We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
GENRUI BIOTECH INC.

Download Mobile App





First Hybridization Capture-Based Next-Generation Sequencing SARS-CoV-2 Assay Receives FDA EUA

By LabMedica International staff writers
Posted on 25 Mar 2021
Print article
Illustration
Illustration
The SARS-CoV-2 Next-Generation Sequencing (NGS) Assay, an in vitro diagnostic test, has become the first hybridization capture-based NGS SARS-CoV-2 assay to be granted Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).

Twist Bioscience Corporation (San Francisco, CA, USA) and Biotia, Inc. (New York, NY, USA) have received EUA from the US FDA for the SARS-CoV-2 NGS Assay. The SARS-CoV-2 NGS Assay is an in vitro diagnostic test, a highly sensitive nucleic acid hybridization capture-based assay, intended for the detection of SARS-CoV-2 RNA.

The SARS-CoV-2 NGS Assay has the ability to analyze the entire RNA viral sequence, to determine the presence or absence of the virus. Furthermore, in an optional research-use only (RUO) report the software analyzes the RNA sequence to detect genetic variants and lineages of SARS-CoV-2. The hybridzation capture-based approach utilized in this assay maximizes the number of genetic variants identified, where other sequencing methods may miss mutations in certain regions.

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.

“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.”

"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.”


Related Links:
Twist Bioscience Corporation
Biotia, Inc.


Gold Supplier
SARS-CoV-2 (COVID-19) Antibody Test
INgezim COVID 19 CROM
New
Gold Supplier
Viral Transport Medium Tube (Saliva sample collector)
Viral Transport Medium Tube
New
Silver Supplier
COVID-19 Ag Rapid Test
COVID-19 Ag Rapid Test Kit
New
SARS-CoV-2 Recombinant Antigens
SARS-CoV-2 Recombinant Antigens

Print article
BIOHIT  Healthcare OY

Channels

Molecular Diagnostics

view channel
Image: Randox Discovery Diagnostic Analyzer Wins 2021 Red Dot Award for High Design Quality (Photo courtesy of Randox Laboratories)

Randox Discovery Diagnostic Analyzer Wins 2021 Red Dot Award for High Design Quality

Randox Laboratories’ (Crumlin, UK) Discovery, a diagnostic analyzer which can consolidate molecular and immunoassay testing on one compact benchtop platform, has received the 2021 Red Dot Award for High... Read more

Industry

view channel
Image: Eppendorf Centrifuge 5910 Ri (Photo courtesy of Eppendorf AG)

Eppendorf Introduces Multipurpose Centrifuge 5910 Ri to Accelerate Results

Eppendorf AG (Hamburg, Germany) has introduced a new centrifuge designed to increase efficiency in the laboratory, Centrifuge 5910 Ri, a successor to the company’s popular Centrifuge 5910 R.... Read more
Copyright © 2000-2021 Globetech Media. All rights reserved.