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In Vitro Diagnostics News

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16-30 of 2974 results
FDA approves BD’s new immunological diagnostic system
By MDBR Staff Writer
Becton, Dickinson and Company (BD) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new immunological diagnostic system.
Diagnostics > In Vitro Diagnostics > News
Quidel to buy Alere’s Triage and BNP businesses for $440m
By MDBR Staff Writer
Diagnostic testing solutions provider Quidel has agreed to acquire Alere’s Triage and BNP businesses for around $440m.
Diagnostics > In Vitro Diagnostics > News
Biocept launches new liquid biopsy test for progesterone receptor detection
Biocept has announced the commercial availability of its new liquid biopsy test for progesterone receptor (PR), which can be used for the detection and monitoring of a key biomarker in the blood of patients with breast cancer.
Diagnostics > In Vitro Diagnostics > News
Promega intends to seek FDA approval for Microsatellite Instability assay
Promega intends to seek US Food and Drug Administration approval and CE-IVD marking for a commercially available Microsatellite Instability (MSI) assay to assist oncologists and pathologists in determining colorectal cancer decisions.
Diagnostics > In Vitro Diagnostics > News
Angle’s Parsortix-based blood test shows significant effect in ovarian cancer studies
By MDBR Staff Writer
Liquid biopsy firm Angle’s Parsortix-based blood test has showed a significant effect in the US and European ovarian cancer studies, which include up to 400 patients.
Diagnostics > In Vitro Diagnostics > News
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
16-30 of 2974 results