SBIR-STTR Award

Project isoPTE: Isothermic Post-Traumatic Epilepsy Mirna Biomarker Detection
Award last edited on: 3/2/2021

Sponsored Program
SBIR
Awarding Agency
NIH : NINDS
Total Award Amount
$618,086
Award Phase
2
Solicitation Topic Code
853
Principal Investigator
Sarjubhai Amratbhai Patel

Company Information

FYR Diagnostics LLC

1121 East Broadway Street MonTEC Suite 155
Missoula, MT 59802
   (214) 748-3647
   N/A
   www.fyrdiagnostics.com
Location: Single
Congr. District: 01
County: Missoula

Phase I

Contract Number: 1R43NS113682-01
Start Date: 9/1/2019    Completed: 8/31/2021
Phase I year
2019
Phase I Amount
$333,824
Acquired epilepsy results from acute brain injury, such as traumatic brain injury (TBI). Acquired epilepsy is a major public health issue with inadequate treatment and diagnostic options. There are no biomarkers that assist in the prediction or diagnosis of acquired epilepsy. Project isoPTE will use two animal models of epilepsy to determine whether plasma microRNA (miRNA) biomarkers can predict or diagnose epilepsy caused by brain injury. miRNA expression is reliably altered in both experimental and clinical epilepsy and can be used to differentially diagnose epilepsy and determine TBI severity. We hypothesize that plasma miRNA have biomarker utility in PTE. This project will be the first to rigorously test this hypothesis. The isoPTE assay will be comprised of FYR DiagnosticsÂ’ proprietary UDAR (Ultrasensitive DNA Amplification Reaction) isothermal chemistry and a set of PTE-associated miRNAs. Our novel assay will meet the unmet needs to diagnose PTE. This project has strong commercialization potential and can lead to marketable products. Successful results will demonstrate that miRNA can rapidly and accurately predict and/or diagnose epilepsy. This will provide rationale for subsequent human studies.

Public Health Relevance Statement:
Project Narrative Acquired epilepsy results from acute brain injury, such as traumatic brain injury. There are no biomarkers that assist in the prediction or diagnosis of acquired epilepsy. Project isoPTE will be the first study to determine whether blood microRNA (very short oligonucleotides) can predict or diagnose acquired epilepsy.

NIH Spending Category:
Biotechnology; Brain Disorders; Epilepsy; Injury (total) Accidents/Adverse Effects; Injury - Trauma - (Head and Spine); Injury - Traumatic brain injury; Neurodegenerative; Neurosciences

Project Terms:
Acute Brain Injuries; Animal Model; Animals; Biological Assay; Biological Markers; biomarker performance; Blinded; Blood; Blood specimen; Brain Injuries; Chemistry; Chronic; Clinical; commercialization; Detection; Development; Diagnosis; Diagnostic; Differential Diagnosis; DNA amplification; Epilepsy; Epileptogenesis; experimental study; Human; Individual; Lead; Logistic Regressions; microRNA biomarkers; MicroRNAs; miRNA expression profiling; Modeling; novel; Oligonucleotides; Plasma; Post-Traumatic Epilepsy; pre-clinical; prospective; Public Health; Reaction; Receiver Operating Characteristics; RNA; Sensitivity and Specificity; Severities; Technology; Testing; Time; Traumatic Brain Injury; Validation

Phase II

Contract Number: 5R43NS113682-02
Start Date: 9/1/2019    Completed: 8/31/2021
Phase II year
2020
Phase II Amount
$284,262
Acquired epilepsy results from acute brain injury, such as traumatic brain injury (TBI). Acquired epilepsy is a major public health issue with inadequate treatment and diagnostic options. There are no biomarkers that assist in the prediction or diagnosis of acquired epilepsy. Project isoPTE will use two animal models of epilepsy to determine whether plasma microRNA (miRNA) biomarkers can predict or diagnose epilepsy caused by brain injury. miRNA expression is reliably altered in both experimental and clinical epilepsy and can be used to differentially diagnose epilepsy and determine TBI severity. We hypothesize that plasma miRNA have biomarker utility in PTE. This project will be the first to rigorously test this hypothesis. The isoPTE assay will be comprised of FYR DiagnosticsÂ’ proprietary UDAR (Ultrasensitive DNA Amplification Reaction) isothermal chemistry and a set of PTE-associated miRNAs. Our novel assay will meet the unmet needs to diagnose PTE. This project has strong commercialization potential and can lead to marketable products. Successful results will demonstrate that miRNA can rapidly and accurately predict and/or diagnose epilepsy. This will provide rationale for subsequent human studies.

Public Health Relevance Statement:
Project Narrative Acquired epilepsy results from acute brain injury, such as traumatic brain injury. There are no biomarkers that assist in the prediction or diagnosis of acquired epilepsy. Project isoPTE will be the first study to determine whether blood microRNA (very short oligonucleotides) can predict or diagnose acquired epilepsy.

Project Terms:
Acute Brain Injuries; Animal Model; Animals; Biological Assay; Biological Markers; biomarker performance; Blinded; Blood; Blood specimen; Brain Injuries; Chemistry; Chronic; Clinical; commercialization; Detection; Development; Diagnosis; Diagnostic; Differential Diagnosis; DNA amplification; Epilepsy; Epileptogenesis; experimental study; Human; Individual; Lead; Logistic Regressions; microRNA biomarkers; MicroRNAs; miRNA expression profiling; Modeling; novel; Oligonucleotides; Plasma; Post-Traumatic Epilepsy; pre-clinical; prospective; Public Health; Reaction; RNA; ROC Curve; Sensitivity and Specificity; Severities; Technology; Testing; Time; Traumatic Brain Injury; Validation