In nearly every area of medicine, biological evidence is imperative for diagnosis and treatment of a medical condition. However, development and use of therapies for psychiatric and many neurologic disorders have not benefited from biological brain-based evidence in practice, despite many years of research, due to both scientific and platform limitations. Current practice relies on subjective reports and trial and error treatment.
Biomarkers created a revolution in the ability to develop and deploy treatment in specialties such as cardiology and oncology. After decades of research, functional (fMRI) is effective in showing neural activity in the brain, but commercial translation has not been successful—until now.
Biological measurement of mechanism and markers of treatment effect
Drug and device developers and clinicians often observe symptoms or rely on self-reporting to determine treatment efficacy. However, a biological basis is critical to complement the current practice of patient interviews to create a comprehensive patient-specific view.
Disease segmentation
There is tremendous variability within, and overlap among, psychiatric diagnoses. Biological evidence would help segment disease subtypes to allow for more effective treatment. The ability to cohort patients would enable better therapeutic solutions for underserved populations.
Ceretype is a services, platform, and insights company that can provide the intelligence needed to deliver an actionable brain biomarker.
Brain Insight Report
Our first solution—available as a scalable platform or for a specific use case/indication—is a functional brain map at the individual patient level unlike anything currently available. Our technology enables accurate, reliable, reproducible measurement of brain activity in the regions that are critically involved in psychiatric and neurological disease and their response to treatment.
All-In-One Cloud Based Platform
Ceretype’s powerful, integrated cloud-based platform translates our insights into actionable results for drug developers, and we are making these capabilities compatible with a clinical setting. The platform allows quantitation of fMRI images using advanced technology and algorithms to correct artifacts that have previously limited the translation of the modality. This results in reliable, reproducible results across scanners, sites and individuals, and it provides capabilities and services that have not been possible at scale in industry and healthcare before.
Decision Support
Clear metrics assess brain function in multiple dimensions for multiple use cases, such as circuit activity in time, circuit activity over time, and number of active circuits.
Key Applications
Our solution is agnostic to disease type and intervention, and initial applications are focused, for example, on anxiety and mood disorders and neurodegenerative disease.
In Development
Available Now
Precision
Ceretype creates maps of brain activity and circuitry, with resolution to the millimeter scale, in any patient no matter their age or diagnosis. When this information is acquired at several time points for a patient (longitudinally), it allows us to determine the treatment effects of a drug.
Precise measurement over time
Ceretype creates maps of brain activity and circuitry, with resolution to the millimeter scale, in any patient no matter their age or diagnosis. When this information is acquired at several time points for a patient (longitudinally), it allows us to determine the treatment effects of a drug.
Comparison
Ceretype will be able to assess whole-brain, region-specific, circuit-specific measurements of function and connectivity and compare them to normal, age-specific background values to understand how brain activity progressively changes over timescales of minutes to months or years.
Specificity
Ceretype optimizes clinical trials by creating neural circuit maps that are specific to the needs of the trial. We can identify a specific region of interest (dopamine circuits, for example) or map the whole-brain circuitry that is responsible for a domain of function affected by a drug or device, such as the brain regions and networks associated with depression treatment.
Broad applicability
Ceretype’s solution is disease- and patient-agnostic and can be used for any person of any age with any disease, and it will provide accurate and specific insights at the individual level through best-in-class technology.
Platform
Through its biomarker engine, Ceretype is continuously analyzing data and developing metrics and reports that meaningfully convey states of brain health and disease. The platform can assess disease or treatment response or inform brain health.
Platform
Through its biomarker engine, Ceretype will have the ability to continuously analyze data-developing metrics and reports that meaningfully convey states of brain health and disease—purpose-oriented for a disease or treatment or generally informative of brain health.
Integration
Ceretype’s imaging data integrates with the rest of acquired trial data, such as behavioral interviews, electrophysiology, structural imaging, peripheral markers, and others in complementary manner. Our imaging and data systems are unique due to the technical specifics of how we acquire and analyze data. This gives us a razor-sharp understanding of the contents of the data and what their biological origins are.
Ceretype’s systems are also fully interoperable with current and future AI and data systems, including clients’ own algorithms. This information can not only validate a positive finding but can help understand the broader set of effects from a drug and give insights that may help identify poor responders early in a treatment course.
Integration
With the ability to integrate compliantly into any RIS or DICOM system and full interoperability with current and future AI or data systems, including clients’ own algorithms, the platform will create clear reporting on treatment response. We are building a data infrastructure that will be actionable in clinics and ongoing clinical studies to validate patients and payers.
DISCLAIMER: The above statements regarding the clinical application, which is under development, have not been evaluated by the Food and Drug Administration.