SPECIFICITY, INC.

IGF::OT::IGF DIVISION: CHEMICAL&BIOLOGICAL PPA: CBRNE DEFENSE R&D PROGRAM: BIOAGENT THREAT ASSESSMENT PROJECT: RAPID BIODETECTION PERFORMER: TBD APPROPRIATION YEAR: FY12 (24 FUNDS) BUDGET AUTHORITY: THREE YEAR R&D FUNDS PROJECT MANAGER: DAVID HODGE, 202-254-5813 LEAD SUPPORT STAFF: JASON RAMAGE, 202-254-6799 ALC: 70-08-1513 TAS: 70240800 DESCRIPTION: THE PURPOSE OF THIS REQUISITION IS TO EARMARK $1,800,000.00 FOR THE DEVELOPMENT OF NOVEL RAPID ANTHRAX DIAGNOSTIC TEST WITH HIGH SPECIFICITY AND SENSITIVITY FOR THE RAPID BAIODETECTION PROGRAM WITHIN THE DEPARTMENT OF HOMELAND SECURITY SCIENCE AND TECHNOLOGY (S&T) CHEMICAL AND BIOLOGICAL DIVISION. THE TOTAL ESTIMATED FUNDS OF THIS CONTRACT ARE $2,000,000.00. TOTAL OBLIGATED FUNDS OF THIS CONTRACT ARE $1,800,000. THE PERIOD OF PERFORMANCE IS 24 MONTHS FROM THE DATE OF CONTRACT AWARD. THE DHS TECHNICAL POINT OF CONTACT IS AS FOLLOWS: DAVID HODGE DEPARTMENT OF HOMELAND SECURITY SCIENCE AND TECHNOLOGY DIRECTORATE WASHINGTON, DC 20528 PHONE: 202.254.5813 E-MAIL: DAVID.HODGE@HQ.DHS.GOV

INTERNATIONAL CLASSIFICATION OF DISEASES, 10TH EDITION, CLINICAL MODIFICATION (ICD-10) REPLACES THE CURRENT INTERNATIONAL CLASSIFICATION OF DISEASES, 9TH EDITION, CLINICAL MODIFICATION (ICD-9) CLASSIFICATION SYSTEM TO PROVIDE INCREASED SPECIFICITY AND DETAIL IN DIAGNOSIS AND PROCEDURAL RECORDING AND REPORTING. ALL HEALTH CARE ORGANIZATIONS MUST BE READY TO UTILIZE ICD-10 CODES ON OCTOBER 1, 2013, IN ORDER TO MAINTAIN CLINICAL DATA COMPARABILITY AND BILLING OF SERVICES. THIS PROJECT WILL REMEDIATE APPROXIMATELY 1,026 CLASS 3 ROUTINES AND APPLICATIONS THAT ARE DEEMED TO REMAIN IN USE AFTER THE OCTOBER 2013 DEADLINE. THIS PROJECT IS DESIGNED TO IMPLEMENT THE TRANSITION OF CLASS III ROUTINES AND APPLICATIONS FROM ICD-9 TO ICD-10.

SBIR PHASE II AWARD - DETECTION OF ACTIVE BIOLOGICAL TOXINS BY EXPLOITING NATIVE BINDING SPECIFICITIES

THE PURPOSE OF THIS TOPIC IS TO DEVELOP TECHNOLOGIES TO CHARACTERIZE GLYCAN MOIETIES OF GLYCOPROTEINS TO ENHANCE THE DIAGNOSTIC CAPABILITY OF PROTEIN-BASED BIOMARKERS. THE SPECIFIC GOALS OF THE PHASE II PROJECT ARE TO: 1) EXPAND THE NUMBER OF FEATURES ABOVE 54 FOR THE EXISTING V7 SIALIC ACID GLYCAN ARRAY AND PERFORM PRELIMINARY VALIDATION WITH SMALL NUMBERS OF SERUM SAMPLES, 2) OPTIMIZE THE SERUM ASSAY PROTOCOL FOR THE LARGER SIALIC ACID GLYCAN ARRAY AND ASSAY SPECIFICITY AND SENSITIVITY WILL BE MORE THOROUGHLY CHARACTERIZED, 3) EVALUATE METHODS FOR SCALE-UP OF PRODUCTION OF THE LARGER SIALIC ACID GLYCAN ARRAYS, AND 4) COLLABORATE WITH INVESTIGATORS IN NCI'S EARLY DETECTION RESEARCH NETWORK TO VALIDATE CLINICALLY, AND WITH STATISTICAL SIGNIFICANCE, THE LARGER SIALIC ACID GLYCAN ARRAY DEVELOPED IN THIS PROJECT. THE ULTIMATE GOAL WILL BE TO IDENTIFY AND VALIDATE AN ACTUAL "HIT" (PARTICULAR ANTIBODY OR PATTERN OF ANTIBODIES THAT IS PREDICTIVE OF CANCER RISK AND/OR PROGNOSIS), THAT CAN SUBSEQUENTLY BE COMMERCIALIZED.

HYDRAZINE, A VOLATILE AND FLAMMABLE COLORLESS LIQUID, IS CLASSIFIED AS A CARCINOGEN BY THE US ENVIRONMENTAL PROTECTION AGENCY. IT CAN CAUSE CHROMOSOME ABERRATIONS NEGATIVELY AFFECTING THE LUNGS, LIVER, SPLEEN, THYROID GLAND, AND CENTRAL NERVOUS SYSTEM. NASA S EXISTING HYDRAZINE MEASUREMENT TECHNOLOGY IS SENSITIVE, SELECTIVE AND RELIABLE, BUT IT TAKES 15 MINUTES TO COLLECT AND ANALYZE A SAMPLE. FOR FUTURE MISSIONS BEYOND LOW EARTH ORBIT, NASA WILL NEED A MEASUREMENT SYSTEM THAT RESPONDS WITHIN 30 SECONDS WITHOUT ANY PERFORMANCE LIMITATIONS SUCH AS LACK OF SPECIFICITY AND MAINTENANCE CHALLENGES. TO FULFILL NASA NEEDS, INNOSENSE LLC (ISL) WILL CONTINUE DEVELOPING A SPACE-WORTHY MICRO-ELECTROANALYTICAL SENSOR FOR RAPID MONITORING OF HYDRAZINE (MICRO-ZIN ) IN THE PRESENCE OF AMMONIA IN SPACECRAFT CABIN ATMOSPHERE (SCA) FOR LONG-TERM PERFORMANCE WITHOUT MAINTENANCE. IN PHASE I, ISL DEVELOPED A COMPACT MICRO-ZIN WORKING MODEL AND DEMONSTRATED ITS PERFORMANCE DETECTING HYDRAZINE WITH HIGH SENSITIVITY AND SELECTIVITY OVER AMMONIA, FAST RESPONSE TIME (T90>30 SECONDS), REVERSIBILITY, CYCLABILITY AND REPRODUCIBILITY UNDER NASA-REQUIRED SCA CONDITIONS, MEETING OR EXCEEDING PERFORMANCE TARGETS. IN PHASE II, ISL WILL FOCUS ON OPTIMIZATION AND SCALE-UP OF MICRO-ZIN FOLLOWING FINE-TUNING OF PERFORMANCE AND ANALYZING LIFE EXPECTANCY BY RIGOROUS TESTING. COMPLEX MODELING, PACKAGE DESIGN, AND CONSTRUCTION OF A MICRO-ZIN PROTOTYPE FOR SCA-LEVEL TESTING ARE ALSO PLANNED. AT THE END OF PHASE II, A COMPACT, BATTERY-OPERATED, HANDHELD MICRO-ZIN PROTOTYPE WILL BE DELIVERED TO NASA FOR FURTHER EVALUATION.

IGF::OT::IGF OTHER FUNCTION - DEVELOPMENT OF A SENSOR TO DETECT SELECT TRACE TOXIC HEAVY METALS (AG, CD, MN, NI, AND ZN) IN WATER IS PROPOSED. USING AN AUTOMATIC SIDE-STREAM SAMPLING TECHNIQUE, THIS COMPACT, ELECTROCHEMICAL SENSOR WILL USE SMALL VOLUMES OF WATER AND DETECT METALS IN THE LOW PARTS-PER-BILLION RANGE. THE NOVEL COUPLING OF A HIGH-PERFORMANCE NOVEL ELECTRODE MATERIAL, MICROARRAY ELECTRODE GEOMETRY, AND A HIGHLY SENSITIVE SENSING ALGORITHM ALLOWS FOR A SENSOR WITH LOW DETECTION LIMITS AND EXCELLENT SPECIFICITY. ADDITIONALLY, THE SENSOR WILL SHOW LONG-TERM REPEATABILITY AND RELIABILITY, WHILE REQUIRING MINIMAL MAINTENANCE OR USER CALIBRATION TIME. THE SENSOR AND ITS COMPONENTS HAVE BEEN ENGINEERED TO FUNCTION IN A MICROGRAVITY ENVIRONMENT AND FOR EASY INTEGRATION WITH THE WATER RECOVERY SYSTEM. GINER WILL PARTNER JOHNSON SPACE CENTER TO ENSURE THE ABILITY OF THE SENSOR TO DETECT TRACE METALS IN A RANGE OF RECLAIMED WATER SAMPLES AND DETERMINE THE APPROPRIATE CONCENTRATIONS. THIS SENSOR WILL DETECT TRACE HEAVY METALS IN WATER IN NEAR REAL-TIME, ALLOWING FOR TIMELY RESPONSE AND RESOLUTION TO WATER CONTAMINATION PROBLEMS.

AURORA FLIGHT SCIENCES CORPORATION AND PARTNER, DRAPER LABORATORY, PROPOSE TO DEVELOP AN ON-ORBIT IMMUNO-BASED LABEL-FREE WHITE BLOOD CELL COUNTING SYSTEM USING MEMS TECHNOLOGY (OILWBCS-MEMS) FOR HUMAN SPACEFLIGHT EXPERIMENTAL AND MEDICAL MONITORING PRACTICES. OUR PROPOSED SYSTEM IS DESIGNED TO MEET NASA'S REQUIREMENTS FOR A MICROGRAVITY COMPATIBLE, MINIATURIZED, LIGHT WEIGHT PERIPHERAL BLOOD CELL COUNTING INSTRUMENT CAPABLE OF ON-ORBIT CELL COUNTING, WITHOUT HIGH ENERGY LASERS, REQUIRING MINIMAL SAMPLE VOLUME OR EXOGENOUS (SHEATH) FLUID, AND GENERATING MINIMAL BIO-HAZARDOUS WASTE: SBIR TOPIC X14.02 "ON ORBIT CELL COUNTING AND ANALYSIS CAPABILITY". THE PROPOSED DETECTION TECHNOLOGY LEVERAGES CHANGES IN OPTICAL TRANSMISSION THROUGH A SURFACE DUE TO MOLECULAR BINDING (E.G., ANTIBODY-ANTIGEN BINDING). ANTIBODIES SPECIFIC TO THE WHITE BLOOD CELL SURFACE PROTEIN MARKERS (ANTIGENS) ARE PRE-COATED ON THE SENSOR SURFACE TO RECOGNIZE SPECIFIC WHITE BLOOD CELL TYPES WITH INHERENTLY HIGH SPECIFICITY AND SENSITIVITY. IN PHASE I WE DEVELOPED SURFACE CHEMISTRY AND DEMONSTRATED SURFACE CHEMISTRY SENSITIVITY AND SPECIFICITY FOR TOTAL WHITE BLOOD CELLS AND TWO LYMPHOCYTE SUBTYPES (B-CELLS, CD4+ T-CELLS). DURING PHASE II WE WILL DEVELOP A FUNCTIONAL PROTOTYPE OF THE OILWBCS-MEMS DEVICE TO DEMONSTRATE THAT END-TO-END OPERATIONS FROM SAMPLE-IN TO SIGNAL-OUT PRODUCES CLINICALLY RELEVANT RESULTS. THE OILWBCS-MEMS DESIGN WILL INCLUDE SINGLE-USE REPLACEABLE CARTRIDGES FOR FLUID LOOP AND SENSOR COMPONENTS.

HIGH INTERACTIVITY VISUALIZATION SOFTWARE FOR LARGE COMPUTATIONAL DATA SETS EXISTING SCIENTIFIC VISUALIZATION TOOLS HAVE SPECIFIC LIMITATIONS FOR LARGE SCALE SCIENTIFIC DATA SETS. OF THESE FOUR LIMITATIONS CAN BE SEEN AS PARAMOUNT: (I) MEMORY MANAGEMENT, (II) REMOTE VISUALIZATION, (III) INTERACTIVITY, AND (IV) SPECIFICITY. IN PHASE I, WE PROPOSED AND SUCCESSFULLY DEVELOPED A PROTOTYPE OF A COLLECTION OF COMPUTER TOOLS AND LIBRARIES CALLED SCIVIZ THAT OVERCOME THESE LIMITATIONS AND ENABLE RESEARCHERS TO VISUALIZE LARGE SCALE DATA SETS (GREATER THAN 200 GIGABYTES) ON HPC RESOURCES REMOTELY FROM THEIR WORKSTATIONS AT INTERACTIVE RATES. A KEY ELEMENT OF OUR TECHNOLOGY IS THE STACK ORIENTED RATHER THAN A FRAMEWORK DRIVEN APPROACH WHICH ALLOWS IT TO INTEROPERATE WITH COMMON EXISTING SCIENTIFIC VISUALIZATION SOFTWARE THEREBY ELIMINATING THE NEED FOR THE USER TO SWITCH AND LEARN NEW SOFTWARE. THE RESULT IS A VERSATILE 3D VISUALIZATION CAPABILITY THAT WILL SIGNIFICANTLY DECREASE THE TIME TO KNOWLEDGE DISCOVERY FROM LARGE, COMPLEX DATA SETS.

IN THIS SBIR EFFORT, WE PROPOSE TO DEVELOP, TEST AND DEPLOY THREE NOVEL COMPACT, RUGGED AND EASY-TO-USE MULTI-GAS ANALYSIS INSTRUMENTS, BASED ON TUNABLE DIODE LASER ABSORPTION SPECTROMETRY AND A PATENTED CAVITY-ENHANCED LASER ABSORPTION-BASED STRATEGY CALLED OFF-AXIS INTEGRATED CAVITY OUTPUT SPECTROSCOPY (OFF-AXIS ICOS), FOR MONITORING AND CONTROL OF EXTRAPLANETARY REGOLITH PROCESSING AND OXYGEN PRODUCTION. THE INSTRUMENTS WILL ALSO PROVE USEFUL FOR IN SITU SURFACE ANALYSIS. THE FIRST INSTRUMENT (INSTRUMENT #1), BASED ON FAST EXTRACTIVE SAMPLING, WILL RECORD MEASUREMENTS OF SEVERAL IMPORTANT GAS-PHASE CONSTITUENTS IN REGOLITH PROCESSING FACILITIES WITH EXTRAORDINARILY HIGH SENSITIVITY, ACCURACY AND SPECIFICITY IN REAL TIME. THIS INSTRUMENT WILL INTEGRATE DIRECTLY INTO HYDROGEN AND CARBOTHERMAL REDUCTION TEST FACILITIES AT MAUNA KEA, HAWAII. THE MEASUREMENT QUANTITIES OF INTEREST INCLUDE THE CONCENTRATIONS OF HF, HCL, H2S, O2, H2, CH4, CO, CO2, H2O, AND H2O ISOTOPES (H2HO OR HDO AND H218O). THE SECOND INSTRUMENT (INSTRUMENT #2) WILL PROVIDE MEASUREMENTS OF H2O CONCENTRATIONS AND GAS TEMPERATURE DIRECTLY IN THE HIGH TEMPERATURE REACTIVE FLOW AND PRIOR TO HYDROLYSIS. THE THIRD INSTRUMENT (INSTRUMENT #3) WILL PROVIDE ACCURATE QUANTIFICATION OF THE AFOREMENTIONED GASES IN A COMPACT, LOW-POWER FORM FACTOR SUITABLE FOR INTEGRATION INTO THE REGOLITH AND ENVIRONMENT SCIENCE AND OXYGEN AND LUNAR VOLATILE EXTRACTION (RESOLVE) PROJECT

THIS PROPOSAL ADDRESSES THE NEED FOR MINIATURE, NARROW-LINEWIDTH, DEEP UV OPTICAL SOURCES THAT OPERATE AT VERY LOW AMBIENT TEMPERATURES FOR USE IN ADVANCED IN SITU PLANETARY SCIENCE INSTRUMENTS FOR NON-CONTACT DETECTION AND CLASSIFICATION OF TRACE AMOUNTS OF ORGANIC, INORGANIC, AND BIOGENIC MATERIALS USING RAMAN AND NATIVE FLUORESCENCE SPECTROSCOPIC METHODS. THE SOURCES INCLUDE ALUMINUM GALLIUM NITRIDE SEMICONDUCTOR LASERS AND ULTRA-NARROW-LINEWIDTH TRANSVERSE EXCITED HOLLOW CATHODE LASERS EMITTING BETWEEN 210 NM TO 250 NM, A SPECTRAL RANGE WITH DEMONSTRATED HIGHER DETECTION SENSITIVITY AND SPECIFICITY THAN SOURCES EMITTING AT LONGER WAVELENGTHS. APPLICATIONS INCLUDE NON-CONTACT ROBOT-ARM OR BODY MOUNTED CHEMICAL IMAGING INSTRUMENTS AND DETECTORS FOR DIRECT ANALYSIS OF TRACE LEVELS OF CHEMICAL SPECIES CONTAINING C, N, H, O, S, CL, ON SURFACES OR AS EXTRACTIONS FROM SOIL, ROCK, OR ICE. WE HAVE ACHIEVED THE HIGHEST RECORDED DEEP UV SEMICONDUCTOR INTERNAL QUANTUM EFFICIENCIES AT WAVELENGTHS BELOW 250 NM. BUT CONTINUING DIFFICULTIES OF ATTAINING LASER EMISSION AND PROSPECTS FOR NARROW LINE-WIDTH COMPATIBLE WITH RAMAN APPLICATIONS HAS CAUSED US TO REDIRECT A SIGNIFICANT PORTION OF THE PHASE II EFFORT TO ANOTHER CLASS OF DEEP UV LASER WITH A MORE PROVEN UV RAMAN TRACK RECORD AND THE POTENTIAL FOR MINIATURIZATION FOR ROBOT-ARM-MOUNTED APPLICATIONS.