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As a qPCR-based COVID-19 test, the Advanta™ Dx SARS-CoV-2 RT-PCR Assay is designed to be run on the Fluidigm Biomark™ HD microfluidics platform. Developed through a collaboration with researchers at the McDonnell Genome Institute and the Department of Genetics at the Washington University School of Medicine in St. Louis, the test requires lower sample volume and uses an industry-leading 15 µL of sample input which is 10 times less than traditional microwell RT-PCR methods. For the specifics of the process, once the patient sample has been collected, the sample is then processed through Fluidigm’s Juno and Biomark HD systems with an instrument run time of less than 3 hours significantly improving speed to results compared to other tests currently on the market. In terms of the accuracy of the test, in a clinical study associated with the EUA submission, Fluidigm’s saliva-based assay demonstrated 100 percent agreement with results from paired nasopharyngeal samples tested with already authorized molecular tests. Additionally, over the past several months as we have seen the rise of a number of different COVID-19 variants, Fluidigm’s saliva-based assay has provided an effective way at identifying which possible variant an individual could be infected with while also providing the information we need about new variants that may arise over time.
Fluidigm’s Advanta™ Dx SARS-CoV-2 RT-PCR Assay differs from other COVID-19 tests available on the market today through the combination of an extraordinary throughput per system mixed with a robust supply chain resulting in enhanced testing capacity and vast improvements in speed to results. As a result of Fluidigm’s proprietary technology, more patient samples per batch have been processed compared to microwell plate-based PCR technology which has resulted in thousands of results per day on a single system. As a faster and more economical approach to COVID-19 testing, Fluidigm’s saliva-based assay has provided patients and healthcare providers with a convenient, stress-free, and most importantly, extraction-free testing solution that is also significantly less costly than other collection devices. Speaking to the throughput of the assay, more than 192 results are generated every 30 minutes in addition to the thousands of samples processed each day. Additionally, as an extraction-free PCR test, the elimination of an extraction step effectively mitigates supply chain constraints helping to provide the country with accessible and accurate testing solution during a critical time during the pandemic.
Fluidigm has initiated a number of partnerships and collaborations with companies and institutions like AZOVA, Stanford University and Helix Diagnostics to continue researching COVID-19 and further bolster testing initiatives. To further increase testing for students across the country as they returned to in-person learning, Fluidigm created a new program to provide millions of its Advanta Dx SARS-CoV-2 RT-PCR Assay extraction-free saliva-based test to colleges and universities across the country. As a result, major U.S. universities offered Fluidigm’s testing programs to its students including UPENN, Oklahoma University and Washington University as well. Most recently, Fluidigm partnered with Rover Labs to provide its assay to 50 New York City public schools from all five boroughs for a pilot program further enabling affordable and accessible testing for schools and students.