MORGAN AND MENDEL GENOMICS, INC.

www.morganandmendel.com

http://www.morganandmendel.com

770-656-6484

apaul@morganandmendel.com

ANDREW PAUL

P1908133

789T7

Active

Non-Manufacturer

2024-03-02

2028-12-12

2024-12-07

ANDREW M. PAUL

+1 770-656-6484

FA864922P1061

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AWARD

PURCHASE ORDER

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0.00

0.00

Department of Defense

2022-07-22

NOVEL, RAPID AND ACCURATE BLOOD TESTS FOR DETECTING HEREDITARY CANCER RISK

541715: RESEARCH AND DEVELOPMENT IN THE PHYSICAL, ENGINEERING, AND LIFE SCIENCES (EXCEPT NANOTECHNOLOGY AND BIOTECHNOLOGY)

AC32: NATIONAL DEFENSE R&D SERVICES; DEFENSE-RELATED ACTIVITIES; APPLIED RESEARCH

FA864922P0256

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AWARD

PURCHASE ORDER

49955.00

49955.00

49955.00

Department of Defense

2021-11-03

PRECISION GENOMICS FOR UNITED STATES AIR FORCE PERSONNEL USING CANCER RISK B AND CANCER RISK C

541715: RESEARCH AND DEVELOPMENT IN THE PHYSICAL, ENGINEERING, AND LIFE SCIENCES (EXCEPT NANOTECHNOLOGY AND BIOTECHNOLOGY)

AC32: NATIONAL DEFENSE R&D SERVICES; DEFENSE-RELATED ACTIVITIES; APPLIED RESEARCH

2022-08-16

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Department of Health and Human Services

ROBUST PREDICTOR OF COLON CANCER RISK - SUMMARY AT LEAST 500,000 PEOPLE IN THE UNITED STATES HAVE LYNCH SYNDROME (LS), BASED ON INHERITANCE OF A GENETIC PATHOGENIC VARIANT IN THE MISMATCH REPAIR (MMR) PATHWAY, PLACING THEM AT HIGH-RISK FOR COLON AND OTHER CANCERS. MORE THAN HALF OF THEM IS UNAWARE OF THEIR DIAGNOSIS, BECAUSE THEIR FAMILY HISTORY IS UNINFORMATIVE OR UNKNOWN. GENETIC TESTING IS IMPORTANT FOR IDENTIFYING PATHOGENIC VARIANTS IN THIS PATHWAY, BUT IN A LARGE NUMBER OF CASES NO PATHOGENIC VARIANT OR A VARIANT OF UNCERTAIN SIGNIFICANCE IS IDENTIFIED, LEADING TO AMBIGUOUS AND UNSATISFACTORY RESULTS. AS MORE PEOPLE ARE SEEKING TESTING FOR LS, ACCURATE ALTERNATIVES TO SEQUENCING ARE NEEDED TO PREDICT THE MOLECULAR PHENOTYPIC EFFECTS OF PATHOGENIC VARIANTS IN GENES IN THE MMR PATHWAY. RISK CLASSIFICATION SCORES BASED ON FLOW VARIANT ASSAYS (FVAS) ARE A NEW TECHNOLOGY THAT CAN ACCURATELY IDENTIFY PEOPLE WITH HETEROZYGOUS GERMLINE PATHOGENIC VARIANTS IN THESE PATHWAYS. IN RESPONSE TO TREATMENT WITH CHEMICAL AGENTS, FVAS IDENTIFY DECREASED NUCLEAR LOCALIZATION OF REPAIR PROTEINS AND DECREASED PHOSPHORYLATION OF DAMAGE-SENSING PROTEINS IN CELLS THAT BEAR PATHOGENIC VARIANTS IN THESE GENES. THE RESULTING TEST, CANCER RISK C (CR-C), IS RAPID, INEXPENSIVE AND HIGHLY REPRODUCIBLE AND CAN BE PERFORMED ON CIRCULATING AND CULTURED HUMAN BLOOD CELLS, THUS BECOMING A NEXT GENERATION, NON-SEQUENCING, STANDALONE TEST FOR DIAGNOSING LS. THE GOAL OF THIS STTR PROJECT IS TO DEVELOP A, SIMPLE, RAPID AND INEXPENSIVE CLINICAL TEST THAT WILL ACCURATELY DIAGNOSE LS AND CAN BE IMPLEMENTED INTO CLINICAL PRACTICE. AIM 1. PREDICT RISK OF DEVELOPING COLON CANCER BASED ON CR-C TEST RESULTS. AIM 2. PREVALENCE OF LS AMONG MICROSATELLITE INSTABILITY HIGH (MSI- H), MSI-LOW AND MSI-STABLE SUBJECTS WITH COLON CANCER. AIM 3. DEMONSTRATE ANALYTICAL VALIDITY AND REPRODUCIBILITY OF CR-C KITS FOR LS DIAGNOSIS AT 3 SITES. THIS PRODUCT WILL BE SOLD TO CLINICAL LABORATORIES IN COLLABORATION WITH A DESIGNATED GOOD MANUFACTURING PRACTICES FACILITY COMMERCIAL PARTNER, INITIALLY AS A LABORATORY DEVELOPED TEST AND THEN AS AN FDA APPROVED TEST. SEVERAL FACTORS WILL DRIVE THIS COMMERCIALIZATION INTO THE $1B MARKET CANCER RISK ASSESSMENT MARKET: 1. LOW ENTRY AND PERFORMANCE COSTS, 2. GREATER ACCURACY THAN SEQUENCING, AND 3. APPLICATION TO UNDERSTANDING RISKS FOR COLON, ENDOMETRIAL, GASTRIC, OVARIAN, SMALL BOWEL, PANCREATIC, URINARY TRACT, KIDNEY, BILE DUCT AND BRAIN CANCERS. THE CREATION OF SIMPLIFIED, COMMERCIAL CR-C KITS WILL CHANGE THE DIAGNOSIS OF LS.

1999992.00

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2020-12-10

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Department of Health and Human Services

ROBUST PREDICTOR OF COLON CANCER RISK - SUMMARY AT LEAST 500,000 PEOPLE IN THE UNITED STATES ARE AT HIGH-RISK FOR LYNCH SYNDROME, BASED ON INHERITANCE OF A GENETIC MUTATION IN THE MISMATCH REPAIR (MMR) OR DOUBLE STRAND BREAK (DSB) REPAIR PATHWAY. MORE THAN HALF OF THEM ARE UNAWARE OF THEIR RISK, BECAUSE THEIR FAMILY HISTORY IS UNINFORMATIVE OR UNKNOWN. GENETIC TESTING IS IMPORTANT FOR IDENTIFYING MUTATIONS IN THIS PATHWAY, BUT IN A LARGE NUMBER OF CASES NO MUTATION OR A VARIANT OF UNCERTAIN SIGNIFICANCE WILL BE IDENTIFIED, LEADING TO AMBIGUOUS, UNSATISFACTORY RESULTS. AS MORE PEOPLE ARE SEEKING TESTING TO IDENTIFY THEIR RISK OF LYNCH SYNDROME, ACCURATE ALTERNATIVES TO SEQUENCING ARE NEEDED TO PREDICT THE MOLECULAR PHENOTYPIC EFFECTS OF MUTATIONS IN GENES IN COLON CANCER AND ENDOMETRIAL CANCER- PREDISPOSING PATHWAYS. RISK CLASSIFICATION SCORES BASED ON FLOW VARIANT ASSAYS (FVAS) ARE A NEW TECHNOLOGY THAT CAN ACCURATELY IDENTIFY PEOPLE WITH HETEROZYGOUS GERMLINE MUTATIONS IN THESE PATHWAYS. IN RESPONSE TO TREATMENT WITH CHEMICAL AGENTS, FVAS IDENTIFY DECREASED NUCLEAR LOCALIZATION OF REPAIR PROTEINS AND DECREASED PHOSPHORYLATION OF DAMAGE-SENSING PROTEINS IN CELLS THAT BEAR MUTATIONS IN THESE GENES. FVAS ARE RAPID, INEXPENSIVE AND HIGHLY REPRODUCIBLE AND CAN BE PERFORMED ON CIRCULATING AND CULTURED HUMAN BLOOD CELLS, THUS LENDING THEMSELVES TO BECOMING A NEXT GENERATION, NON-SEQUENCING, STANDALONE TEST FOR ASSESSING CANCER RISKS. THE GOAL OF THIS STTR PROJECT IS TO DEVELOP A, SIMPLE, RAPID AND INEXPENSIVE CLINICAL TEST THAT WILL ACCURATELY IDENTIFY THOSE AT HIGH RISK FOR LYNCH SYNDROME. PHASE I HYPOTHESIS. THE STANDALONE FVA TEST USING WHOLE BLOOD SAMPLES WILL IDENTIFY THOSE AT HIGH-RISK WITH 95% ACCURACY. SPECIFIC AIM 1. ACHIEVE MMR PATHWAY RISK CLASSIFICATION SCORE FOR 99% OF SUBJECTS WITH AT LEAST 95% ACCURACY ON 180 SUBJECTS FROM WELL-CHARACTERIZED RISK GROUPS. SPECIFIC AIM 2. ACHIEVE RISK CLASSIFICATION SCORE RESULTS FOR ALL SUBJECTS FROM AIM 1 WITH COMPARABLE ACCURACY USING AN AUTOMATED GATING AND ANALYSIS PROTOCOL AND A NEWLY CREATED COMMERCIAL KIT. HAVING DEMONSTRATED ANALYTICAL VALIDITY IN PHASE I, MMG WILL DEMONSTRATE CLINICAL UTILITY IN PHASE II BY CALCULATING AND VALIDATING 10-YEAR HAZARD RATIOS FOR COLON CANCER BY AGE DECADE FOR 1,800 PEOPLE FOLLOWED BY UP TO 20 YEARS BY THE NCI’S COLON CANCER FAMILY REGISTRY. THIS PRODUCT WILL BE SOLD TO CLINICAL LABORATORIES IN COLLABORATION WITH A DESIGNATED GOOD MANUFACTURING PRACTICES FACILITY COMMERCIAL PARTNER, INITIALLY AS A LABORATORY DEVELOPED TEST AND THEN AS AN FDA APPROVED TEST. SEVERAL FACTORS WILL DRIVE THIS COMMERCIALIZATION INTO THE $1B MARKET CANCER RISK ASSESSMENT MARKET: 1. LOW ENTRY AND PERFORMANCE COSTS, 2. GREATER ACCURACY THAN SEQUENCING, AND 3. APPLICATION TO UNDERSTANDING RISKS FOR ENDOMETRIAL, GASTRIC, OVARIAN, SMALL BOWEL, PANCREATIC, URINARY TRACT, KIDNEY, BILE DUCT AND BRAIN CANCERS. THE CREATION OF SIMPLIFIED, COMMERCIAL FVA KITS WILL CHANGE RISK ASSESSMENT FOR LYNCH SYNDROME.

300000.00

0.00

0.00

2021-08-31

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Department of Health and Human Services

ROBUST PREDICTOR OF BREAST CANCER RISK - SUMMARY APPROXIMATELY 1.5 MILLION WOMEN IN THE UNITED STATES ARE AT HIGH-RISK FOR DEVELOPING BREAST CANCER, BASED ON INHERITANCE OF A GERMLINE MUTATION IN A GENE IN THE DOUBLE STRAND-BREAK (DSB) REPAIR AND CYCLIN-CHECKPOINT PATHWAYS. MANY ARE UNAWARE OF THEIR GENETIC PREDISPOSITIONS, BECAUSE THEIR FAMILY HISTORY IS UNINFORMATIVE OR UNKNOWN. GENETIC TESTING IS IMPORTANT FOR IDENTIFYING MUTATIONS IN THESE GENES, BUT IN ~80% OF CASES NO MUTATION IS IDENTIFIED, LEADING TO AMBIGUOUS, UNSATISFACTORY RESULTS. IDENTIFYING WOMEN AT HIGH RISK PRIOR TO THE ONSET OF DISEASE IS AN IMPORTANT CHALLENGE FOR PERSONALIZED MEDICINE, BECAUSE DISEASE CAN BE PREVENTED OR TREATED AT THE EARLIEST STAGE WHEN CURE IS MORE LIKELY. AS MORE WOMEN ARE SEEKING GENETIC TESTING TO IDENTIFY THEIR RISK OF BREAST CANCER, ACCURATE ALTERNATIVES TO SEQUENCING ARE NEEDED TO PREDICT THE MOLECULAR PHENOTYPIC EFFECTS OF MUTATIONS IN GENES IN BREAST CANCER-PREDISPOSING PATHWAYS. RISK CLASSIFICATION SCORES BASED ON FLOW VARIANT ASSAYS (FVAS) ARE A NEW TECHNOLOGY THAT CAN ACCURATELY IDENTIFY WOMEN WITH HETEROZYGOUS GERMLINE MUTATIONS IN THESE PATHWAYS. FVAS ARE RAPID, INEXPENSIVE AND HIGHLY REPRODUCIBLE AND CAN BE PERFORMED ON CIRCULATING AND CULTURED HUMAN BLOOD CELLS, THUS LENDING THEMSELVES TO BECOMING A NEXT GENERATION, NON- SEQUENCING, STANDALONE TEST. THE GOAL OF THIS STTR PROJECT IS TO DEVELOP A SIMPLE, RAPID AND INEXPENSIVE CLINICAL TEST THAT WILL ACCURATELY IDENTIFY THOSE AT HIGH RISK FOR BREAST CANCERS. PHASE I HYPOTHESIS: THE STANDALONE FVA TEST USING WHOLE BLOOD SAMPLES WILL IDENTIFY THOSE AT HIGH-RISK WITH 95% ACCURACY. SPECIFIC AIM 1. ACHIEVE RISK CLASSIFICATION SCORE RESULTS FOR 99% OF SUBJECTS WITH AT LEAST 95% ACCURACY ON 180 SUBJECTS FROM WELL-CHARACTERIZED RISK GROUPS. SPECIFIC AIM 2. ACHIEVE RISK CLASSIFICATION SCORE RESULTS FOR ALL SUBJECTS FROM AIM 1 WITH COMPARABLE ACCURACY USING AN AUTOMATED ANALYSIS PROTOCOL AND NEWLY CREATED COMMERCIAL KIT. HAVING DEMONSTRATED THE ANALYTICAL VALIDITY IN PHASE I, MMG WILL DEMONSTRATE CLINICAL UTILITY IN PHASE II BY CALCULATING AND VALIDATING 10-YEAR HAZARD RATIOS FOR BREAST CANCER BY AGE DECADE FOR 1,800 WOMEN FOLLOWED BY UP TO 20 YEARS BY THE NCI’S BREAST CANCER FAMILY REGISTRY. IN ADDITION, MMG WILL DEMONSTRATE THE ANALYTICAL VALIDITY OF THIS TEST ANALYTICAL VALIDITY AND REPRODUCIBILITY OF FVA TEST KITS IN-HOUSE AND AT COLLABORATING LABORATORIES, DEMONSTRATE THE ROLES OF MUTATIONS IN HIGH AND MODERATE-PENETRANCE DSB REPAIR GENES IN MODIFYING FVA TRAITS, AND DEMONSTRATE THE STABILITY OF FVA TRAITS OVER TIME AND WHETHER THESE ARE AFFECTED BY EXPOSURE TO CHEMOTHERAPY. THIS PRODUCT WILL BE SOLD TO CLINICAL LABORATORIES IN COLLABORATION WITH A DESIGNATED GOOD MANUFACTURING PRACTICES FACILITY COMMERCIAL PARTNER AS AN FDA APPROVED TEST. SEVERAL FACTORS WILL DRIVE THIS COMMERCIALIZATION INTO THE $1B MARKET CANCER RISK ASSESSMENT MARKET: 1. LOW ENTRY AND PERFORMANCE COSTS, 2. GREATER ACCURACY THAN SEQUENCING, 3. APPLICATION TO UNDERSTANDING RISKS FOR OVARIAN, PANCREATIC AND PROSTATE CANCERS, AND 4. COMPANION DIAGNOSTIC FOR THE NEW CLASS OF TARGETED CHEMOTHERAPY, CALLED “PARP INHIBITORS.” THE CREATION OF SIMPLIFIED, COMMERCIAL FVA KITS WILL BE A GAME CHANGER FOR ASSESSING CANCER RISKS.

2158832.89

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