sHLA Protein Chip

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44AI122642-03
Agency Tracking Number: R44AI122642
Amount: $1,000,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-02-01
Award End Date (Contract End Date): 2021-01-31
Small Business Information
2018 WESTVALLEY PL, Round Rock, TX, 78665-5011
DUNS: 141832860
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (847) 359-1032
Business Contact
Phone: (847) 359-1032
Research Institution
AbstractsHLA Protein ChipThe class IABCand class II HLA proteinsDRBDQDPcomprise the heart of the inducible human immune systemFor organmarrow and stem cell transplantationthe development of serum born antibodies against one or more of those many HLA proteins comprises the best and earliest test for transplant rejectionBecause of the enormous medical importance of transplantationserum testing for the appearance of anti HLA antibodies has emerged as one of the premier tests in all of laboratory medicineThe present $M yr market for HLA based transplantation serology is dominated by a single supplierThermo One Lambdawho has configured an anti HLA antibody screening test that is based on the use of membrane extracts coupled to Luminex beadsThat pairing of cell extracts and Luminex beads comprisesyear old technology whichalthough still the dominant market leaderis felt by Key Opinion Leaders in Transplantation Medicine to produce poor sensitivity and specificity relative to other kinds of serum immunoassayThere is thus a clear and present need for a new and better alternative to the current test method for anti HLA antibody screeningThe Phase IIb plan presented here provides a fundamentally new alternative to the dominant Thermo One Lambda testbased on the convergence of two highly innovative technology platformsICloning and expression of an enormously diverse family of recombinant HLA proteinsthe sHLAswhich was invented and developed by Pure Proteinclass Iclass IIIIDeployment of complex immunoassays such as those for thesHLAsin a simplelow cost protein microarray formatwhich was invented and developed by GMSbiotechThe commercial focus of the proposed Phase IIb planto be executed as a Pure ProteinGMS collaborationis to create a pair of microarray based testsEZScreenTM I andampEZScreenTM IIto be provided as a kit with all ancillary reagents and turn key analytical softwarewherein EzScreenTM I can interrogate in parallelas a single testserum antibodies againstdifferent recombinant class I sHLA proteinsand EZScreenTM II can interrogatealso in parallel as a single testserum antibodies againstdifferent recombinant class II sHLA proteinsEach EZScreenTM test is performed onuL of raw serum at room temperatureusing only simple laboratory pipettingby staff with no special expertise in bioinformaticsSpecific Aims of the Present Phase IIb StudySAComplete CloningExpression and Manufacture of the Remaining Class II sHLA ProteinsYrSAComplete Validation of EZScreenTM Manufacture at a Third Party OEM SupplierYrSAComplete EZScreenTM Analysis Software ValidationYrsSAEZScreenTM Kit ManufactureYrsSAEZScreenTM Beta Testing using ASHI Reference LabslabsProject NarrativesHLA Protein ChipA three year Phase IIB SBIR plan is proposedfocused on the development of a pair of microarray based tests for sera antibody detection which emerge against HLA proteinscomprising a fundamental improvement in the diagnostic side of Transplantation RejectionUpon completion of this planboth tests and the companion software will be ready for Research Use onlyRUOproduct launch and to begin the FDA review process

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

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