Takara Bio and BioSyntagma Develop New High-Throughput Method for Detecting SARS-CoV-2

Takara Bio USA, Inc. {(TBUSA) Mountain View, CA, USA} is collaborating with BioSyntagma, Inc. (Phoenix, AZ, USA) and their partners to develop and validate a new high-throughput method for detecting SARS-CoV-2.

The method employs automation technology and reagents from TBUSA to detect viral RNA via real-time PCR and will enable rapid, large-scale testing of thousands of patient samples per day. The method uses TBUSA’s SmartChip real-time PCR instrument, chips, and reagents to run 5,184 reactions per chip in less than 30 minutes of direct hands-on time. Each reaction is at nanoliter scale, which reduces variability via elimination of the standard preamplification step and reduces costs via decreased reagent volume. The SmartChip Real-Time PCR System is already widely used for detection of antibiotic and antimicrobial resistance around the world, and is ideally suited to address the major need for rapid and accurate SARS-CoV-2 detection.

The new SmartChip testing method will be adopted by molecular testing labs that are certified by CLIA (Clinical Laboratory Improvement Amendments) and therefore eligible to develop and perform COVID-19 diagnostic tests. BioSyntagma and partners are seeking an Emergency Use Authorization (EUA) from the FDA for COVID-19 detection using the TBUSA SmartChip method. Ipsum Diagnostics, LLC and Hackensack University Medical Center—two of TBUSA’s customers in the US—have already obtained EUAs for their COVID-19 tests using Takara Bio’s one-step RT-PCR reagents.

“As shelter-in-place orders are lifted, controlling the COVID-19 pandemic will depend on our ability to detect SARS-CoV-2 from a large number of samples with precision, reproducibility, and speed,” said President of TBUSA Carol Lou. “To support this effort, we optimized our existing chemistries and developed SmartChip protocols that maximize the number of samples processed while minimizing costs. The work we have accomplished with BioSyntagma, plus their partners’ further development of diagnostic tests based on our work, will contribute to comprehensive and faster detection of COVID-19.”

“The rapid development of this novel COVID-19 detection method was made possible through a highly productive collaboration between BioSyntagma and TBUSA, and the results of this effort will soon have an impact on the ability to detect SARS-CoV-2 in nasal and saliva samples from many patients,” said David Richardson, CEO of BioSyntagma.

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Takara Bio USA, Inc.
BioSyntagma, Inc.