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BG Medicine files for expanded indication of BGM Galectin-3 test
BG Medicine has filed 510(k) premarket notification for regulatory clearance of an expanded indication for its BGM Galectin-3 test with the FDA.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
Critical Diagnostics appoints two new distributors in Asia Pacific region
Critical Diagnostics has announced two new distribution partners for cardiac biomarker test, the Presage ST2 assay, in the Asia Pacific region.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
ZyGEM to integrate enzymatic technology into Quanta PCR kits
ZyGEM has signed an agreement to integrate its enzymatic RNA extraction technology into Quanta Biosciences' kits for quantitative PCR.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
Ariosa announces availability of Harmony prenatal test in US, Canada
Ariosa Diagnostics has announced the availability of Harmony prenatal test in the US and Canada through Laboratory Corporation of America Holdings (LabCorp) and Integrated Genetics.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
JS Genetics launches new XCAT-KS buccal swab test
JS Genetics has launched a new proprietary buccal swab test, XCAT-KS, to diagnose Klinefelter syndrome (KS) and other male sex chromosome aneuploidies.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
FDA approves Clostridium difficile molecular diagnostic test
The FDA has granted approval for Great Basin's first molecular diagnostic test for Clostridium difficile (C. diff).
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
MDxHealth enters marketing deal with PLUS Diagnostics
MDxHealth and PLUS Diagnostics have reached an agreement to co-promote MDxHealth's ConfirmMDx for prostate cancer in the US.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
Roche unveils sequencing assays to identify genetic variations in leukemia samples
Roche has unveiled GS GType TET2/CBL/KRAS and GS GType RUNX1 primer set for high sensitivity genetic variant detection in leukemia samples.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
Saladax signs distribution contract for My5-FU diagnostic test in Egypt, MENA region
Saladax Biomedical has signed a diagnostic agreement with Eilaf Pharma for My5-FU diagnostic test in Egypt and throughout the Middle East North African (MENA) region.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
ProImmune unveils B cell ELISpot assay
ProImmune has introduced B cell ELISpot assay as a service for the characterization of adaptive immune responses to infection, immune modulators, vaccines and therapeutic agents.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
MicroPhage KeyPath test gains expanded FDA clearance
MicroPhage has gained an additional FDA 510 clearance for its KeyPath MRSA/MSSA Blood Culture Test-BT.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
Quest gains FDA clearance for Simplexa C difficile molecular test
Quest Diagnostics has received FDA 510(k) clearance for its Simplexa C difficile Universal Direct Test on the 3M Integrated Cycler.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
Enzo Biochem introduces colorectal cancer diagnostic test
Enzo Biochem, a molecular diagnostics company, has introduced the ColonSentry blood-based risk stratification test to assess a patient's risk of having colorectal cancer.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
Stellar launches anti-KLH ELISA assays for pharmaceutical immunotoxicology research
Stellar Biotechnologies, a manufacture of Keyhole Limpet Hemocyanin (KLH), has launched Stellar KLH enzyme-linked immunosorbent assay (ELISA) test kits for pharmaceutical immunotoxicology research.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News
Quidel gains CE mark for Direct C difficile Tox A/B assay
Quidel has gained CE mark for the Quidel Molecular Direct C difficile Tox A/B assay to detect toxigenic Clostridium difficile bacterial DNA.
Automation > Laboratory Instrumentation > News
Automation > Laboratory Instrumentation > News