Twist Bioscience and Biotia Receive U.S. FDA Emergency Use Authorization for First Hybridization Capture-Based Next-Generation Sequencing SARS-CoV-2 Assay - Seite 2

“While there are many available high-throughput diagnostic tests available for COVID-19, our solution enables clinicians and researchers the ability to sequence and surveil the evolution of mutations in the virus over time and geography. This is especially significant at the moment as more variants are identified that are more contagious,” said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. “Importantly, while many labs are conducting individual sequencing runs for each patient sample, this assay and the accompanying software provide a way to batch about 100 samples together, providing actionable information that can then be used to inform public health and clinical decisions.”

The assay utilizes Twist Bioscience’s unique ability to rapidly develop virus-specific panels through DNA synthesis and Biotia’s comprehensive data analysis software and reporting capabilities. The SARS-CoV-2 NGS Assay was validated on a NextSeq 550 Sequencing System. Because the assay analyzes the full sequence data, the test reduces the likelihood of a false-negative result. In contrast, a majority of SARS-CoV-2 tests based on polymerase chain reaction (PCR) only identify limited genetic markers of the virus.

In the separate and free RUO report, the full sequence of the virus is profiled, enabling improved understanding of mutations, genetic variability, and the evolution of the virus as it’s transmitted. A recent pre-print on MedRxiv and submitted for peer review details results of the NGS SARS-CoV-2 Assay with the COVID-DX Solution to detect the virus and its genetic variants.

"As SARS-CoV-2 continues to evolve, the need for insightful research tools leveraging NGS and evolutionary principles has become starkly clear,” commented Niamh O’Hara, Ph.D., CEO and co-founder of Biotia. “This assay also greatly expands testing options in the clinical space, bringing new technology to patients.”

“This test opens the door to a new diagnostic method and can also guide vaccine research, since it captures viral variants so well,” noted Christopher Mason, Ph.D., co-founder of Biotia, “We are elated to get an FDA EUA for our test, which brings needed tools into the fight against COVID-19, as well as pioneering these capture methods for tracking other pathogens in the future.”

About the Test and Interface

The SARS-CoV-2 NGS Assay is an in vitro diagnostic test intended for the qualitative identification of the SARS-CoV-2 virus from nasopharyngeal (NP), oropharyngeal (OP), anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirates, nasal wash/aspirates as well as from bronchoalveolar lavage (BAL) specimens from individuals suspected of having COVID-19 by their healthcare provider. The SARS-CoV-2 NGS Assay, which includes Twist Bioscience’s SARS-CoV-2 synthetic RNA controls, along with the Biotia COVID-DX software which generates a clinical report and RUO report, covers the entire virus genome and identifies all strains of SARS-CoV-2 in samples with as few as 800 viral copies per milliliter.