PhenArI's CogniMune project brings clinicians and immunologists together with cytometry specialists and data and computer scientists as a single team, able to refine — and, when needed, redesign — algorithms and interfaces on the fly to address emerging challenges.
“The application includes a strong set of expertise including immunology, spectral cytometry, data science, and neurodegenerative diseases.”
An expert in immunology who will oversee the characterization and interpretation of immune cell phenotypes. Contact PD/PI for the project.
A leader in advanced flow cytometry who will ensure high-quality data acquisition and rigorous analysis. Dr. Robinson's innovations in spectral cytometry have dramatically reduced the cost of assay implementation.
Renowned for expertise in data science and algorithmic innovation; will drive the development and optimization of the computational pipelines through a subcontract with Purdue University.
A recognized authority on neurodegenerative diseases who will provide strategic guidance on clinical relevance and translational potential, with direct access to an AD patient population.
Dr. Litwin will ensure that the entire project meets all QC requirements for instrumentation, assay design and data output modules. As in all quality projects, data are excluded if significant deviations in daily quality control are observed.
Brings decades with the FDA, providing outstanding regulatory support to the project.
Dr. Jared Brosch is a board-certified neurologist with the American Board of Psychiatry and Neurology who specializes in the diagnosis and treatment of dementia-related conditions. He is passionate about working with patients and families, helping them navigate their care journey and advancing treatment options through research.
Three collaborations described in the proposal support the proposed Phase I study.
Operates the Brain Health Program, which provides access to patients treated with the FDA-approved donanemab or lecanemab. Patients undergo MRI imaging, amyloid detection in cerebrospinal fluid and APOE genotyping (Figure 2); the de-identified immunological dataset allows the solution to be validated in a real-world clinical setting.
As of November 5, 2024. The BHP also accepts referrals from general neurologists and geriatricians within the IU Health system.
Collaboration to obtain blood samples from healthy individuals for the control cohorts. All control samples will be thoroughly screened for common human pathogens, as detailed in a letter of support from Dr. Hem Sapkota at OBI.
Letter of support: Dr. Hem Sapkota, Our Blood Institute (partner contact).
Dr. Rajwa drives the development and optimization of the computational pipelines. The optimal transport methodology follows a recent manuscript from the Purdue research partners.
This project will enable a new concept of management of long-term patients by developing new testing, monitoring and ranking approaches.
Grzegorz Gmyrek, PhenArI.
The proposal revises SBIR application 1R43AG097297-01, originally filed in January 2025, and addresses the reviewers' main concerns.
Revised to cover patient sample procurement, assay optimization and validation, and regulatory considerations.
Commercialization milestones aligned with the three Specific Aims, with quantitative Go/No-Go criteria, risk assessment and mitigation strategies.
“Longitudinal analysis of changes in peripheral immune cells over time in AD patients would be informative for research purposes.”
In response, the proposed Phase I project would prospectively test whether a targeted spectral flow cytometry marker panel can detect early ARIA-related immune shifts, in treated and untreated AD patients and control cohorts.
Letters of support from partner contacts (for example Dr. Hem Sapkota, Our Blood Institute) are listed under Partners. CogniMune is a proposed research project; it is not a cleared or approved diagnostic.
Clinicians, researchers, industry partners and investors are welcome to get in touch.
