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In Vitro Diagnostics News

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1-15 of 3006 results
SD Biosensor partners with PATH to advance diagnostic test for malaria
By MDBR Staff Writer
South Korean in vitro diagnostics firm SD Biosensor has collaborated with a nonprofit organization PATH to advance the development and availability of new diagnostic test for malaria treatment.
Diagnostics > In Vitro Diagnostics > News
Gold Standard Diagnostics gets FDA nod for Borrelia burgdorferi IgG/IgM ELISA assay
By MDBR Staff Writer
Gold Standard Diagnostics (GSD) has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Borrelia burgdorferi IgG/IgM ELISA assay.
Diagnostics > In Vitro Diagnostics > News
Luminex starts clinical trials for VERIGENE II gastrointestinal assay
Luminex has started clinical studies for the gastrointestinal (GI) assay on the VERIGENE II system.
Diagnostics > In Vitro Diagnostics > News
Agilent companion diagnostic wins expanded FDA approval in cervical cancer
Agilent Technologies announced that the US Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use.
Diagnostics > In Vitro Diagnostics > News
FDA approves Fujirebio's Lumipulse G B•R•A•H•M•S PCT assay
By MDBR Staff Writer
Fujirebio Diagnostics, a consolidated subsidiary of Miraca Holdings, has secured approval from the US Food and Drug Administration (FDA) for its Lumipulse G B•R•A•H•M•S procalcitonin (PCT) assay to be tested on Lumipulse G1200 immunoassay platform.
Diagnostics > In Vitro Diagnostics > News
Microbiotica, Genentech enter into $534m IBD collaboration
By MDBR Staff Writer
Microbiotica has partnered with Genentech to discover, develop and commercialize biomarkers, targets and medicines for inflammatory bowel disease (IBD).
Diagnostics > In Vitro Diagnostics > News
NantHealth unveils next-generation tool for blood-based tumor profiling and quantitative monitoring
NantHealth, a member of the NantWorks ecosystem of companies, has unveiled next-generation tool for blood-based tumor profiling and quantitative monitoring, Liquid GPS.
Diagnostics > In Vitro Diagnostics > News
Molecular Health launches Version 3.0 of software solution for precision medicine
By MDBR Staff Writer
Molecular Health has introduced Version 3.0 of Molecular Health Guide (MH Guide) software solution, offering enhanced support for precision medicine.
Diagnostics > In Vitro Diagnostics > News
Sanofi to use Adaptive’s NGS-based assay in isatuximab multiple myeloma trials
By MDBR Staff Writer
Sanofi has agreed to use Adaptive Biotechnologies’ next generation sequencing (NGS) based assay in its active and future multiple myeloma (MM) trials with isatuximab.
Diagnostics > In Vitro Diagnostics > News
Study shows Idylla EGFR mutation test is viable alternative to NGS lung cancer tests
By MDBR Staff Writer
Biocartis Group’s study has demonstrated that Idylla EGFR mutation test is a viable alternative to next generation sequencing (NGS) lung cancer tests.
Diagnostics > In Vitro Diagnostics > News
DxTerity secures CE Mark for REDI-Dx radiation biodosimetry test
DxTerity Diagnostics has secured CE mark for the REDI-Dx radiation biodosimetry test for the quantitative estimation of the absorbed ionizing radiation dose after a nuclear event.
Diagnostics > In Vitro Diagnostics > News
Myriad Genetics to buy genetic testing services provider Counsyl
By MDBR Staff Writer
Myriad Genetics has agreed to acquire genetic testing and DNA analysis services provider Counsyl in a deal worth around $375m.
Diagnostics > In Vitro Diagnostics > News
Merck, Foundation Medicine form immuno-oncology companion diagnostics collaboration
By MDBR Staff Writer
Merck has partnered with Foundation Medicine to develop a pan-cancer companion diagnostic for its Keytruda immunotherapy.
Diagnostics > In Vitro Diagnostics > News
BioGX launches six CE-Mark tests for meningitis and antibiotic resistance
BioGX has launched six additional CE-Mark infectious disease tests on Becton, Dickinson and Company's BD MAX Sample-to-Answer platform.
Diagnostics > In Vitro Diagnostics > News
Agilent launches real-time, live-cell ATP Rate assay kit
Agilent Technologies has introduced Agilent Seahorse XF Real-Time ATP Rate Assay Kit, a new product that will allow biologists to improve their understanding of how live-cells function in real-time.
Diagnostics > In Vitro Diagnostics > News
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