical laboratory leaders can take to better steer revenue opportunities as they head into the new year. Morice also comments on …
Reforms in China Affect IVD Companies’ Q3 2025 Earnings
Most of the in vitro diagnostics (IVD) manufacturers that serve clinical laboratories worldwide reported facing financial “headwinds” in the China IVD market that affected their third-quarter performance. This was due to policy changes in the country…
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…
Despite Trade Tariffs, IVD Firms Report Upbeat Earnings
LEADING IN VITRO DIAGNOSTICS (IVD) COMPANIES RECENTLY REPORTED POSITIVE QUARTERLY FINANCIALS despite swirling concerns about trade tariffs and cuts to US federal research grants. It’s not yet clear what the long-term effect of tariffs’ will be on IVD manu…
Clinical Labs Battle Complex Claims Denials
CEO SUMMARY: While the number of denials is not going up, the reasons that private payers deny claims are becoming more complex and time-consuming to appeal. After reviewing noteworthy trends among payers, learn a three-level approach to appeals that may lead to greater su…
AMP Reports Provide Crucial Insights for Hiring Managers
IN AN EXCLUSIVE INTERVIEW WITH THE DART REPORT, Somak Roy, MD, chair of AMP’s Clinical Bioinformatician Body of Knowledge Steering Committee, shared best practices that hiring managers at clinical molecular diagnostic laboratories can use to ascertain which candidates could b…
Labcorp and Quest Discuss Outreach Acquisition Potential
GIVEN THE POTENTIAL UPSIDE OF HUNDREDS OF MILLIONS OF DOLLARS IN ADDED REVENUES, both Labcorp and Quest Diagnostics remain on the prowl to acquire more hospital laboratory outreach …
IVD Companies Launch New Assays, Analyzers, Automation
Steep declines in SARS-CoV-2 test revenue were reported by the top in vitro diagnostics (IVD) companies in Q2 2023 earnings compared to a year earli…
CURRENT ISSUE
Volume XXXIII, No. 3 – March 2, 2026
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.
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