Seeing ALS Through the Eye: Amydis Receives Phase 2 NIH Grant Award to Advance a Novel Approach to Detect Biomarker TDP-43

SAN DIEGO, March 11, 2026 /PRNewswire/ -- Amydis Inc., a privately held clinical-stage company pioneering a platform of ocular tracers that enable imaging of disease-related molecular biomarkers in the eye, announced today a Phase 2 grant award of $2.5 million from the National Institute on Aging at the National Institutes of Health (NIH). The award supports Amydis' novel approach to address a critical gap in medicine: the lack of a diagnostic test for TAR DNA-binding protein 43 (TDP-43) associated with neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and Limbic-predominant Age-related TDP-43 Encephalopathy (LATE).

Approximately 97% of people diagnosed with ALS have TDP-43 pathology, making it a central biological hallmark of the disease. Yet today, there is no blood test or brain scan that can directly detect TDP-43 in living patients. ALS remains a diagnosis of exclusion, often taking months or even years due to overlapping symptoms with other conditions—time that patients and families cannot afford to lose. Earlier diagnosis could accelerate access to therapeutic intervention and clinical trials, enabling more opportunities to impact disease.

To address this unmet need, Amydis is developing a non-invasive, fluorescent ocular tracer designed to function as a simple eye test capable of detecting TDP-43 using routine ophthalmic imaging technologies and workflows. Because patients routinely visit eye care providers when they notice changes in vision, this approach has the potential to integrate molecular biomarker detection of neurodegenerative disease into everyday clinical practice.

"For patients and families facing ALS and related dementias, time is everything," said Dr. Stella Sarraf, Founder and CEO of Amydis. "We believe the eye represents a new frontier in neurodegenerative disease detection. Earlier detection has the potential to change how ALS and related diseases are diagnosed, studied, and ultimately treated."

The Phase 2 grant award was based on successful completion of a Phase 1 NIH grant where Amydis demonstrated its proprietary fluorescent tracer can detect TDP-43 deposits in the retinal cadaver tissues of people with ALS, FTD and LATE. This foundational work was made possible with support from Target ALS and through collaborations with Georgetown University, Washington University in St. Louis, Mass General Brigham, Cedars-Sinai and Banner Health. The results were recently presented at the NEALS conference in November and the International Symposium on MND/ALS in December. A manuscript is being prepared for submission to a peer-reviewed journal.

This new Phase 2 grant supports continued analysis of retinal cadaver tissues to further characterize and map TDP-43 deposits, applying artificial intelligence to define disease-specific patterns across ALS, FTD, and LATE, with the goal of distinguishing these conditions at a molecular level for use in precision medicine.

"Prodromal detection of TDP-43 in people with ALS would be a step forward for our field," said Dr. Merit Cudkowicz, Executive Director of the Mass General Brigham Neuroscience Institute and Director of the Sean M. Healey & AMG Center for ALS. "A molecular biomarker test to detect TDP43 in the eye has the potential to facilitate clinical trial design and drug targeting, as well as accelerate patient enrollment in clinical trials providing earlier access to promising investigational therapies."

Research reported in this release was supported by the National Institute On Aging of the National Institutes of Health under Award Number R44AG078075. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Amydis

Amydis is leading the way for early detection of diseases through the eye that is accessible, affordable and non-invasive. The company is developing proprietary ocular tracers that enable identification of molecular biomarkers for diseases of the eye, heart and brain. Amydis is creating a data warehouse for multi-omics that includes unique molecular biomarkers of the eye to empower AI-enabled health insights. The Company's digital health solutions leverage the eye as the "window to the body" to accelerate diagnoses, enable precision treatment and improve patient outcomes. For more information contact: [email protected].

Amydis Contact:

Jessica Hoffman
[email protected] 

SOURCE Amydis Inc.