PrimeraDx, a molecular diagnostics company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its ICEPlex C. difficile assay kit and the ICEPlex system. The ICEPlex system is a multiplex real-time PCR system ...
Molecular diagnostics company Epigenomics has entered into a €5m convertible bond financing agreement with YA Global Master SPV Ltd. Pursuant to the terms of the agreement, YA Global Master SPV will purchase convertible notes with a ...
Tags: Epigenomics, Molecular diagnostics
France-based specialty diagnostic solutions provider Diaxonhit and XDx in the US, have entered into a memorandum of agreement (MoU) for the exclusive license to market and perform AlloMap Molecular Expression Testing (AlloMap) in Europe. ...
Tags: Diaxonhit Partners, Market Allomap
US-based molecular diagnostics company Insight Genetics has obtained ISO 9001:2008 certification for its quality management system. The audit, conducted by National Quality Assurance, evaluated the company's quality system that supports ...
Bruker Daltonics, a developer of mass spectrometers and sample preparation systems, has entered into a strategic alliance with molecular diagnostics company Biodesix. Under the partnership, Bruker will support Biodesix's multivariate ...
Tags: Bruker Daltonics, spectrometers, sample preparation systems
DEKRA Certification has awarded ISO 9001:2008 certification to MDxHealth's CLIA certified and College of American Pathologists (CAP) accredited laboratory in Irvine, California, US. The certification confirms that MDxHealth's quality ...
Tags: ISO Certification, MDxHealth, Health
Molecular diagnostic cancer assays developer Predictive Biosciences has named Pierre Cassigneul as the company's new chief executive officer (CEO). Prior to joining the company, Cassigneul served as board vice chairman and president and ...
Tags: Predictive Biosciences, Pierre Cassigneul, CEO, diagnostic cancer assays
Molecular diagnostics company Exact Sciences has submitted to the US Food and Drug Administration(FDA)the first module of the premarket approval(PMA)application for its stool DNA colorectal cancer screening test. The first modular ...
Tags: molecular diagnostics, Exact Sciences, PMA application
Enzo Biochem, a molecular diagnostics company, has introduced the ColonSentry blood-based risk stratification test to assess a patient's risk of having colorectal cancer. ColonSentry requires a small blood sample and utilizes RNA to ...
Tags: Enzo Biochem, ColonSentry blood-based risk stratification test
MDxHealth and PLUS Diagnostics have reached an agreement to co-promote MDxHealth's ConfirmMDx for prostate cancer in the US. ConfirmMDx is a laboratory-developed test (LDT), which assists urologists with identifying men who may safely ...
Tags: prostate cancer assay, cancer assessment, clinical research