Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063906
Chunk: 338

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 338
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/2016 Title: Analysis of circulating brain -enrichedmicroRNAs as biomarkers for Rett Syndrome. The goal of this study was to assess brain -enrichedmicroRNA biomarkers in plasma samples of Mecp2 deficient male and female mice and controls. NIH/NIA SBIR Phase I Grant Number 1R43AG044860 -0107/01/2013 – 12/31/2013 Title: Early detection of Alzheimer’s disease at MCI stage by analysis of cell -freemiRNA in plasma. The goal of this study was to assess feasibility of detecting MCI patients who would progress to AD dementia and to identify microRNA biomarker candidates for differentiating Alzheimer’s disease from Parkinson’s disease. The Michael J. Fox Foundation for Parkinson’s Research Grant Number 9477 2014 Title: Analysis of circulating brain -enrichedmicroRNAs as biomarkers for Parkinson’s disease. The goal of this study was to test microRNA biomarker candidates using plasma samples collected from Parkinson’s disease patients and age -matchedcontrols from the BioFIND clinical study. IRS -QTDP2011 Title: Development of ADmiR, molecular test for early detection and monitoring of Alzheimer’s Disease. Early studies towards identification of microRNA biomarker candidates for Alzheimer’s Disease. Research & Development Strategy DiamiR intends to conduct clinical development and launch CogniMIR ®as a Laboratory Developed Test (LDT) using its CLIA -certified, CAP accredited laboratory based in New Haven CT. According to the FDA’s guidance, “a laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol, or DNA), in a sample taken from a human body. Some LDTs are relatively simple tests that measure single analytes, such as a test that measures the level of sodium. Other LDTs are complex and may measure or detect one or more analytes. For example, some tests can detect many DNA variations from a single blood sample, which can be used to help diagnose a genetic disease. Various levels of chemicals can be measured to help diagnose a patient’s state of health, such as levels of cholesterol or sodium. While the uses of an LDT are often the same as the uses of FDA -clearedor approved in vitro diagnostic tests, some labs