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In Vitro Diagnostic Use Articles & Analysis
9 news found
Founded in 2009 and headquartered in Boulder, Colorado, LightDeck has developed a scalable and innovative platform for rapid and accurate point of care diagnostics. LightDeck’s 80-member team includes industry veterans, engineers, and scientists, with deep technical expertise in assay development, manufacturing, and software development, who have collaborated with ...
Results of this prospective trial confirm the performance of previously published European and US retrospective validation studies in real world practice. On 22 April 2021, Biocartis and SkylineDx announced a partnership aimed at developing SkylineDx’ novel proprietary test, the Merlin Test, on Biocartis’ rapid and easy-to-use molecular ...
About FoundationOne®CDx FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational ...
About FoundationOne Liquid CDx FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from ...
Thermo Fisher Scientific today announced the completion of the U.S. Food and Drug Administration (FDA) listing for the Applied Biosystems QuantStudio 5 Dx Real-Time PCR System. The innovative product enables clinical laboratories and assay developers to meet testing demands and enhance their molecular diagnostics workflows. Clinical diagnostic and hospital laboratories across the United States ...
Food & Drug Administration (FDA) for in vitro diagnostic use. Test results can aid specialists and other healthcare providers as they diagnose a patient's sensitization to the alpha-Gal carbohydrate found in mammalian (red) meat and assess his or her risk for an anaphylactic reaction. ...
Food & Drug Administration (FDA) for in vitro diagnostic use. Results from these component tests can act as a diagnostic aid to help specialists and other healthcare providers discriminate between true sensitization and cross reactivity, identify culprit insect(s) in patients with inconclusive patient history, and may help ...
The portfolio enables clinical diagnostic laboratories to leverage a comprehensive platform for developing sensitive and reliable laboratory developed tests (LDTs). ...
View the full release here: http://www.businesswire.com/news/home/20160105005342/en/ "Waters pioneered the use of LC-MS as medical devices over a decade ago," said Jeff Mazzeo, Senior Director, Health Sciences for Waters Division. ...