TAG:
ivd/lab informatics
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 …
Strategies to Succeed with Laboratory Outreach Programs
In recent years Labcorp and Quest Diagnostics went on buying sprees, acquiring laboratory outreach businesses from major health systems. They argue that they can run these operations more efficiently, while the sellers get much-needed cash infusions. (See …
Quest, Labcorp Tout Their Alzheimer’s Tests and Use of AI
Executives at Quest Diagnostics and Labcorp cheered strong revenue growth in the third quarter. Both companies noted excellent recent launches of Alzheimer’s disease tests. In addition, both companies reported they are leaning heavily into artificial intelligen…
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…
After Regaining Outreach, Lab Grows it by $10M
CEO SUMMARY: In this case study, Kootenai Health in Idaho explains how taking back lab outreach services from a commercial lab company can improve physician satisfaction, enhance patient care, and increase revenue. Although the transition was bumpy, within two years of bri…
2025 Ranking of the World’s Top 13 IVD Corporations
BASED ON PUBLICLY-REPORTED 2024 DIAGNOSTICS-RELATED REVENUE, four in vitro diagnostics (IVD) companies continue to dominate the global market, as they have for the last two years: Thermo Fisher Scientific, Roche, Danaher, and Abbott Laboratories. The top 13 companies …
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…
AI Hype in Labs: 6 Tips to Sniff Out the BS
CEO SUMMARY: In the final entry of our artificial intelligence series, the co-founders of Sample Healthcare discuss how clinical labs can evaluate AI vendors effectively, with an emphasis on assessing technical credentials and quick proofs of concept. Armed with the right …
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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