REAL-TIME ANALYZERS INC — Department of Defense SBIR Phase II: A18-145
REAL-TIME ANALYZERS INC — SBIR Phase II award from Department of Defense.
Phase II SBIR prototype / development signal
- Phase II is where Department of Defense funds deeper R&D after feasibility. Incumbents with Phase II history are serious competitors on adjacent topics.
- Use this award as past-performance context and to map customer organizations for STRATFI/TACFI-style transition planning.
- Obligated amount $999,997 is consistent with substantial Phase II-scale effort; compare to related awards from the same agency.
- Topic code A18-145 links this award to a solicitation family — search the same topic stem for incumbents and recompete timing.
- Amount
- $999,997
- Agency
- Department of Defense · Army
- Program / Phase
- SBIR · Phase II
- Topic
- A18-145
- Solicitation
- 18.3
- NAICS
- —
- Place of performance
- CT
- Period
- 2019-12-09 → 2022-10-02
Description
The overall goal of this proposed project (through Phase III) is to develop the Immunosuppressant Drug Monitor to measure tacrolimus at ng/mL levels in oral fluid (saliva) at-home in 10-15 minutes. The monitor will replace the painful blood and plasma tests, currently performed at hospital and clinics, that military patients, who have limb and facial transplants, must undergo to avoid transplant rejection. During the Phase I project, feasibility was demonstrated by developing a lateral-flow assay that allowed detecting tacrolimus artificially spiked in de-identified, oral fluid (saliva) at 1 ng/mL in 15 minutes. The overall goal of the Phase II project is to develop a prototype Immunosuppressant Drug Monitor to measure tacrolimus levels in patient oral fluid. The performance of the prototype device will be validated by comparing tacrolimus concentrations determined for transplant patient plasma by lab methods to concentrations determined from their oral fluid by the Immunosuppressant Drug Monitor. Samples will be obtained under the direction of Dr. Curtis Cetrulo, Director of the Vascularized Composite Tissue Allotransplantation Lab at Massachusetts General Hospital. A regulatory strategy for FDA clearance will be developed.