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In Vitro Diagnostics News

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31-45 of 2988 results
Roche launches cobas MRSA/SA test to target healthcare-associated infections
Roche has announced the CE-IVD launch of the cobas MRSA/SA nucleic acid test for use on the cobas Liat System for the qualitative detection and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) at the point of care.
Diagnostics > In Vitro Diagnostics > News
FDA approves test for detection of certain leukemias and lymphomas
The US Food and Drug Administration has allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN).
Diagnostics > In Vitro Diagnostics > News
FDA approves companion diagnostic test to simultaneously screen for multiple NSCLC therapies
The US Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing (NGS)-based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC).
Diagnostics > In Vitro Diagnostics > News
Hologic wins FDA approval for Aptima HSV 1 & 2 molecular assay
By MDBR Staff Writer
Medical technology firm Hologic has secured approval from the US Food and Drug Administration (FDA) for its Aptima assay for the detection of herpes simplex virus (HSV) 1 & 2.
Diagnostics > In Vitro Diagnostics > News
PerkinElmer to buy Germany’s Euroimmun for $1.3bn
By MDBR Staff Writer
US-based PerkinElmer has agreed to acquire German firm Euroimmun Medical Laboratory Diagnostics for around $1.3bn.
Diagnostics > In Vitro Diagnostics > News
Mologic gets CE mark for PERiPLEX diagnostic test for peritoneal dialysis
Mologic has received CE mark approval for PERiPLEX, a rapid point-of-care test for the detection of infection in patients on peritoneal dialysis (PD).
Diagnostics > In Vitro Diagnostics > News
Thermo Fisher gets CE mark for new immunoassay for detection of buprenorphine
By MDBR Staff Writer
Thermo Fisher Scientific has secured 510(k) clearance from the US Food and Drug Administration (FDA) and CE mark for a new immunoassay to detect buprenorphine and three major metabolites.
Diagnostics > In Vitro Diagnostics > News
Sysmex to acquire Oxford Gene Technology
Oxford Gene Technology (OGT), the molecular genetics company, has signed an agreement to be acquired by Sysmex, a Japanese in vitro diagnostic company.
Diagnostics > In Vitro Diagnostics > News
Atonomics gets CE mark for Trace Lipids test panel
Atonomics, a consumer medical diagnostics company providing personal central lab standard data, has secured CE mark for its first commercial product, a Lipids test panel on its proprietary Trace platform.
Diagnostics > In Vitro Diagnostics > News
Provista’s new blood test offers improved breast cancer detection
By MDBR Staff Writer
A new study has demonstrated that a multi-protein biomarker blood test to identify breast cancer can potentially reduce use of biopsy by up to 67% in women under the age of 50.
Diagnostics > In Vitro Diagnostics > News
Luminex gets FDA approval for ARIES Bordetella assay
Luminex has secured FDA approval for the ARIES Bordetella assay for direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.
Diagnostics > In Vitro Diagnostics > News
BD offers diagnostic solutions to combat antimicrobial resistance
Becton, Dickinson and Company (BD), a global medical technology company, has announced the global distribution of a complete portfolio of products for mass spectrometry that provides high-speed and high-confidence identification of pathogens in clinical laboratories.
Diagnostics > In Vitro Diagnostics > News
GenMark gets CE mark for ePlex blood culture identification fungal pathogen panel
GenMark Diagnostics has secured CE Mark under the European In‐Vitro Diagnostic Devices Directive (98/79/EC) for its ePlex blood culture identification fungal pathogen (BCID-FP) panel.
Diagnostics > In Vitro Diagnostics > News
Abbott's acquisition of Alere to go ahead at reduced price
By MDBR Staff Writer
Healthcare firm Abbott has amended the existing agreement to acquire diagnostic device and services provider Alere.
Diagnostics > In Vitro Diagnostics > News
FDA approves Roche’s CINtec histology test to diagnose cervical disease in women
By MDBR Staff Writer
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Roche’s CINtec histology test to diagnose cervical disease in women.
Diagnostics > In Vitro Diagnostics > News
31-45 of 2988 results