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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
SHL to Host Webinar on Value of New Technology in Drug Delivery
SHL Group has announced that it will be holding a webinar discussing the value of new technologies in digital health and drug delivery systems on June 29.
Diagnostics > In Vitro Diagnostics > Press Releases
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

MDBR Supplier Recommendations

STERISYS - Your Solution and Service Provider for Industrial Sterilisation
STERISYS is the European leader in industrial EO sterilisation and offers a wide range of solutions to medical device manufacturers and sterilisation service providers.... Diagnostics > In Vitro Diagnostics > Suppliers
LRE Medical - Transforming Ideas into Successful Products for 50+ Years!
LRE Medical GmbH, founded in 1961, is part of the Esterline Technologies Group. It is an award-winning full-service contract provider with creative ideas, expert market knowledge and 50+ years of experience in design, development and manufacturing of precision instrumentation (laboratory, molecular diagnostics, point-of-care, handheld) around existing and innovative technologies.... Diagnostics > In Vitro Diagnostics > Suppliers
SHL Group - Pen Injectors, Autoinjectors and Inhaler Systems
SHL is a privately-owned developer, designer and manufacturer of advanced drug delivery devices.... Diagnostics > In Vitro Diagnostics > Suppliers
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