Diagnosing Zika
Yelena Budovskaya

Diagnosing Zika

By Yelena Budovskaya

Skills
Project Lead Clinical validation FDA Intellectual Property Experimental Design (A/B Testing) Lab Experience Cross-functional Leadership Cross functional collaboration Business Analysis Business Strategy
Company

Xnsion LLC

Under my lead, Xnsion LLC team developed a novel technology that allows the routine diagnostic test for mosquito- and tick-borne virus detection using standard molecular laboratory equipment. Our panel of tests was designed with the intention of serving economically under-developed countries as well as providing global access to a rapid, cost-effective, and accurate test for the various flaviviruses. Due to a lack of an available vaccine, rapid diagnosis plays an important role in the early management of patients. Our invention helps to reliably and accurately identify CHIKV, ZIKV, YFV, WNV, and the other flavivirus infection at the early onset of symptoms and in asymptomatic patients in a single step RT-PCR test at the fraction of the cost of the current technologies. Our other aim is prevention and to help combat the spread of these viruses through early and rapid detection that is widely available. ▶︎ Developed, validated, and patented the Mosquito- and Tick-borne Viruses test that offers rapid detection of the Zika virus as well as other mosquito-borne viruses in a single reaction without prior RNA isolation ▶︎ Established multiple academic and industry collaborations to facilitate clinical validation for the Mosquito- and Tick-borne Viruses test ▶︎ Lead clinical validation of the Mosquito- and Tick-borne Viruses test in CLIA certified laboratory ▶︎ Designing and writing SOP's and validation reports for the clinical studies ▶︎ Cost analysis and market research for the Mosquito- and Tick-borne Viruses ▶︎ Establish and maintain functionally integrated project schedules to enable the accurate project, financial and portfolio analyses and ensure accurate inputs are provided into business planning processes ▶︎ Preparation of the validation report and extra documentation to obtain FDA approval under Emergency Use Authorization (EUA)


Yelena Budovskaya

Diagnosing Zika

By Yelena Budovskaya

Skills
Project Lead Clinical validation FDA Intellectual Property Experimental Design (A/B Testing) Lab Experience Cross-functional Leadership Cross functional collaboration Business Analysis Business Strategy
Company

Xnsion LLC

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