Karius: Next Gen Sequencing for Infectious Disease Diagnostics

Despite recent guidance from the FDA on software as a medical device, the path to regulatory approval and clinical adoption for digital diagnostics and therapeutics is as yet relatively unclear. I joined genomic diagnostics company, Karius, as a Product Manager in 2016 to learn about traditional biotech product development,¬†from analytical and clinical validation studies to implementing quality management systems and design controls for FDA and CE certification. I led user research, conducting interviews with infectious disease physicians and laboratory directors, built the product roadmap for 2018, and designed and implemented the digital infrastructure to support Karius’ production laboratory.

The Karius test uses next generation sequencing to detect over 2000 microbes from a single blood sample.

www.kariusdx.com

Karius test

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