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In Vitro Diagnostics

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
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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
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