Agena Bioscience's Journey of the Development and FDA Emergency Use Authorization of SARS-CoV-2 IVD Test

Jason Halsey

Senior Vice President, Research & Development and Operations

Agena Biosciences


Seminar Information

Seminar Date
January 8, 2021 - 2:00 PM

Location
Zoom

Jason Halsey

Abstract

Agena Bioscience is a San Diego based company with a MALDI-TOF Mass Spectrometry based product that clinical laboratories use for diagnostic tests for inherited diseases, oncology and pharmacogenomics.  When it became apparent COVID-19 was to become a global pandemic, Agena embarked on the development of a SARS-CoV-2 detection test.  Over the following months, Agena Bioscience successfully obtained FDA Emergency Use Authorization (EUA) and EU CE-IVD regulatory approvals.  There were set-backs along the way to success for Agena, as infectious disease IVD was a new arena for Agena, and this presentation will share the journey and learnings, as well as an introduction to Agena Bioscience and the MassARRAY genetic analysis instrument.

Speaker Bio

Jason Halsey joined Agena Bioscience in May 2016 as Senior Vice President, R&D and Operations. Jason most recently was Vice President of Instrument and Regulated Operations for the Life Science Solutions Group of Thermo Fisher Scientific. In this role, he oversaw the development, manufacturing, depot repair and distribution of instruments, accessories and reagents. During his 19 years with Thermo Fisher Scientific (formerly Life Technologies and Applied Biosystems), Jason held various roles in operations and R&D, and was engaged in the launch of over 50 instrument systems including the 7900, 9700, and QuantStudio. Jason holds 4 patents, 2 pending patents, and is the co-author of 2 book chapters in PCR methods. Prior to joining Life Technologies, Jason was a laboratory manager and a consulting engineer. Jason received his Bachelors of Science in Bio-Engineering from University of California at San Diego and a Masters of Business Administration from Golden Gate University.