New FDA Authorized COVID-19 Molecular POC Test Delivers Lab-Quality Results Without the Wait

A molecular point-of-care test for the detection of SARS-CoV-2 enables lab-quality results without the wait to detect or rule out COVID-19 in less than 30 minutes.

Talis Biomedical Corporation (Menlo Park, CA, USA) has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for its Talis One COVID-19 Test System - a nucleic acid amplification test (NAAT). The Talis One COVID-19 test runs on the Talis One integrated system that includes a compact instrument, self-contained, single-use test cartridges and software for reporting results. The Talis One system is a compact, sample-to-answer, molecular diagnostic solution that can be rapidly deployed into a variety of healthcare settings to diagnose infectious diseases at the point-of-care. The Talis One test system is designed for use both in CLIA moderate and high complexity laboratory settings and non-laboratory CLIA-waived settings, such as physicians’ offices, hospital emergency departments, urgent care clinics, ambulatory surgery centers, elder care/assisted living facilities, places of work and education or cancer treatment clinics and dialysis centers. Designed for cloud connectivity, the instrument is being further developed to enable easy results sharing and simplified patient data management in the future.

The Talis One tests integrate robust sample preparation with highly-optimized and rapid isothermal nucleic acid amplification to achieve test performance faster than traditional polymerase chain reaction (PCR) tests. COVID-19 is the first infectious disease that the Talis One system is designed to detect. The Talis One COVID-19 Test System targets two genes, ORF1ab and N, to optimize sensitivity and the inclusion of variants. The ORF1ab and N gene were selected for their conserved nature and their unique sequence specific for SARS-CoV-2. In a clinical study, the Talis One COVID-19 Test System demonstrated 100% concordance with the comparator test results, including both the positive and negative percent agreements. All samples were collected and tested in point-of-care settings.

Talis assessed the impact of 10 distinct COVID-19 variants demonstrating high sensitivity of detection. At the time of testing in June, the emerging Delta variant was not available to be included in the study. Subsequently, the company conducted a separate bioinformatic analysis for the Delta variant as well as testing in vitro transcript samples to support its EUA submission. In testing for all these variants, including Delta, no loss in sensitivity or impact on the Talis One COVID-19 Test System’s performance was detected. Talis is continuing to monitor new COVID variants as they arise.

“With the ongoing emergence of variants and prevalence of COVID-19 cases, the need for accurate and rapid high quality testing options remains critical, especially as our society returns to work, school and other congregate settings,” said Kim Popovits, interim chief executive officer of Talis. “With the authorization of the Talis One COVID-19 Test System, we can now put testing in the hands of healthcare providers to help detect or rule out infection with confidence and prevent broader transmission while minimizing disruption to our daily lives.”

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Talis Biomedical Corporation