Biocartis Group NV announced the publication of ten performance studies of its fully-automated molecular diagnostics Idylla™ platform at the annual meeting of the ‘Association for Molecular Pathology’ (AMP), a leading molecular diagnostics conference taking place virtually this year between 16-20 November 2020. The respective Idylla™ studies once again highlight the strengths of the Idylla™ platform and assays1 in terms of performance, ease of use and turnaround time, as well as Idylla™’s capacity to overcome the obstacles of working with small amounts of sample, which represents a major challenge for many current molecular testing methods in a variety of different cancer types. Furthermore, three studies discuss new Biocartis assays in the area of infectious disease: the Idylla™ SARS-CoV-2 Assay and the SeptiCyte® RAPID on Idylla™. The published oncology studies include the Idylla™ MSI, EGFR, ctEGFR, KRAS and ctKRAS Mutation Assays: The Memorial Sloan Kettering Cancer Center (New York, US) study2 evaluated the performance of the Idylla™ MSI Assay across different tumor types (pan-cancer) including endometrial, colorectal, prostate, small bowel and breast cancer. Data presented showed equivalency to Immunohistochemistry (IHC)3 and a greater sensitivity compared to MSK-IMPACT™, a Next Generation Sequencing (NGS) test, where the Idylla™ MSI Assay provided definitive results for numerous indeterminate cases. The University of Alabama at Birmingham (Birmingham, Alabama, US) study4 showed 100% agreement between the Idylla™ MSI Assay and IHC using prostatectomy specimens and describes the Idylla™ MSI Assay as a reliable option for MSI testing in high-grade prostate cancer. The Dartmouth-Hitchcock Medical Center (New Hampshire, US) study5 showed the feasibility of the Idylla™ MSI Assay to identify Lynch Syndrome6 using colorectal adenomas. Two Massachusetts General Hospital (Boston, Massachusetts, US) studies showed how rapid testing with Idylla™ can complement comprehensive PCR/NGS7 workflows, based on testing with the Idylla™ EGFR Mutation Assay and the Idylla™ ctKRAS Mutation Assay. Both studies show a reduction of the turnaround time with Idylla™ testing by approximately 50% or more, next to its ease of use and usefulness to provide for results when NGS fails. Another University of Alabama at Birmingham (Birmingham, Alabama, US) study9 evaluated the performance of the Idylla™ KRAS Mutation Assay using de-stained cytology smears of lung non-small cell carcinoma (NSCLC) cases as an alternative source to rescue limited quantity samples. Comparison with previous NGS results showed 100% concordance. The Dartmouth-Hitchcock Medical Center (New Hampshire, US) study10 evaluated the Idylla™ ctEGFR Mutation Assay on samples with DNA concentrations insufficient for NGS. Results showed a majority of samples successfully tested at a concentration of less than 40 ng DNA. In addition, three studies discuss new Biocartis products in the area of infectious disease: The Dartmouth-Hitchcock Medical Center (New Hampshire, US) study11 evaluated the Idylla™ SARS-CoV-2 Assay showing 100% concordance with their reference method. Biocartis’ partner Immunexpress will present two abstracts12 demonstrating that the new SeptiCyte® RAPID on Idylla™ correlates strongly with Immunexpress’ existing SeptiCyte® LAB test, is reproducible, and can be used not only to differentiate patients with bacterial and viral, but also candida sepsis13 from clinical controls.