kvejdani

There is only so much that can go into a short essay about the story and aspirations of a disruptive startup company. This story was not meant to be a scientific publication. We are working with FDA and expecting to receive approval within a year.

You can think of Darmiyan's product as a quantitative virtual microscope that, among other things, can help pharmaceutical companies come up with a disease-modifying treatment by testing the test drug on "cognitively healthy" volunteers who could potentially benefit from the drug, if it's really effective, before it's too late. Right now there is no other tool in the market to identify and monitor microscopic abnormality in cognitively healthy brains.

Darmiyan's product is NOT a probabilistic risk assessment test, and is NOT intended for use by the general public. There are already too many tests in the market for risk assessment, which are just probability numbers. Darmiyan's product is a software for quantitative assessment of micro-structural abnormality (neurodegeneration) in every voxel of brain MRI. You can think of it as a quantitative virtual microscope. Our maps and reports are not intended for use by the general public. Once we receive FDA approval in about a year or so, the Darmiyan test (software analysis of brain MRI) has to be ordered by a physician and interpreted by a physician to assist in clinical diagnosis and intervention recommendations, if any. The guidelines on Darmiyan test indications and interpretations will be determined by the medical community.

There's currently no method to screen brain tissue health at the microscopic level. Darmiyan aims to provide that tool.

We understand the level of rightful skepticism from the community given all previous failed big claims by others. There are many tests to tell you the risk of developing dementia, which is merely a "probability" number. Darmiyan's brain maps show (and measure) the actual pathology (neurodegeneration) in the brain, at microscopic resolution.

There is currently no other method to detect and quantify micro-structural abnormality in the brain at presymptomatic stages of dementia, which is one of the main reasons why all clinical trials of Alzheimer's test drugs keep failing one after another.

When a disease-modifying treatment is found using our technology (and practically impossible without it), the person who knows the status of their brain health will be the one to benefit most from the treatment before developing symptoms.

There is currently no other early-detection technology to show (and measure) microstructural abnormality in the brain before symptoms of cognitive decline. State of art Amyloid PET is extremely non-specific, with a positive predictive value of 50% (coin toss).

Somewhat correct. If you test the software with a 1000 MRI scans from people with known diagnoses, the software will diagnose ~900 of them correctly. Roughly 97% sensitivity (3% false negative) and 85% specificity (15% false positive). False positive here is not real false positive, as the software is detecting abnormality in people who are still cognitively normal.

Great question. Web upload tool is in development, will launch in a few months. Stay tuned!