Rapid Deployment of a New COVID-19 ddPCR Assay in a Centralized CLIA Testing Laboratory

The availability of COVID-19 molecular testing is limited around the globe. Most assays for respiratory specimens utilize a variety of swabs, viral inactivation methods and qPCR. Here we describe the rapid development and deployment of a novel Droplet Digital PCR (ddPCR) as a complement to commonly available qPCR. The availability of the ddPCR assays not only provides additional kits in the COVID-19 testing arena but also has been shown to be a more sensitive technology to qPCR in early and recovering COVID-19 cases. The Biodesix® SARS-CoV-2 ddPCR™ Test is currently under FDA EUA review and is available for testing in the CLIA Laboratory. Specifically, this test is a single tube - triplex assay that detects two regions of the SARS-CoV-2 N gene (N1 and N2) and a human RNase P gene control. We will present on the development and validation of the test as well as on its performance in field testing of Tier 1 patients.

Dr Gary Pestano

Chief Development Officer, Biodesix, Inc, United States

Dr. Pestano is currently is the Chief Development Officer at Biodesix, a leading liquid biopsy molecular diagnostics company. He also serves as the NYS Laboratory Director of the company’s certified laboratory. His experiences have focused on assay development of molecular diagnostics in oncology and in virology, with emphasis on liquid and tissue biopsies.

Dr. Pestano is the co-inventor on multiple patents, most recently for a device used for blood collection and plasma separation. He has also fostered many collaborations in the biotechnology industry - including with Bio-Rad on the development of novel ddPCR assays intended for use in the Biodesix centralized, clinical testing laboratories in the United States.

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About the speaker:
Dr. Gary Pestano
Chief Development Officer, Biodesix, Inc, United States