In Vitro Diagnostic Use Articles & Analysis
13 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 ...
Additionally, the Accula System has received Emergency Use Authorization (EUA) from the FDA for SARS-CoV-2 in vitro diagnostic testing and is now available for use in patient care settings, providing results within 30 minutes, with higher accuracy than other rapid tests on the market. "Mesa Biotech's innovative platform will ...
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. ...
The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the U.S. ...
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 ...
Abionic SA, the developer of proprietary disruptive nanotechnology based rapid diagnostic solutions, and Genentech, a member of the Roche Group, announced today a strategic agreement to develop and provide an In Vitro Diagnostic (IVD) Asthma Test Panel using Abionic’s POC abioSCOPE® platform in the United States. ...
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. ...
BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, is rapidly implementing plans to expand its medical device Notified Body scope to include in vitro diagnostic (IVD) devices. BSI has appointed Sue Spencer, an IVD industry veteran, to lead what looks to be an early 2010 expansion. ...