Helen V Hsieh Email & Phone Number

San Diego County, California, United States

Responsible for research and development of point-of-care medical diagnostics.

Greater Seattle Area

Evaluate, transfer, and develop technologies for infectious disease diagnostics. Responsible for independently designing experiments, developing innovative and creative assays, developing standard, benchmarking reference assays, troubleshooting, analyzing and interpreting data, writing and implementing SOPs with appropriate documentation, evaluating emerging technologies and markets, presenting results internally and externally, training co-workers and interns, and maintaining laboratory equipment, supplies, and laboratory notebooks. Areas of clinical interest include COVID-19, malaria, tuberculosis, and neglected tropical diseases. Areas of technical expertise include LFAs, SIMOA, multiplex ELISAs, BLI, and Hamilton STAR robotics.COVID-19 (2020)• Plan and execute antibody screening experiments using an in-house robotic system for development of a COVID-19 rapid diagnostic test. • Over 600 antibody pairs have been screened in 2 months.Malaria Antigen LFAs (2017-2020)• Developed and optimized HRP2 and pLDH malaria LFAs. These LFAs are currently in development with a commercial partner. • Developed highly sensitivity reference assays for use in our US-based laboratory.• Researched, evaluated, and created SOPs for a commercial reference assay to be used at the field sites. • Identified design issue in development of a multiplex LFA that allowed for early correction to timelines for project planning.

Greater Seattle Area

Malaria Serology LFAs (2016-2017)• Developed model serology systems for use in developing serology LFAs; this work was used to facilitate development of malaria serology LFAs and reference assays. • The malaria serology LFAs performed well in comparison to the gold standard Luminex bead assay. Identified that a commonly used fusion protein could be problematic for use in tropical diseases diagnostics. Tuberculosis (2015-2016)• Screened TB LAM antibody pairs for LFA development. • Managed relationship with commercial vendor for development and production of initial prototype LFAs for field evaluation.

Research Triangle Park

Invented, evaluated, transferred, and developed technologies for medical diagnostics. Notable accomplishments include inventing new diagnostic assays that were patented and/or commercialized, designing an in-house production line, writing and implementing GMP SOPs with appropriate documentation, and wining a grant.NANOTECHNOLOGY (2006-2014)• Identified opportunity and co-authored successful grant application "Simple and Rapid Diagnosis of Preeclampsia" for the Saving Lives at Birth 2014 competition. http://savinglivesatbirth.net/summaries/285• Designed innovative nanoparticle assays as well as standard diagnostic assays (e.g. immunoassays, ELISA, lateral flow). Assay methods were incorporated into the new product line, the BD Veritor™ System.• Designed and executed scale-up of diagnostic test units by successfully assembling an in-house bulk production line complete with GMP SOPs. This production line produced up to 2000 individual units per lot, leading to high quality data, and demonstrating the easy-to-use test format. • Evaluated possible markets for BD nanotechnology. GLUCOSE MONITORING (2000-2006)• Co-invented initial detection and attachment chemistries for a Continuous Glucose Monitoring (CGM) device. CELL BIOLOGY (1999-2000)• Evaluated technical and market opportunities in cell biology.MOLECULAR BIOLOGY (1993-1999)• Contributing member of fluorescence strand displacement amplification team; co-inventor on seven patents. This family of patents form the basis of the BDProbetec™ ET System.• Evaluated aptamer technology for BDT.Patents and selected patent applications below.

Chapel Hill, Nc

Advisor-Nancy L Thompson

Phd, Chemistry

Thesis: Investigation of the Interaction Between IgG and Mouse Fc gamma Receptor Using Total Internal Reflection Fluorescence Microscopy

Ba, Chemistry