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Rapid At-home Test for Monitoring Tacrolimus Levels in Plasma

Award Information
Agency: Department of Defense
Branch: Defense Health Program
Contract: W81XWH19C0085
Agency Tracking Number: A183-145-0258
Amount: $149,882.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: A18-145
Solicitation Number: 2018.3
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-05-20
Award End Date (Contract End Date): 2019-12-19
Small Business Information
2501 Earl Rudder Freeway South, College Station, TX, 77845
DUNS: 184758308
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Dr. Ritwik Ghosh
 (979) 764-2200
Business Contact
 Mrs. Taylor Blincoe
Phone: (979) 764-2200
Research Institution
Vascularized composite allotransplantation (VCA) is a surgical approach for the clinical management of non-salvagable injuries. Tissue rejection is a major issue for patients receiving VCA. Tacrolimus is the most common immunosuppressant employed to minimize tissue rejections in VCA. The safety and efficacy of tacrolimus, which has a narrow therapeutic window is particularly sensitive to proper maintenance of drug plasma levels. With the currently available tacrolimus assays, plasma level monitoring can only be performed in a clinical laboratory setting. Development of a self-test would allow patients receiving VCA to monitor plasma tacrolimus levels at home, thereby reducing logistical burdens on both the health care system and the patients. Moreover, a home test will allow more frequent monitoring, thereby minimizing incidence of tissue rejections and adverse effects. Lynntech proposes to develop an innovative non-powered, portable microfluidic format that integrates sample preparation and assay performance within the same cartridge. A smartphone-based application allows data interpretation, storage and dissemination via wireless connectivity. Thus, Lynntechs platform represents an end-to-end solution that enables target biomolecule identification/quantification in a rapid (~20 minutes) and inexpensive (<$2) assay format. Operation of the assay requires minimal to no training and can be performed at home by patient or caregiver/family member.

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