Werfen has received FDA 510(k) clearance and CE mark for its Aptiva APS IgA reagent, completing its antiphospholipid syndrome testing portfolio for IgA, IgG, and IgM on the Aptiva automated multi-analyte platform.
Siemens' Innovance Antithrombin assay has received FDA clearance as a companion diagnostic test for patients treated with Qfitlia.
The TaqPath COVID-19 Diagnostic PCR Kit enables labs to adopt a validated in vitro diagnostic workflow for SARS-CoV-2 detection.
These reagents, the HISCL β-Amyloid 1-42 and 1-40 assay kits, have attained CE-IVD marking as of May 17, 2022.
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The K-ASSAY Microalbumin reagent is intended for the quantitative determination of human albumin in urine by immunoturbidimetric assay.
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Werfen announced 510(k) clearance of Aptiva Connective Tissue Disease (CTD) Essential reagent by the U.S. Food and Drug Administration (FDA).
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The U.S. FDA cleared the chromogranin A test and immunoassay for the assessment of tumor progression in GEP-NET patients.
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The digital PCR assay kit co-quantifies respiratory pathogens SARS-CoV-2, influenza A, influenza B, and RSV.
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OnsiteGene has developed a sample-to-answer instrument that is designed to improve PCR testing, the PeakV.
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Absolute Biotech, a company uniting multiple antibody-centric brands into a single organization, is reintroducing SCICONS dsRNA antibodies.Â
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T2 Biosystems, Inc.,has submitted a 510(k) premarket notification to the FDA for the Company’s T2Biothreat Panel.
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U.S. Healthcare professionals can access a new novel NAD+ blood diagnostic test for their patients, following the new partnership.
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OncoHost, a diagnostics company centered on predictive biomarker development patient care, launched its non-small lung cancer (NSCLC) test.
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Beckman Coulter and MeMed are developing a diagnostic assay able to distinguish between bacterial and viral infections.
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BioSPME (Bioanalytical Solid Phase MicroExtraction), has been developed to provide a high throughput automatable cleaner sample
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The liquid biopsy ctDx FIRST test is FDA approved as a companion diagnostic for advanced non-small cell lung cancer (NSCLC) patients.
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BD and CerTest Biotec have announced EUA from the U.S. Food and Drug Administration (FDA) for a molecular PCR assay for Mpox virus detection.
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Clinical labs learned about the limitations of mpox testing during last summer’s outbreak, taking away valuable lessons.
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