Artera has received CE marks under EU IVDR for its AI-powered prostate and breast cancer assays, enabling clinical use of these prognostic and predictive tests in the European Union and other territories, the company announced.
Veracyte and Illumina will develop high-performing molecular tests as decentralized IVD tests on Illumina’s NextSeq 550Dx NGS instrument.Â
Devyser Compact is a rapid genetic test for prenatal chromosome testing and is approved under the new more comprehensive regulation.
Industry experts predict a year of change and transformation ahead as the COVID-19 pandemic continues to influence the way clinical labs operate.
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EKF Diagnostics announces that it has acquired Advanced Diagnostic Laboratory LLC, a Texas based PCR-focused testing laboratory.
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The HiScribe in vitro transcription kit from New England Biolabs incorporates TriLink Biotechnologies’ CleanCap technology for mRNA synthesis.
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Thermo Fisher Scientific has expanded its diagnostics portfolio to support full qPCR assay development and testing workflow.
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The in-person 2021 AACC Annual Scientific Meeting & Clinical Lab Expo drew thousands of laboratory medical professionals to Atlanta from September 26 to 30.
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Certain temporary deviations in FDA policy in response to the COVID-19 pandemic may offer a blueprint for regulatory oversight of LDTs.
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BioCheck, Inc. has acquired DRG International, a manufacturer of clinical diagnostic and research...
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Accelerate Diagnostics, Inc. has launched a new IVD configuration of its Accelerate PhenoTest BC kit in the United States.
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BBI Solutions launched a new Jo-1 human chimeric antibody for use as a calibrator or positive control in assays.
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The high-performing qPCR system’s simplified, efficient workflow minimizes steps to deliver quality results in as little as 30 minutes.
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Illumina’s NextSeq 550Dx platform and associated reagent kits received medical device registration in Russia, as have reagents for the MiSeqDx.
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Tecan has become one of the first companies to meet the requirements of the European Union’s IVDR, successfully completing certification of its IBL International DHEA Saliva ELISA diagnostic assay kit.
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The acquisition will combine the Horiba Medical’s technology with MedTest Dx technology, Clinitox, and Pointe Scientific’s research and development and manufacturing capabilities.
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When cleared, the FDA-designated breakthrough device is expected to be among the first commercially available in vitro diagnostics for patients being evaluated for Alzheimer’s disease in the United States.
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SeptiCyte Rapid distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis and provides actionable results in about 1 hour.
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