Neurological emergencies are common and often devastating. Every year, millions of Americans suffer from either an acute stroke, a traumatic brain injury (TBI), hemorrhage or spinal cord injury severe enough to require medical intervention. Evaluation of diseases in the acute setting frequently requires advanced diagnostics and treatment in a hospital or specialized center. Neurodegenerative diseases (e.g. , Parkinson's, Alzheimer's diseases) require imaging and repeated testing, even though body fluid biomarkers are on the horizon. These are likely based on blood tests, which are unpractical, somewhat invasive, and require medical personnel and equipment.

The goal of our project is to develop devices for rapid point-of-care measurement in the salivary fluid of the brain-derived protein S100B or other suitable protein analytes in individuals at risk of neurological diseases. Our IP covers all brain proteins measurable in saliva with a molecular weight of less than 60 kD. Our invention is based on the discovery of brain-derived protein that will show up in saliva based on an algorithm developed by us.

Current blood-based approaches require venipuncture, the involvement of a phlebotomist or medical personnel, and several steps of blood separation to obtain plasma or serum. Our test can be self-administered, similar to a COVID antigen-based test. This is the first study measuring salivary proteins which are brain-derived. We have a prototype for a saliva-based POC test for S100B. The same device can easily measure other analytes. This is the first attempt to manufacture a saliva test that can be used at home without specific training or need for intervention by medical personnel (consumer product). The test is based on immunodetection of the selected antigen in less than a teaspoon of saliva. Completion of the test occurs within 15 minutes.

We have extensively published on the use of blood S100B in the detection of neurological diseases, including brain tumors, psychiatric illness, and traumatic brain injury in sports or other causes. We now wish to collect salivary samples from selected diseases where any of the analytes covered by IP may have an etiologic or diagnostic potential. For example. we are completing a study where two brain proteins will be measured in saliva to determine their value in predicting neurological problems in hospitalized COVID patients. Our first-ever study on salivary biomarkers in the diagnosis of traumatic brain injury has been published.

As there is increasing demand for brain diagnostics, our modus operandi is, in part, to let others discover blood biomarkers to then adapt the antigen, if measurable, for salivary testing. We will also initiate ad hoc studies skipping the blood test step. Saliva can be obtained non-invasively, and no specialized individuals need to present.

The testing strip uses a lateral flow chamber design, similar to home-based COVID tests.

Saliva does not need processing, and the sample is measured immediately after the sampling. No equipment whatsoever is required.

We propose to join forces with top medical centers worldwide to enroll patients with chronic or acute diseases, including infectious diseases in developing countries where resources are sparse.