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Diagnostic Device for Detecting Biomarkers of Early Multiorgan Injury in Saliva

Award Information
Agency: Department of Defense
Branch: Defense Health Agency
Contract: W81XWH-17-C-0188
Agency Tracking Number: H2-0240
Amount: $999,999.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: DHP16-006
Solicitation Number: 2016.1
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-25
Award End Date (Contract End Date): 2020-02-24
Small Business Information
2531 West 237th Street
Torrance, CA 90505
United States
DUNS: 114060861
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 Dr. Anamika Ray
 Senior Scientist
 (310) 530-2011
Business Contact
 Kisholoy Goswami
Phone: (310) 530-2011
Research Institution

DoD requires a single, multiplexed, saliva-based diagnostic bioassay to determine multiorgan injury-relevant systemic toxicity. This assay should quantitatively-detect clinically relevant biomarkers in saliva and validate organ injury arising from chemical/xenobiotic exposure. Innosense LLC (ISL) is building on its proprietary carbon nanotube platform to construct Nano-Mos for detecting salivary biomarkers with =95 % specificity. Saliva as a non-invasively-acquired patient sample is considered the "Holy Grail" of molecular diagnostics. Its clinical utility, however, was somewhat unsubstantiated for systemic diseases until recently when salivary genome, transcriptome, proteome results have exponentially increased our knowledge. In Phase I, ISL detected cortisol as a biomarker in saliva samples in the femtomolar range within 15 minutes for indicating overall stress levels in human. In Phase II, ISL will optimize the fabrication steps with scale-up in focus, build a prototype and perform rigorous testing with saliva samples of diverse origin. ISL will formalize FDA approval steps toward market entry. Nano-Mos is ideal for detecting target molecules that are often present in low concentration in saliva compared to serum. This unique feature of Nano-Mos, coupled with uncomplicated sample processing for saliva, establishes its versatility as a fieldable diagnostic device for military personnel and first responders.

* Information listed above is at the time of submission. *

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