TAG:
FDA
Congress Returns to CLIA Reform with Proposed LDT Framework
CEO SUMMARY: 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. Not only does the Enhancing CLIA…
For IVD Companies, Tariff Refunds May Be a Long Haul
Following the US Supreme Court’s decision declaring certain tariffs illegal, the diagnostics industry has entered a murky period regarding potential refunds. For in vitro diagnostics (IVD) manufacturers who paid these tariffs under policies f…
Major Players Back Robotic Phlebotomy with $70M
While total laboratory automation has permanently altered the analytical phase of clinical laboratory work, the front-end collection process has remained a stubbornly manual, labor-intensive bottleneck. However, that may be about to change, based on early signs….
February 9, 2026, Intelligence: Late-Breaking Lab News
Texas Attorney General Ken Paxton filed a lawsuit against Epic Systems, intensifying scrutiny of how pediatric medical records are controlled and the broader power of dominant electronic health record (EHR) vendors. The suit alleges Epic unlawfully monopolizes the EHR…
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 …
Pathologists Take Images to the Cloud
CEO SUMMARY: Scaled-up operations, streamlined logistics, and potential cybersecurity benefits all present a valid argument for pathology practices to move their data to the cloud. Digital pathology in particular stands to gain from a cloud-based setup that allows remote v…
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 …
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…
CURRENT ISSUE
Volume XXXIII, No. 9 – July, 2026
Newsmaker Interview with Revvity’s Yves Dubaquie > How Specialty Diagnostic Tests Connect with Lab Customers: In this exclusive Q&A, Revvity’s Yves Dubaquie provides details about the in vitro diagnostics company’s priorities, including developing specialty tests and reviewing its business in China. Dubaquie also explains why clinical laboratories may need to consider hiring more technology-savvy workers in the future as the complexity of instruments grows.
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