FDA Approves FoundationOne CDx as Companion Diagnostic to Detect NTRK Fusions Across All Solid Tumors
The tissue-based comprehensive genomic profiling test is currently approved as a companion diagnostic for more than 20 targeted therapies.
Category: Molecular Diagnostics
Molecular Diagnostics
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Molecular Diagnostics
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GenMark’s ePlex Respiratory Pathogen Panel 2 Receives FDA EUA
The RP2 Panel provides results in less than 2 hours for more than 20 viruses and bacteria that cause common respiratory infections with similar symptoms, including covid-19, flu, bronchitis and the common cold.
Molecular Diagnostics
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Aperiomics Brings Pathogen Testing to Integrative Healthcare Field
With a single test of any biological sample, Aperiomics seeks to accurately identify all microbes present—including pathogens—whether bacteria, fungus, parasite, or virus.
FDA Updates Covid-19 Reference Panel Comparative Data
The reference panel allows for a more precise comparison of the analytical performance of different molecular IVD assays to detect covid-19.
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Qiagen Fully Acquires NeuMoDx Molecular
The acquisition rounds out Qiagen’s portfolio of automated molecular testing solutions based on the proven PCR technology.
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September 2020 Tech Guide: Molecular Diagnostics
The September 2020 Tech Guide features molecular diagnostic system and panels from BD, DiaSorin Molecular, Luminex, Qiagen, Randox, Streck, and more.
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FDA Publishes Comparative Performance Data for Covid-19 Molecular Diagnostics
The tables show the Limit of Detection of more than 55 authorized molecular diagnostic covid-19 tests against a standardized sample panel provided by the FDA.
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Large Prospective Lung Cancer Study to Be Presented at ESMO
Idylla reduced EGFR mutation testing turnaround time by more than a week versus reference methods for patients with NSCLC.
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MiniPCR Bio Launches Gelato Electrophoresis System for Fast DNA Analysis
Gelato combines gel electrophoresis and transillumination technology for simultaneous nucleic acid separation and visualization in a single, compact system.
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PCR Biosystems Launches RiboShield RNase Inhibitor
Already an important component of several PCR Biosystems kits, RiboShield RNase Inhibitor is, for the first time, available as a standalone product.
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Sysmex Inostics’ Liquid Biopsy Testing Aids Pancreatic Cancer Management
cfDNA-based liquid biopsy analysis of KRAS mutations using OncoBEAM technology can assist in the prognosis determination and management of PDAC patients.
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RNA Extraction for Covid-19 Diagnostic Testing
The Chromatrap Homogeniser Spin Column has been adapted to routinely improve yield and quality of covid-19 viral RNA from nasal and throat swab samples.
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Zymo Research Granted CE IVD Mark for Quick SARS-CoV-2 rRT-PCR Kit
This kit features a limit of detection as low as 15 GEC per reaction and includes ready-to-use reaction mixtures to reduce hands-on time.
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FDA Approves Roche HIV-1/HIV-2 Qualitative Test on Cobas Systems
The test provides healthcare professionals with a single result to confirm HIV diagnosis and to differentiate HIV-1 and HIV-2.
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T2 Biosystems Gets FDA EUA for Covid-19 Molecular Diagnostic
The T2SARS-CoV-2 Panel is a covid-19 molecular diagnostic that provides results in under 2 hours.
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FDA Approves FoundationOne Liquid CDx Liquid Biopsy Test
Foundation Medicine’s FoundationOne Liquid CDx is a pan-tumor liquid biopsy test for patients with solid tumors.
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Two Viral Gene Targets Needed to Detect Covid-19 by PCR, Researchers Say
A mutation in the N gene of SARS-CoV-2 impairs the annealing of a commonly used RT-PCR primer.
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Natera’s Signatera ctDNA Assay Test Receives CE Mark
The Signatera test is a personalized, tumor-informed ctDNA assay optimized for molecular residual disease assessment and treatment monitoring.
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