Tuesday, May 13, 2025
5/13/2025
The Transfusion Chip: Phase II Technology Validation - DESCRIPTION (provided by applicant): Blood-Typing is the progenitor of the entire field of personalized medicine. In the recently awarded 6-month Phase I, we proposed to take the first step in the development of an extremely-low-cost microarray test, "The Transfusion-Chip" (T-Chip) which convert the historical practice of Blood-Typing by serology into a simple inexpensive DNA test. Here, in this follow-on Phase II, we demonstrate substantial success in achieving key Phase I milestones: we have developed and optimized 22 PCR reactions, comprising the entire 7 gene blood group gene set [ABO, Rh, Duffy, Kidd, Kell, Dombrock & MNS]; we have fabricated a Transfusion-Chip microarray prototype capable of analyzing all known genetic variation in the 7 gene set; and via technology that we had not yet invented when we filed the Phase I, we have developed a new variant of the original GenUSA microarray test which will drop the manufacturing cost of T-Chips to values as low as $1 per microarray. In Phase I we have also shown that the raw, unpurified OrageneTM-stabilized saliva can used as the basis for DNA based Blood-Typing on the T-Chip. We feel that the coupling of raw OrageneTM-stabilized saliva collection with the low cost T-Chip could become a unique technology pairing: because it would allow self-collection of DNA samples, at home, then low- cost ambient temperature shipping to centralized labs, to be followed by very-low-cost, very high throughput Blood-Typing on T-Chips. This model for population scale Blood-Typing will be the development focus in this Phase II: thereby enabling, we propose, an entirely new vision for population-scale blood banking & transfusion medicine, and in the process, will allow Blood- Typing to return, in the 21st century, to prominence as the model and gold standard for the field of genetically personalized medicine: as it first did a hundred years ago. Based on that model for population-scale blood group genetic testing, we propose the following set of Phase II Aims. SA1. Complete & Validate the Multiplex PCR Front-end to the Transfusion-Chip, for DNA Samples. SA2. Complete & Validate the Multiplex PCR Front-end to the Transfusion-Chip, for Raw Samples. SA3. Optimize & validate fabrication of the Transfusion-Chip in the 48 array per slide "$1 microarray" format. SA4. Modify existing GenUSA analysis software, RicimerTM, for automated blood group typing. SA5. Validate the Transfusion-Chip for purified DNA, raw blood & raw OrageneTM-stabilized saliva samples. Phase II Deliverables & Commercialization Plan. Upon completion of this Phase II, we will have ready a Transfusion-Chip kit prototype (microarrays, PCR reagents, Hybridization Reagents, Specialized Software) for subsequent Beta Testing. This kit will be prepared under manufacturing control (ISO 13845) similar to the HLA-Chip products from GenUSA which are currently being launched into tissue compatibility and immunogenetics markets. Subsequent to completion of Phase II, GenUSA will launch the T-Chip into the RUO Blood-Typing market and prepare simultaneously for FDA 510(k) submission to enter into the diagnostics market either alone, or in partnership with those with a proven market presence in transfusion medicine or at-home sample collection, or both.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).