DETECTION PLATFORM & NEW PRODUCT DEVELOPMENT

For over 25 years I have been driven through my research and industry work to advance solutions for complex problems impacting health globally. Biotechnology innovation and new product development underpin some of the most impactful public health interventions in recent generations. I have been fortunate and am grateful to have contributed to some of them as part of my work developing molecular diagnostic technologies, as well as, first-in-class genetic engineering programs for health, food and environment.

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:
  • 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)
ORGANIZATIONS
PLANETARY GENETICS LLC | Co-Founder and CEO
Currently, I am the Co-Founder and Chief Executive Officer of Planetary Genetics LLC. Our team is working to advance COVID-19 medical diagnostics. Learn more here about Planetary Genetics COVID-19 Diagnostics Development Program.

www.planetary-genetics.com

ROSSI BIXBY + ASSOCIATES | Co-Founder and Principal Consultant
ROSSI BIXBY + ASSOCIATES help our clients achieve their mission impact across commercial ventures and not-for-profit initiatives by focusing on four key areas:

TECHNOLOGY ANALYSIS & COMMERCIAL DILIGENCE: We provide de-risking assessments of new opportunities rendering feedback on technology feasibility, challenges, market, and valuation for qualified groups.

INNOVATION & NEW TECHNOLOGY DEVELOPMENT STRATEGIES: We create innovation strategies for establishing new biotechnology ventures designed to positively impact health and the environment.

TECHNICAL & STRATEGIC COMMUNICATIONS: We communicate to raise awareness for initiatives in support of the public good and commercial ventures benefiting health and the environment.

TECHNOLOGY PARTNERSHIPS: We advise on positioning and development of novel technologies in their respective markets to catalyze investor awareness and facilitate financing for select partners currently in research and development stages.

Advancing biotechnology innovations that deliver personal and population-level impact

www.rossibixby.com

MEDICAL DIAGNOSTICS | Gen-Probe (Hologic) | Nanogen | Vectrant | Exonhit | Intrexon
I've helped develop systems for infectious disease diagnostics, as well as, biodefense and biothreat detection systems at multiple companies including Gen-Probe (now Hologic (Nasdaq: HOLX) and Grifols (Nasdaq: GRFS)), Nanogen, and Vectrant. At Gen-Probe, we successfully closed the seroconversion window for HIV by shifting testing of the nation’s blood supply to molecular testing for HIV, HCV, and HBV, as well as, launched a high-throughput testing platform for infectious diseases. The instrumentation and chemistry platform technologies we developed at Gen-Probe are well placed throughout the world in blood banks such as the American Red Cross and Japanese Red Cross, large reference laboratories including Quest, LabCorp, etc., hospital systems, as well as, military and public health laboratories.

[UPDATE MAY 2020:] Having developed the APTIMA® rapid response detection platform while at Gen-Probe, it is with great confidence that I welcome the granting of US FDA Emergency Use Authorization for the Hologic APTIMA SARS-CoV-2 assay. The assay was the first COVID-19 product selected for development through ASPR's BARDA BAA process in response to COVID-19.

My work in the field of chronic disease diagnostics includes developing an Alzheimer's disease molecular test and a genomic-based protein splice variant molecular screening test capabilities at Exonhit, as well as, a rapid prototyping chemistry platform for quantitation of biomarkers for oncology at Intrexon (formerly Nasdaq: XON, now restructured as Precigen (Nasdaq: PGEN) after divestment of bioengineering assets to refocus on healthcare).

As Director of Technology and Innovation at Intrexon I worked to advance programs for biodefense, medical diagnostics, and public health / one health initiatives focused on advancing environmental and medical countermeasures for infectious diseases and biothreats facing our public health, military and intelligence communities.
GLOBAL HEALTH | Sub-Saharan Africa
My real world public health and global health experience spans development of applications for advanced technologies in the US, as well as, abroad with intended use for low resource settings in developing countries. I spent time overseas in Sub-Saharan Africa deploying HIV interventions in rural low resource settings at and around St. Gabriel's Hospital - Malawi prior to moving to Washington DC to begin my public health epidemiology graduate study.
ACADEMIC RESEARCH | The Scripps Research Institute | University of California, San Diego
My work with biotechnologies began in academia at The Scripps Research Institute, Department of Immunology where I worked in the Neil Cooper Lab while earning my undergraduate degree in biology from University of California, San Diego.
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Learn more here about current effort advancing Planetary Genetics COVID-19 Diagnostics Development Program.


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