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Ultra-High-Volume COVID-19 Test to Enable Genomic Diagnostic Testing and Population Screening For 40,000 Samples per Day

By LabMedica International staff writers
Posted on 21 Aug 2020
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A novel approach using molecular barcodes for viral RNA to perform ultra-high throughput genomic testing for SARS-CoV-2 may enable processing of over 40,000 patient samples per day.

Veracyte, Inc. (South San Francisco, CA, USA) and MAVIDx, Inc. (Miami, FL, USA) have entered into an agreement for MAVIDx to develop ultra-high throughput genomic testing for SARS-CoV-2 on the nCounter Analysis System, Veracyte’s diagnostics platform. The agreement is intended to enable diagnostic testing and population screening for COVID-19 at an unprecedented scale - up to 40,000 samples per day performed on the easy-to-use nCounter instrument – using technology that attaches molecular barcodes to individual RNA molecules of the virus.

As per the agreement, MAVIDx will develop, validate, secure regulatory approvals for and commercialize its SARS-CoV-2 and other infectious disease tests, including for influenza, on the nCounter system. MAVIDx’s in-development test is intended to detect and quantify SARS-CoV-2 copy numbers from nasal or throat swabs, using the simple workflow of the nCounter system, with minimal manual handling. The technology being developed by MAVIDx is designed to process up to approximately 9,000 patient samples at a time on a single cartridge, with the ability for a laboratory to potentially run up to five cartridges or more on the instrument during a nine hour workday.

“The COVID-19 pandemic has created a need for scalable diagnostic testing and population screening that we believe is not addressable with current technology, which is typically laborious and limited in capacity,” said Krassen Dimitrov, Ph.D., chief executive officer of MAVIDx. “With our proprietary technology that allows patient results to be assessed from a highly multiplexed assay configuration, combined with the nCounter system’s proven accuracy and ability to perform high-throughput testing in an easy-to-use manner, we believe we can help address this growing global health need.”

“We are pleased to partner with MAVIDx and believe that their novel front-end technology, combined with the nCounter platform, has the potential to help make COVID-19 testing widely available in clinical settings, as well as in the workplace, schools or other venues,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “We look forward to supporting their efforts and to expanding our reach into this new area of significant unmet need.”

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