TAG:
pcr assay
Most IVD Firms Increase Q3 2023 Base Business Revenue
Most in vitro diagnostics (IVD) companies reported increases in base business during the third quarter (Q3) 2023. The numbers, in the single digits, softened the blow from the continuing drop-off in COVID-19 test sales. Manufacturers of tests and laboratory instruments are launching ne…
UnitedHealth’s Lab Test Registry Implementation Delayed Again
ANOTHER DELAY WAS ANNOUNCED FOR IMPLEMENTATION of UnitedHealthcare’s Laboratory Test Registry Protocol, which requires clinical laboratories to register each of their tests with the health insurer. This latest delay likely is the result of operational issues on behalf of the managed care com…
Newer, Smaller Analyzers Will Bring Big Data to Labs
CEO SUMMARY: Clinical laboratories of all sizes are poised to become the source of much of a hospital or health system’s “big data.” At many academic center labs, greater use of genetic and molecular testing requires that more space and more staff be devoted to data management. A…
Hospital Labs Have New Options for Molecular Dx
CEO SUMMARY: Laboratories that offer molecular assays continue to see strong growth in four areas: oncology, hematopathology, infectious diseases, and personalized medicine. Further, a new generation of molecular testing systems and analyzers is coming to market which will make it easier …
Focus Technologies Offers SARS Test to Clinicians
EARLIER THIS MONTH, Focus Technologies reference laboratories of Cypress, California announced the development of a “first-generation, real-time PCR test” designed to detect the presence of the coronavirus associated with severe acute respiratory syndrome (SARS). “Focus devel…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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