FDA Grants Approval of Darmiyan's BrainSee Test for Predicting Progression of Alzheimer Disease


The newly FDA-approved AI-powered software platform BrainSee utilizes brain MRI and cognitive assessments to reportedly predict the progression of amnestic mild cognitive impairment to Alzheimer disease in 5 years.

Padideh Kamali-Zare, PhD, the founder and CEO of Darmiyan,

Padideh Kamali-Zare, PhD

This content originally appeared on our sister site, Diagnostic Imaging.

According to a new announcement, the FDA has granted the first of its kind approval for Darmiyan's BrainSee, a software platform that may predict the progression of amnestic mild cognitive impairment (aMCI) to Alzheimer disease (AD) in patients, based on a combined artificial intelligence (AI) assessment of brain MRI and cognitive assessments.1

Originally in 2021, the FDA previously granted breakthrough designation for BrainSee. The test is the first clinical application of the company's patented core proprietary technology based on over 40 years of research, powered by advanced whole-brain image analysis and medical AI. Thus, the company noted that it is a highly scalable and fully automated program that can generate an objective score to predict the likelihood of progression from aMCI to AD in 5 years.

Top Clinical Takeaways

  • BrainSee's FDA approval marks a significant leap in predicting Alzheimer progression through its innovative combination of AI assessment, brain MRI, and cognitive evaluations.
  • Darmiyan's BrainSee not only addresses the critical unmet needs of millions with aMCI but also holds the potential to substantially reduce the economic burden of AD care through early detection and personalized treatment.
  • The approval of BrainSee by the FDA signifies a transformative shift from invasive, costly biomarker-based methods to a noninvasive, accurate, and globally scalable solution, revolutionizing the landscape of AD diagnosis and care.

"Our vision is to redefine brain health screening and monitoring standards and impact the lives of patients and their family members in a meaningful way,” Padideh Kamali-Zare, PhD, the founder and CEO of Darmiyan, said in a statement.1 “BrainSee is the first product of this vision, backed by our solid technological infrastructure that is capable of driving further transformations and scalable innovations in the brain health landscape.”

READ MORE: Personalized, Multidomain Risk Reduction Strategies Show Modest Impacts on Cognition, Dementia Risk Factors

Through early screening and risk stratification with BrainSee, the test can offer patients with aMCI at risk of AD better timely and personalized treatments, according to Darmiyan. The test also aims to delay dementia onset, while reassuring patients at lower risk of progression, which may reduce the need for costly and invasive tests that contribute to financial burden.

The company noted that the test shifts the patient experience to more proactive management, which may be important in an era of emerging AD treatments where accurate prognoses can assist with determining appropriate treatment candidates. Additionally, Darmiyan noted in the release that the economic impact of BrainSee will be significant for all stakeholders in healthcare, promising to reduce the costs spent annually on AD care through better management and effective treatment.

According to the release statement from the company, the test is unique for its prognostic accuracy, patient convenience, same-day test results, and smooth integration into the clinical workflow. Currently with the availability of MRI globally, this may significantly enhance BrainSee's utility in the clinical setting. In addition, the company noted that BrainSee shifts the paradigm in aMCI care from biomarker-based methods to noninvasive and potential actionable forecasts of future improvement or progression.

Overall, the company noted that BrainSee addresses an essential unmet need in over 10 million patients in the United States and over 100 million patients worldwide who live with aMCI.1 With an aging global population, the socio-economic impact of BrainSee is expected to grow rapidly and exponentially.

1. Darmiyan Receives FDA Approval for BrainSee, the First Prognostic Test for Predicting Likelihood of Progression to Alzheimer's Dementia. News Release. Darmiyan. Published January 12, 2024. Accessed January 15, 2024. https://www.newswise.com/articles/darmiyan-receives-fda-approval-for-brainsee-the-first-prognostic-test-for-predicting-likelihood-of-progression-to-alzheimer-s-dementia
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