Fully Automated Immunoassay Analyzer The first fully automated biomarker panel for Alzheimer’s disease Mono-test cartridges facilitate runs as small as a single specimen^^^ Excellent precision leads to more reliable and reproducible results Eliminate the wastage often associated with opened reagent bottles Achieve unprecedented efficiency- by automating your entire CSF biomarker panel Disposable tip sampling ensures excellent accuracy Only one 3-point master calibration per 30 days, no need of full calibration per run Total Tau, pTau 181 Amyloid pi-42 Amyloid pi-40 Amyloid pi-42* (P) ApoE4* (P), GFAP* (P) Pan ApoE* (P) pTau 217* (P) Significantly shorter turnaround time - results within 30 minutes ALZHEIMER’S DISEASE MUST BE TREATED AT EARLY STAGE TO PROTECT THE NERVOUS SYSTEM, TO MAINTAIN COGNITIVE FUNCTION Get on board with Mispa i60 - the neuro platform of the present and the future Types and Variations of Dementia related CSF Biomarkers litem Name I Changes in AD | Significance of Biomarker Measurement Assay Characteristics * max. OPA = cut-off value for which the Overall Percentage Agreement between the clinical diagnosis and biomarker result is maximal more info about the cut-off studies can be found in the Package Inserts. (3-amyloid 1-42 Decline_ Reflects amyloid accumulation (Diagnostic (3-amyloid 1-40 Unchanging ability is improved compared to 1-42 alone by Total tau Rise Reflects the degree of neuronal damage and i Rise Reflects tau accumulation The Table is cited from guidelines for proper use of cerebrospinal fluid and blood biomarkers related to dementia. Be prepared for the future ALZHEIMER’S CASES TO TRIPLE BY 2050 The anticipated dramatic increase in the number of people with Alzheimer’s Disease compels us to prepare for it. As pioneers in this field we know that the best way to predict the future is to create it. One way of doing this is to detect Alzheimer’s earlier with new diagnostic tools. -f CLEIA principle 4 Mono-test cartridge 4 Fully automated 4 Reliable 4 Time and cost saving AUTOMATION FULFILLS NEW EXPECTATIONS At this moment there is a growing need for IVD assays that quantify these biomarkers in a reliable and highly precise manner. Mispa i60, the business alliance with Agappe and Fujirebio responds to this challenge, as well as the added pressure on the lab to speed up the delivery of results in a cost efficient way by providing full automation of industry-standard analysis. New therapeutic clinical trials on the horizon will require a standardized result with efficient workflow. The Apl-42, A|31-40, total Tau and P-Tau assays developed by Fujirebio for the Mispa i60 instrument can fulfill these demands, today and in the future. Evidence shows that the use of the A(31-42/A(31-40 ratio can improve the interpretation of the CSF biomarker profile in routine diagnostics. For clinical trial use, it has been shown that the ratio is more concordant with Amyloid-PET imaging than CSF A(31-42 alone for detecting amyloid deposition in the brain. The ratio will be calculated automatically by the Mispa i60 instrument when analyzing both markers.