Commercialization of a Diagnostic test for amyotrophic lateral sclerosis (ALS)

Award Information
Agency:
Department of Health and Human Services
Branch:
N/A
Amount:
$165,702.00
Award Year:
2013
Program:
STTR
Phase:
Phase I
Contract:
1R42NS083227-01
Agency Tracking Number:
R42NS083227
Solicitation Year:
2013
Solicitation Topic Code:
NINDS
Solicitation Number:
PA12-089
Small Business Information
IRON HORSE DIAGNOSTICS, INC.
21053 N 75TH ST, SCOTTSDALE, AZ, 85255-4771
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
78507192
Principal Investigator
 ROBERT BOWSER
 (602) 406-8989
 RBowser@IronHorseDx.com
Business Contact
 ROBERT BOWSER
Phone: (602) 810-0812
Email: RBowser@IronHorseDx.com
Research Institution
 ST. JOSEPH'S HOSPITAL AND MEDICAL CENTER, BNI
 350 WEST THOMAS ROAD
PHOENIX, AZ, 85013-
 () -
 Domestic nonprofit research organization
Abstract
DESCRIPTION (provided by applicant): Amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) is a fatal neurodegenerative disease with a typical lifespan of 3 - 5 years after diagnosis. The initial symptoms can be similar to many other neurologic disorders and often begin with limb weakness, muscle fasciculations, or increasing difficulties in speech or breathing. No definitive diagnostic tests currently exist for ALS, and clinical diagnosis typically takes 12 months from symptom onset and relies on ruling out other potential causes of the clinical symptoms. Earlier diagnosis will permit more rapid initiation of treatment with newer drug therapies in development, or equally important provide a means to rapidly rule out ALS as a cause of the symptoms. Iron Horse Diagnostics, Inc. was created to finalize the development of diagnostic and prognostic indicators of ALS and market these assays as laboratory developed tests (LDTs) in a Clinical Laboratory Improvement Amendments (CLIA) certified lab. We have produced a series of peer-reviewed publications convincingly demonstrating that significant levels of pNfH and complement c3 can be detected in the blood and CSF of ALS patients, and that the levels detected by our assays provide diagnostic utility for ALS.We propose a series of tasks to optimize and validate our assays in a CLIA certified laboratory, the last remaining steps before commercialization. This is a FastTrack application because the remaining steps before Phase III are well defined with highly definable go/no-go gates. During Phase I of the proposed work, we will finalize and optimize assays as diagnostic indicators of ALS by testing samples for indicative proteins and translating the assay technology onto a new platform. Phase II will expand onthis by conducting a multi-center prospective clinical research study and qualifying the assays using patient samples in a CLIA-certified lab to determine the overall accuracy of the ALS diagnostic. The goal of this proposal is to generate a sensitive andvalidated LDT (Lab Developed Test) for these biomarkers useful for clinically diagnosing ALS in a CLIA certified lab. A certified LDT will be marketed to clinicians as a service. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease that currently lacks a diagnostic test. Iron Horse Diagnostics has cerebrospinal fluid and blood---based diagnostic assays that in our application will be qualified, validated and commercialized as alaboratory developed test (LDT) for ALS.

* information listed above is at the time of submission.

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