Siemens Healthineers Launches FDA-Cleared D-Dimer Blood Test
Siemens Healthineers has launched the FDA-cleared Innovance D-Dimer 2.0 assay, designed for rapid exclusion of DVT and PE in outpatients and optimized for STAT laboratory testing.
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CMS Releases Preliminary 2027 CLFS Rates as CAP Calls for Payment Reform
CMS has released preliminary 2027 CLFS rates, with data showing weighted median payment cuts for over 1,100 test codes; annual reductions are capped at 15% from 2027 to 2029 under current policy.
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Every week, we dig into the biggest shifts, breakthroughs, and tech transforming clinical diagnostics. Straightforward, insightful, and always relevant.Critical Resources
Diagnostic Innovations
FDA Clears Qiagen Gram-Negative Bloodstream Infection Panel
The FDA has cleared Qiagen’s QIAstat-Dx BCID GN Plus AMR Panel, enabling U.S. labs to detect 13 gram-negative bacterial pathogens and 18 resistance markers in about one hour on the QIAstat-Dx system.
Equipment & Supply Spotlight
OGT Unveils SureSeq NGS Automation Compatible with Hamilton NGS STAR Line
OGT has launched automation-enabled SureSeq NGS workflows compatible with the Hamilton NGS STAR Line, aiming to reduce manual steps and increase throughput for clinical research labs managing higher sample volumes.
News, Know-How & Standards
Disease Detection & Understanding
Revvity Launches IVDR-Certified Triplex Autoantibody Assay for Early Type 1 Diabetes Screening
Revvity has introduced the CE-IVDR-certified GSP T1D 3plex kit, a multiplex dried blood spot assay for early type 1 diabetes screening in children, designed to support population-level programs.
