DIAGNOSTICS DEVELOPMENT

For over two decades, I have been advancing biotechnologies that are on the frontlines of numerous medical and public health interventions including highlighted applications in diagnostics and biosecurity.

PLATFORM AND NEW PRODUCT DEVELOPMENT

  • Current molecular tests ensuring safety of the US blood supply: HIV, HCV, HBV, West Nile virus
  • First combined Chlamydia and Gonorrhea molecular tests, eliminating need for male genital swabbing using male/female urine specimens
  • APTIMA Rapid Response Molecular Detection Platform translated from FDA cleared APTIMA CT/GC nucleic acid amplified tests (NAAT)
  • Biodefense and biothreat detection systems for US Intelligence Community
  • State-of-the-art DNA molecular vaccines, as well as, cell and gene therapies
  • HIV CD4 mobile testing interventions in Sub-Saharan Africa to ensure efficacy of HIV anti-retroviral therapies (ART) in rural low resource settings
  • Respiratory infectious disease diagnostic panels (Influenza, RSV, Tuberculosis)
  • Multiple infectious disease nucleic acid tests for Mycobacterium, Streptococcus, Staphylococcus, Campylobacter, and other pathogens
  • Alzheimer's disease microarray molecular diagnostic
  • Genomic-based protein splice variant molecular testing platform capability
  • Rapid prototyping chemistry platform for quantitation of biomarkers for oncology
MEDICAL DIAGNOSTICS DEVELOPMENT EXPERIENCE
DIAGNOSTICS CLEARED OR AUTHORIZED BY US FDA via BLA, 510(k) and EUA
US FDA CLEARED INFECTIOUS DISEASE DIAGNOSTICS (BLA and 510(k))

US FDA CLEARED CHRONIC DISEASE DIAGNOSTICS (LDT)

  • Developed and commercialized Alzheimer’s disease AclarusDx™ molecular diagnostic blood-based microarray laboratory developed test (LDT) for biomarker genomic expression profiling (Exonhit)

US FDA EMERGENCY USE AUTHORIZATIONS (EUAs) INFECTIOUS DISEASE DIAGNOSTICS
APTIMA® Rapid Response Detection Platform developed while at
Gen-Probe (circa 2004), platform later acquired by Hologic and deployed during public health emergencies in 2016 and 2020:
DIAGNOSTICS PLATFORM DEVELOPMENT
INFECTIOUS DISEASES
  • Integrated molecular and immunodiagnostic mobile biothreat detection systems for US intelligence community (Nanogen-Vectrant collaboration)
    • Demonstrated technical feasibility for point-of-care compact high-speed detection system using dual-function molecular and immunological diagnostic tests for biothreat detection of multiple clinical analytes (n > 15)
  • Influenza A/B rapid detection real-time PCR platform (Nanogen-Vectrant)
  • Influenza A/B rapid detection lateral flow immunodiagnostic platform (Nanogen-Vectrant)
  • Respiratory disease panels NanoChip® 400 molecular diagnostic array (Nanogen)
  • High-throughput and point-of-care (POC) systems for blood screening and infectious disease testing (Gen-Probe > Hologic, Nanogen)
    • Developed multiple diagnostic systems for sexually transmitted infections (STIs) and bloodborne, respiratory, and enteric pathogens, as well as laboratory information systems (LIS) for clinical and public health laboratories (Gen-Probe)
    • Developed infectious disease molecular diagnostics systems for multiple respiratory pathogens using automated robotic systems, nucleic acid microarray nanotechnologies and real-time PCR platforms (Nanogen)
    • Infectious disease rapid response detection platform via APTIMA® chemistry and instrumentation platform for high-throughput diagnostic testing (Gen-Probe > Hologic)
    • Specimen collection devices and proprietary target capture systems (Gen-Probe > Hologic, Nanogen, Vectrant, Intrexon)
    • Direct Tube Sampling (DTS) liquid handling system for APTIMA® & Procleix® product lines: proprietary penetrable caps on specimen collection tube to reduce cross contamination during testing workflow (Gen-Probe > Hologic)
  • Pilot Testing and Field-Hospital Laboratory integration for rolling out first-in-kind mobile HIV / CD4 testing capability to determine efficacy of HIV anti-retroviral therapies (ART) in low-resource setting rural communities in Sub-Saharan Africa (St. Gabriel’s Hospital - Malawi)

CHRONIC DISEASES
  • Research Use Only (RUO) rapid prototyping chemistry platform for quantitation of biomarkers for oncology (Intrexon)
  • SpliceArray™ genome-wide biomarker discovery platform for biomedical research (Exonhit)
  • Molecular diagnostic array for genomic-based Cystic Fibrosis diagnostics (Nanogen)
  • Research Use Only (RUO) Alzheimer’s disease complement binding assay (The Scripps Research Institute, Department of Immunology)

ADDITIONAL PROPHYLACTIC AND THERAPEUTIC MEDICAL COUNTERMEASURES
  • AdenoVerse™ DNA vaccine development platform for infectious diseases (Intrexon)
  • Infectious disease testing and vector control interventions for mosquito-borne diseases (Gen-Probe, St. Gabriel’s Hospital - Malawi, Intrexon)
  • Global health infectious and chronic disease interventions in Sub-Saharan Africa (St. Gabriel’s Hospital - Malawi)
DIAGNOSTICS CLEARED OR AUTHORIZED BY US FDA via BLA, 510(k) and EUA
US FDA CLEARED INFECTIOUS DISEASE DIAGNOSTICS (BLA and 510(k))

US FDA CLEARED CHRONIC DISEASE DIAGNOSTICS (LDT)

  • Developed and commercialized Alzheimer’s disease AclarusDx™ molecular diagnostic blood-based microarray laboratory developed test (LDT) for biomarker genomic expression profiling (Exonhit)

US FDA EMERGENCY USE AUTHORIZATIONS (EUAs) INFECTIOUS DISEASE DIAGNOSTICS
APTIMA® Rapid Response Detection Platform developed while at
Gen-Probe (circa 2004), platform later acquired by Hologic and deployed during public health emergencies in 2016 and 2020:
DIAGNOSTICS PLATFORM DEVELOPMENT
INFECTIOUS DISEASES
  • Integrated molecular and immunodiagnostic mobile biothreat detection systems for US intelligence community (Nanogen-Vectrant collaboration)
    • Demonstrated technical feasibility for point-of-care compact high-speed detection system using dual-function molecular and immunological diagnostic tests for multiple clinical analytes (> 15) and biothreat detection
  • Influenza A/B rapid detection real-time PCR platform (Nanogen-Vectrant)
  • Influenza A/B rapid detection lateral flow immunodiagnostic platform (Nanogen-Vectrant)
  • Respiratory disease panels NanoChip® 400 molecular diagnostic array (Nanogen)
  • High-throughput and point-of-care (POC) systems for blood screening and infectious disease testing (Gen-Probe > Hologic, Nanogen)
    • Developed multiple diagnostic systems for sexually transmitted infections (STIs) and bloodborne, respiratory, and enteric pathogens, as well as laboratory information systems (LIS) for clinical and public health laboratories (Gen-Probe)
    • Developed infectious disease molecular diagnostics systems for multiple respiratory pathogens using automated robotic systems, nucleic acid microarray nanotechnologies and real-time PCR platforms (Nanogen)
    • Infectious disease rapid response detection platform via APTIMA® chemistry and instrumentation platform for high-throughput diagnostic testing (Gen-Probe > Hologic)
    • Specimen collection devices and proprietary target capture systems (Gen-Probe > Hologic, Nanogen, Vectrant, Intrexon)
    • Direct Tube Sampling (DTS) liquid handling system for APTIMA® & Procleix® product lines: proprietary penetrable caps on specimen collection tube to reduce cross contamination during testing workflow (Gen-Probe > Hologic)
  • Pilot Testing and Field-Hospital Laboratory integration for rolling out first-in-kind mobile HIV / CD4 testing capability to determine efficacy of HIV anti-retroviral therapies (ART) in low-resource setting rural communities in Sub-Saharan Africa (St. Gabriel’s Hospital - Malawi)

CHRONIC DISEASES
  • Research Use Only (RUO) rapid prototyping chemistry platform for quantitation of biomarkers for oncology (Intrexon)
  • SpliceArray™ genome-wide biomarker discovery platform for biomedical research (Exonhit)
  • Molecular diagnostic array for genomic-based Cystic Fibrosis diagnostics (Nanogen)
  • Research Use Only (RUO) Alzheimer’s disease complement binding assay (The Scripps Research Institute, Department of Immunology)

ADDITIONAL PROPHYLACTIC AND THERAPEUTIC MEDICAL COUNTERMEASURES
  • AdenoVerse™ DNA vaccine development platform for infectious diseases (Intrexon)
  • Infectious disease testing and vector control interventions for mosquito-borne diseases (Gen-Probe, St. Gabriel’s Hospital - Malawi, Intrexon)
  • Global health infectious and chronic disease interventions in Sub-Saharan Africa (St. Gabriel’s Hospital - Malawi)
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Learn more here about current effort advancing Planetary Genetics COVID-19 Diagnostics Development Program.