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AMP criticizes FDA action on lab-developed Zika test

The Association for Molecular Pathology says it “is very concerned and disappointed” about the FDA’s letter to the Texas developers of a molecular test that can detect Zika virus-specific RNA sequences in a large metropolitan area. “Given the ongoing outbreak of the infection and risk of infection in the Houston area, these types of tests...
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Clampdowns on out-of-network billing climb

To the average reader, “out-of-network billing” might seem like a technical concept that should mainly concern hyperaware insurance wonks. Media outlets from NBC News to Time to the Huffington Post have found that phrases like “surprise medical bill,” “angry patients,” and sometimes “sticker shock” in recent stories are much more likely to grab attention. But...
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Molecular staph blood culture panel lands 510(k)

Great Basin Scientific has received FDA clearance for its Staph ID/R Blood Culture Panel. The panel is a sample-to-result, automated, DNA multiplex assay for simultaneous identification of Staphylococcus aureus and Staphylococcus species directly from positive blood cultures in about two hours. The panel identifies coagulase-negative staphylococci such as S. epidermis that are the part of...
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Rapid sepsis test shortens hospital stays

A study published in the Archives of Pathology & Laboratory Medicine demonstrates the clinical and economic impact of implementing rapid sepsis diagnostic testing with Nanosphere‘s FDA-cleared Verigene Gram-Positive Blood Culture Test (BC-GP) in a pediatric patient population. The outcomes study was conducted at Children’s Hospital Los Angeles. “Our study is the first to assess the clinical...
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Most DTC genetic results not shared with doctors

Direct-to-consumer genetic testing may create unrealistic expectations for patients and a conundrum for physicians who largely feel unprepared to discuss test results, says a recent study. Using data from the Impact of Personal Genomics Study, a large, longitudinal study of actual users of 23andMe and Pathway Genomics DTC genetic tests, researchers described the characteristics and...
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CE for BD blood separation technology

Becton, Dickinson has obtained the CE mark in for a next-generation blood separation technology that is designed to enhance sample quality, improve laboratory efficiency, and reduce laboratory turnaround time. The BD Vacutainer Barricor tube is a single-use, plastic evacuated tube used to collect, separate, transport, and process venous blood specimens to obtain high-quality plasma for...
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Guideline tackles bone marrow specimen reporting

The CAP‘s Pathology and Laboratory Quality Center has released an evidence-based guideline that aims to tackle the complexities of reporting findings from bone marrow specimens. Published in an early online release of the Archives of Pathology & Laboratory Medicine, “Bone Marrow Synoptic Reporting for Hematologic Neoplasms” provides evidence-based recommendations that help pathologists and laboratories consistently,...
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Sysmex touts advanced clinical parameters

Sysmex America has launched an educational section on its website that aims to provide information to laboratory professionals about the company’s Advanced Clinical Parameters, which are tests that provide additional information about the state of blood cells. ACPs expand the complete blood count laboratory test and aid in the detection of several hematological conditions. “The...
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