What is the Virtual Microscope and what is its FDA breakthrough, BrainSee?
The first Virtual Microscope, known as DarmiScope, is an advanced, AI-powered, prognostic medical image processing algorithm that analyzes human brain MRI, combines it with basic cognitive screening, scores, and provides quantitative prognosis for mild cognitive impairments. BrainSee, the first Virtual Microscope product in development with FDA breakthrough designation, provides the likelihood of progression from mild cognitive impairment to dementia within the next 5 years. BrainSee can also generate brain maps that localize and quantify microscopic changes throughout the brain.
Is there a virtual microscope for other organs?
No. Darmiyan has created DarmiScope, the first virtual microscope of biological tissues. Although the core technology is fine-tuned for the human brain, it can be calibrated for other organs as well.
How does this software resemble a microscope?
DarmiScope extracts biologically meaningful information from every voxel (3D pixel) of a brain MRI image. DarmiScope generates quantitative brain maps, non-invasively, as if the entire brain was analyzed under a microscope.
What inputs are required?
Either of the following:
- Routine clinical brain MRI, routine cognitive screening scores such as MMSE or MoCA, and an estimate of the patient’s level of impairment in the instrumental activities of daily living (e.g. an actual or estimated CDRSB); OR:
- High-resolution brain MRI including 3D T1 & DTI
Which cognitive tests enable BrainSee to work optimally?
If high-quality (research-grade) brain MRI is provided, BrainSee does not require cognitive test scores as input. If routine clinical brain MRI (relatively lower quality T1 & DWI) is provided, BrainSee will also require MMSE or MoCA, as well as an estimate of the patient’s level of impairment in the instrumental activities of daily living (e.g. an actual or estimated CDRSB).
How does the platform work?
Users will upload anonymized MRI files in DICOM or NIfTI format through Darmiyan’s website (see the homepage, BrainSee Demo). Additional information, if needed, will be requested through email correspondence. Once the processing is complete, the customer will be notified with a detailed report.
Can BrainSee be added to any MRI order?
Yes. Once clinically available, BrainSee analysis can be added to any brain MRI order to provide detailed quantitative analysis of tissue microstructural changes throughout the brain and in its major pre-defined anatomical regions, as well as a likelihood estimate of progression to dementia if the patient clinically has mild cognitive impairment. In addition to these unique proprietary analyses, BrainSee also provides the standard volumetric measurements that are provided by other commercially available software.
Can I get BrainSee analysis on an MRI I have at home or on file at my doctor’s office?
Yes, once the FDA approves. Please ask your doctor to contact email@example.com for detailed instructions.
How quickly would I get a result if we use the MRI on file and update the info with cognitive tests?
The next day.
My mom just fell again. If she can do a visit via telemedicine with her doctor, can BrainSee help me figure out what’s going on?
Potentially, if her doctor deems it necessary to get a brain MRI and perform BrainSee analysis on it. However, it’s important to recognize BrainSee is available for research use only until it receives FDA approval. In 2021 the FDA granted Darmiyan the breakthrough designation for BrainSee, to expedite its market entry.
How does BrainSee compare to the new tau blood test under development?
Tau blood test is at least 5 years away from commercialization, and its value for predicting progression from MCI to dementia remains unknown. As of now, it can only help determine whether dementia (latest stage of neurodegeneration) is due to a tauopathy (Alzheimer’s disease, FTD, CTE, PSP, CDB, senile dementia, etc).
How does the DarmiScope compare to PET?
Different PET tracers (FDG, Amyloid, and Tau) are occasionally used for differential diagnosis of the possible cause of dementia, which is the latest stage of most neurodegenerative diseases. PET scan is a relatively poor predictor of MCI prognosis.
How does the DarmiScope compare to NeuroQuant or NeuroReader or any other MRI-based brain volumetry software?
MRI-based brain volumetry using NeuroQuant, NeuroReader, or similar equivalent software, measures tissue shrinkage (atrophy) that happens when millions of brain cells are already dead, resulting in a decreased volume of the brain tissue. Such a shrinkage happens at much later stages of the disease process, which is too late for an effective diagnosis and possible intervention. Volumetry at the mild cognitive impairment stage is NOT a useful predictor of progression to dementia.
In contrast, the DarmiScope’s BrainSee measures early microscopic changes in the brain tissue before there is any detectable atrophy. This is why BrainSee is a breakthrough product and such a powerful predictor (with high sensitivity and specificity) of progression to dementia at much earlier stages of mild cognitive impairment.
Are you quantifying brain health? I heard brains evaluated with BrainSee get a grade.
That is correct. BrainSee provides a prognostic numeric measurement for patients with mild cognitive impairment, that predicts the likelihood of progression to dementia in the next 5 years.
What is measured?
Neurodegeneration at both microscopic and macroscopic levels.
How/why did you choose this form of evaluation?
Microscopic evaluation of brain tissue using MRI is a powerful novel technique developed by Darmiyan. It has been non-existent in the market. Its illumination of prodromal Alzheimer’s disease is unique.
Would you call BrainSee a risk prediction tool?
Yes, BrainSee can quantify the risk of progression from MCI to dementia in 5 years.
If I don’t have amnestic MCI, but I do have mild cognitive impairment, can Darmiyan tell me which MCI I have?
Potentially. Although BrainSee has not been fully tested for differentiating different subtypes of MCI, its quantitative whole brain maps can help the physician with the differential diagnosis.
How do you feel about illuminating neurodegeneration so noninvasively and specifically – some say it’s close to discovering holy grail of the field?
It’s been a thrilling journey and very exciting times, especially with AD therapeutics coming to the market and renewed interest in developing them. Darmiyan’s BrainSee is poised to not only fill major diagnostic and prognostic gaps, but also guide proper treatment. We look forward to working with FDA to secure approval.
What kinds of MCI patterns have you identified that doctors could not previously detect?
We have discovered new patterns of abnormality in the brain that haven’t been previously described in the dementia literature. Details will be published in peer-reviewed scientific journals for the medical community.
When do you think my coach or teammate will be able to use the DarmiScope to see if I have a concussion?
Potentially. Darmiyan is open to doing research on that.
What is Darmiyan’s original product?
Darmiyan’s original product, BrainSee, is an advanced medical image processing software platform for the early detection of Alzheimer’s disease and other neurodegenerative diseases using standard clinical brain MR (magnetic resonance) images.
What is breakthrough about BrainSee?
BrainSee takes the patient’s age, sex, cognitive assessment, and MRI scan files as input, and swiftly generates the cognitive diagnosis and prognosis as output. It is novel software for noninvasive detection and monitoring of Alzheimer’s disease at the early stage of mild cognitive impairment (MCI). Darmiyan’s AI solution can reliably guide physicians on clinical management of MCI patients.
What’s novel about this technology?
The technology is based on many years of detailed computer simulations of brain tissue micro-structure using advanced modeling & simulation techniques that rely on over 40 years of neuroscience research. This is the first non-invasive technology that provides precise quantification and localization of microscopic abnormality in the brain. It combines the latest in computational neuroscience and digital health technologies (AI/ML) to medical imaging to provide a unique enterprise software solution.