Lydia Inc

METHYLSCAN FOR EARLY DETECTION OF LIVER AND LUNG CANCER - PROJECT SUMMARY THE LONG-TERM GOAL OF THIS SBIR PHASE II PROJECT IS TO DEVELOP AND MARKET A COMMERCIALLY VIABLE, BLOOD-BASED METHYLATION PROFILING TEST THAT CAN DETECT AND LOCATE MULTIPLE TYPES OF CANCER EARLY. CLINICAL INTERVENTION IN THE EARLY STAGES OF CANCER CAN GREATLY IMPROVE THE SURVIVAL OF CANCER PATIENTS. DESPITE THE TREMENDOUS DEMAND FOR EARLY DETECTION METHODS IN CLINICAL PRACTICE, FEW COMMERCIAL TESTS EXIST IN THE MARKET. TO ADDRESS THIS UNMET NEED, IN PHASE I, WE DEVELOPED AND VALIDATED A CELL-FREE DNA REDUCED REPRESENTATION BISULFITE SEQUENCING ASSAY, METHYLSCAN ASSAY, TO INTERROGATE THE METHYLATION PROFILE OF CFDNA. THE METHYLSCAN ASSAY WAS HIGHLY REPRODUCIBLE AND RELIABLE AT LOW INPUT QUANTITIES OF DNA AND ACHIEVED HIGH SENSITIVITY AND SPECIFICITY FOR DETECTING LIVER CANCER. DNA METHYLATION IS ESTABLISHED DURING EARLY MAMMALIAN CELL DIFFERENTIATION AND PLAYS AN IMPORTANT ROLE IN THE DEVELOPMENT AND PROGRESSION OF CANCER; THUS, IT IS AN IDEAL BIOMARKER NOT ONLY FOR PAN-CANCER DETECTION BUT ALSO FOR IDENTIFICATION OF TUMOR TISSUE OF ORIGIN. THE PROPOSED PROJECT WILL TRANSLATE THE METHYLSCAN ASSAY TO A SURVEILLANCE PRODUCT FOR LIVER CANCER AND EXPAND ITS INTENDED USE FOR EARLY LUNG CANCER DETECTION IN PATIENTS WITH INDETERMINATE LUNG NODULES. IN THIS PHASE II STUDY, OUR SPECIFIC AIMS ARE AS FOLLOWS: AIM 1) OPTIMIZE METHYLSCAN ASSAY AND THE WORKFLOW OF METHYLSCAN TEST; AIM 2) PERFORM A CLINICAL VALIDATION TO EVALUATE METHYLSCAN TEST FOR EARLY DETECTION OF HCC; AIM 3) PERFORM A CLINICAL VALIDATION TO EVALUATE METHYLSCAN TEST FOR EARLY DETECTION OF LUNG CANCER IN PATIENTS WITH INDETERMINATE LUNG NODULES. THE METHYLSCAN TEST WILL BE USED TO PERFORM CANCER PREDICTION IN A COHORT OF 200 EARLY HCC PATIENTS, 70 EARLY LUNG CANCER PATIENTS WITH MALIGNANT LUNG NODULES, 200 PATIENTS AT HIGH RISK FOR HCC OR 50 PATIENTS WITH BENIGN LUNG NODULES. PARTICIPANTS IN THE CLINICAL VALIDATION STUDY WILL BE RECRUITED FROM MIDWEST AND WEST COAST SITES. THE OUTCOME OF THIS PROJECT WILL SUPPORT LARGE CLINICAL TRIALS FOR METHYLSCAN TEST AS A SURVEILLANCE APPROACH FOR PATIENTS AT RISK OF LIVER AND LUNG CANCER. THE DATA COLLECTED WILL BE DISCUSSED WITH FDA IN A PRE-SUBMISSION MEETING.

COMMUNITY-BASED ABSTINENCE EDUCATION PROGRAM

TRANSITIONAL HOUSING SUPPORT AND FOLLOW UP SERVICES FOR VICTIMS OF DOMESTIC VIOLENCE

TRANSITIONAL HOUSING, SUPPORT AND FOLLOW-UP SERVICES FOR VICTIMS OF DOMESTIC VIOLENCE

AN ACCURATE, NON-INVASIVE, AND COST-EFFECTIVE METHYLOME TEST FOR EARLY CANCER DETECTION

SBIR PHASE I: HIGH-EFFICIENCY, ELECTRIFIED REVERSE-WATER GAS SHIFT FOR SUSTAINABLE FUELS PRODUCTION -THE BROADER IMPACT/COMMERCIAL POTENTIAL OF THIS SMALL BUSINESS INNOVATION RESEARCH (SBIR) PHASE I PROJECT WILL BE TO DIRECTLY AND IMMEDIATELY LOWER THE LONG-TERM COSTS OF E-FUELS (ELECTROFUELS), OR FUELS DERIVED FROM ELECTRICITY, CARBON DIOXIDE AND HYDROGEN. THE E-FUELS PRODUCED BY THE PROCESS REPRESENT AN IMPORTANT ALTERNATIVE FOR FOSSIL FUELS IN AVIATION, SHIPPING, AND OTHER AREAS OF TRANSPORTATION THAT ARE CHALLENGING TO ELECTRIFY. THE SOCIETAL IMPACT OF THE SYSTEM WOULD ALLOW LOW-CARBON OR EVEN CARBON-NEUTRAL, DROP-IN REPLACEMENT E-FUELS FOR FOSSIL FUELS. APPLIED AT SCALE TO THE AVIATION SECTOR, THIS TECHNOLOGY COULD ENABLE REDUCTION OF GREENHOUSE GAS EMISSIONS OF ROUGHLY 1 GIGATON (GT) ANNUALLY. EXTENDING E-FUELS USAGE INTO ADDITIONAL SECTORS SUCH AS SHIPPING AND LONG-HAUL GROUND TRANSPORTATION COULD ENABLE UP TO 3-5 GT ANNUAL REDUCTIONS IN EMISSIONS. COMMERCIALLY, THE E-FUELS DEVELOPED IN THIS PROJECT COULD PROVIDE A VIABLE ALTERNATIVE FOR A MULTI-TRILLION-DOLLAR MARKET FOR FOSSIL FUELS IN THESE SECTORS IF THEY CAN BE MADE COST EFFECTIVELY. THE RESEARCH WOULD DEMONSTRATE A SOLUTION THAT CAN ACHIEVE SUBSTANTIALLY LOWER CAPITAL COSTS AND OPERATING COSTS OF PRODUCING E-FUELS. THIS SBIR PHASE I PROJECT BUILDS AND DEMONSTRATES A BENCH-SCALE REACTOR FOR A HIGH-TEMPERATURE REVERSE WATER-GAS SHIFT (RWGS) PROCESS WITH ELECTRICITY AS THE ONLY ENERGY SOURCE. DESPITE ITS POTENTIAL TO MITIGATE EMISSIONS, THE RWGS REACTION HAS NOT BEEN WIDELY DEPLOYED DUE TO THE HIGH TEMPERATURES REQUIRED AND THE DIFFICULTY IN ACHIEVING UNIFORMITY WITHIN CONVENTIONAL CHEMICAL REACTORS. THE MICRO-STRUCTURED MATERIALS PRESENTED IN THE PROJECT HAVE SHOWN UNPRECEDENTED REACTION RATES AND PROCESS INTENSITY IN INITIAL EXPERIMENTS AT THE LAB-SCALE. THE RESEARCH WILL FOCUS ON IMPROVING THESE MATERIALS, AND THEIR DURABILITY AND INCORPORATING THEM INTO AN INTEGRATED REACTOR SYSTEM. THE TECHNICAL PROJECT WILL INCLUDE: (1) DEVELOPING A MULTI-SCALE MODEL OF THE REACTOR TO OPTIMIZE THE GEOMETRY OF THE REACTOR MATERIALS; (2) PROTOTYPING AND FABRICATING THE OPTIMIZED REACTOR MATERIALS; (3) MODIFYING THE MICRO-STRUCTURED MATERIALS WITH COATINGS AND ACTIVE METALS AS NEEDED; AND (4) TESTING OF THE REACTOR SYSTEM TO OPTIMIZE THE REACTION. AT THE END OF THE PROJECT, THE SYSTEM WILL BE READY FOR INTEGRATION INTO A LARGER PILOT-SCALE SYSTEM THAT SHOULD UNLOCK UNPRECEDENTED COST REDUCTIONS FOR CARBON DIOXIDE AND HYDROGEN DERIVED PRODUCTS AND BROADER APPLICATIONS WITHIN GREEN CHEMISTRY. THIS AWARD REFLECTS NSF'S STATUTORY MISSION AND HAS BEEN DEEMED WORTHY OF SUPPORT THROUGH EVALUATION USING THE FOUNDATION'S INTELLECTUAL MERIT AND BROADER IMPACTS REVIEW CRITERIA.- SUBAWARDS ARE NOT PLANNED FOR THIS AWARD.

PURPOSE: THE PURPOSE OF HUD’S COMPREHENSIVE HOUSING COUNSELING (CHC) GRANT IS TO PROVIDE DIRECT FUNDING SUPPORT TO HUD’S NATION-WIDE NETWORK OF APPROVED HOUSING COUNSELING AGENCIES. FOR MORE INFORMATION ABOUT THE COMPREHENSIVE HOUSING COUNSELING GRANT PROGRAM, SEE HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/HOUSING/SFH/HCC.; ACTIVITIES TO BE PERFORMED: HOUSING COUNSELING ACTIVITIES INCLUDE PROVIDING INFORMATION, ADVICE, AND TOOLS FOR CONSUMERS SEEKING, FINANCING, MAINTAINING, RENTING, OR OWNING A HOME. AGENCIES ALSO ASSIST THOSE FACING HOMELESSNESS AND HOMEOWNERS IN NEED OF FORECLOSURE ASSISTANCE. THE HOUSING COUNSELING ACTIVITY TYPES THAT CAN BE REIMBURSED BY THE CHC GRANT INCLUDE ALL APPROVED HOUSING COUNSELING, EDUCATION, AND OUTREACH TOPICS LISTED IN THE CURRENT. HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/ADMINISTRATION/HUDCLIPS/HANDBOOKS/HSGH/7610.1. THIS INCLUDES, BUT IS NOT LIMITED TO, PRE-PURCHASE/HOME BUYING COUNSELING, RESOLVING, OR PREVENTING FORWARD OR REVERSE MORTGAGE DELINQUENCY OR DEFAULT COUNSELING, AND NON-DELINQUENCY POST-PURCHASE COUNSELING. GRANTEES ARE REQUIRED TO DEMONSTRATE, THROUGH THE CURRENT FORM HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/ADMINISTRATION/HUDCLIPS/FORMS/HUD9, HOUSING COUNSELING AGENCY ACTIVITY REPORT, THE NUMBER OF HOUSEHOLDS THAT WERE COUNSELED BY ACTIVITY TYPE AND NUMBER OF HOUSEHOLDS THAT ATTENDED WORKSHOPS BY ACTIVITY TYPE DURING THE APPLICABLE FISCAL YEAR. HOUSING COUNSELING AGENCIES MAY ALSO BE SPECIFICALLY AWARDED TO PARTNER WITH A MINORITY-SERVING INSTITUTION (MSI) TO PROVIDE HOUSING COUNSELING TO THE MSI INSTITUTIONS’ COMMUNITIES AND EXPAND THESE INSTITUTIONS’ PARTNERSHIPS WITH HOUSING COUNSELING AGENCIES. OUTPUTS AND DELIVERABLES FOR THIS GRANT AWARD IS THE SAME AS THE PARAGRAPH DESCRIBED ABOVE, HOWEVER, GRANTEES ARE REQUIRED TO PARTNER WITH A MSI TO PROVIDE THOSE ACTIVITIES. ; EXPECTED OUTCOMES: THE QUANTIFIABLE OUTCOMES FOR THE CHC GRANT INCLUDE, BUT ARE NOT LIMITED TO, THE NUMBER OF HOUSEHOLDS THAT GAINED ACCESS TO HOUSING RESOURCES; RECEIVED INFORMATION ON FAIR HOUSING, FAIR LENDING, AND/OR ACCESSIBILITY RIGHTS; IMPROVED CURRENT LIVING CONDITIONS; PURCHASED HOUSING; RECEIVED A REVERSE MORTGAGE; PREVENTED OR RESOLVED A MORTGAGE DEFAULT; AND RECEIVED A LOAN MODIFICATION. ALL POSSIBLE OUTCOMES ARE LISTED IN SECTION 10 OF THE CURRENT FORM HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/ADMINISTRATION/HUDCLIPS/FORMS/HUD9, HOUSING COUNSELING AGENCY ACTIVITY REPORT.; INTENDED BENEFICIARIES: INDIVIDUALS, GROUPS OF INDIVIDUALS, AND FAMILIES WHO ARE RENTERS, TENANTS, HOMEOWNERS, AND HOME BUYERS UNDER HUD, CONVENTIONAL, AND OTHER GOVERNMENT PROGRAMS.; SUBRECIPIENT ACTIVITIES: THE SUBRECIPIENT ACTIVITIES ARE UNKNOWN AT THE TIME OF AWARD.

PURPOSE: THE PURPOSE OF HUD’S COMPREHENSIVE HOUSING COUNSELING (CHC) GRANT IS TO PROVIDE DIRECT FUNDING SUPPORT TO HUD’S NATION-WIDE NETWORK OF APPROVED HOUSING COUNSELING AGENCIES. FOR MORE INFORMATION ABOUT THE COMPREHENSIVE HOUSING COUNSELING GRANT PROGRAM, SEE HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/HOUSING/SFH/HCC.; ACTIVITIES TO BE PERFORMED: HOUSING COUNSELING ACTIVITIES INCLUDE PROVIDING INFORMATION, ADVICE, AND TOOLS FOR CONSUMERS SEEKING, FINANCING, MAINTAINING, RENTING, OR OWNING A HOME. AGENCIES ALSO ASSIST THOSE FACING HOMELESSNESS AND HOMEOWNERS IN NEED OF FORECLOSURE ASSISTANCE. THE HOUSING COUNSELING ACTIVITY TYPES THAT CAN BE REIMBURSED BY THE CHC GRANT INCLUDE ALL APPROVED HOUSING COUNSELING, EDUCATION, AND OUTREACH TOPICS LISTED IN THE CURRENT. HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/ADMINISTRATION/HUDCLIPS/HANDBOOKS/HSGH/7610.1. THIS INCLUDES, BUT IS NOT LIMITED TO, PRE-PURCHASE/HOME BUYING COUNSELING, RESOLVING, OR PREVENTING FORWARD OR REVERSE MORTGAGE DELINQUENCY OR DEFAULT COUNSELING, AND NON-DELINQUENCY POST-PURCHASE COUNSELING. GRANTEES ARE REQUIRED TO DEMONSTRATE, THROUGH THE CURRENT FORM HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/ADMINISTRATION/HUDCLIPS/FORMS/HUD9, HOUSING COUNSELING AGENCY ACTIVITY REPORT, THE NUMBER OF HOUSEHOLDS THAT WERE COUNSELED BY ACTIVITY TYPE AND NUMBER OF HOUSEHOLDS THAT ATTENDED WORKSHOPS BY ACTIVITY TYPE DURING THE APPLICABLE FISCAL YEAR. HOUSING COUNSELING AGENCIES MAY ALSO BE SPECIFICALLY AWARDED TO PARTNER WITH A MINORITY-SERVING INSTITUTION (MSI) TO PROVIDE HOUSING COUNSELING TO THE MSI INSTITUTIONS’ COMMUNITIES AND EXPAND THESE INSTITUTIONS’ PARTNERSHIPS WITH HOUSING COUNSELING AGENCIES. OUTPUTS AND DELIVERABLES FOR THIS GRANT AWARD IS THE SAME AS THE PARAGRAPH DESCRIBED ABOVE, HOWEVER, GRANTEES ARE REQUIRED TO PARTNER WITH A MSI TO PROVIDE THOSE ACTIVITIES. ; EXPECTED OUTCOMES: THE QUANTIFIABLE OUTCOMES FOR THE CHC GRANT INCLUDE, BUT ARE NOT LIMITED TO, THE NUMBER OF HOUSEHOLDS THAT GAINED ACCESS TO HOUSING RESOURCES; RECEIVED INFORMATION ON FAIR HOUSING, FAIR LENDING, AND/OR ACCESSIBILITY RIGHTS; IMPROVED CURRENT LIVING CONDITIONS; PURCHASED HOUSING; RECEIVED A REVERSE MORTGAGE; PREVENTED OR RESOLVED A MORTGAGE DEFAULT; AND RECEIVED A LOAN MODIFICATION. ALL POSSIBLE OUTCOMES ARE LISTED IN SECTION 10 OF THE CURRENT FORM HTTPS://WWW.HUD.GOV/PROGRAM_OFFICES/ADMINISTRATION/HUDCLIPS/FORMS/HUD9, HOUSING COUNSELING AGENCY ACTIVITY REPORT.; INTENDED BENEFICIARIES: INDIVIDUALS, GROUPS OF INDIVIDUALS, AND FAMILIES WHO ARE RENTERS, TENANTS, HOMEOWNERS, AND HOME BUYERS UNDER HUD, CONVENTIONAL, AND OTHER GOVERNMENT PROGRAMS.; SUBRECIPIENT ACTIVITIES: THE SUBRECIPIENT ACTIVITIES ARE UNKNOWN AT THE TIME OF AWARD.