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Tag Archives: Instrumentation Laboratory

Digital path’s star rises from the mists

October 2023—In living up to its promise as a new technology that will revolutionize clinical care through greater ease, speed, and accuracy of diagnosis, digital pathology has been sluggish. While many analysts, starting at least two decades ago, forecasted that digital pathology would elbow aside glass slides for good, that milestone is still far out of reach. As health economist and chief executive officer of the New York City-based digital pathology company Paige, Andy Moye, PhD, puts it bluntly: “In probably 90 to 95 percent of the cases in the U.S., a pathologist still makes the diagnosis of cancer the way they did it back in 1910: by looking at a glass slide under a microscope.” Mark Lloyd, PhD, vice president of pathology for Fujifilm, says he wouldn’t be surprised to hear that perhaps only five percent to 10 percent of hospitals have moved beyond using only glass slides to offer pathologists digital pathology capability. In fact, Dr. Lloyd thinks those percentages are overstated. What is the market share for the clinical use of digital pathology?

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NGS in more labs? IFCC group aims to ease the way

May 2021—When it comes to next-generation sequencing, don’t count out community hospital labs, especially as black-box solutions come on the market. That’s the hope of members of an International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group that aims to help clinical labs develop in-house NGS programs. Large-scale genomic testing won’t be necessary or practical at the community hospital level. But hospital-based genomic testing programs should set out to meet the NCCN guideline targets and provide testing for which a wide range of sample input and quality can be accepted, says Robyn Sussman, PhD, a member of the IFCC working group and molecular development assistant director, Penn Precision and Computational Diagnostics, University of Pennsylvania Perelman School of Medicine.

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Chemiluminescent assay for HIT, 1/18

January 2018—Instrumentation Laboratory announced FDA 510(k) clearance of the HemosIL AcuStar HIT-IgG(PF4-H) Assay and HemosIL AcuStar HIT Controls. The assay is an on-demand, fully automated chemiluminescent reagent for use on hemostasis testing systems for the qualitative detection of platelet factor 4 (PF4)-heparin complex IgG antibodies associated with heparin-induced thrombocytopenia.

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IL launches GemWeb Plus 500, 9/17

September 2017—Instrumentation Laboratory launched its customized connectivity solution, GemWeb Plus 500. From its dashboard, GemWeb Plus 500 offers complete control of Gem Premier critical care testing systems, including Gem Premier 5000 with Intelligent Quality Management 2, as well as connectivity to non-IL-manufactured devices at the point of care. GemWeb Plus 500 is accessible from tablet devices, PCs, and any networked analyzer.

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Hemostasis testing systems, 1/16

January 2016—Instrumentation Laboratory announced the 510(k) clearance of its ACL TOP Family 50 Series Hemostasis Testing Systems. Designed for mid- to high-volume clinical laboratories, including those using lab automation tracks, the ACL TOP Family 50 Series systems, comprising five models, offer preanalytical quality assurance, risk-management, and laboratory accreditation benefits.

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