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 hp
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

Download Mobile App





Helix COVID-19 NGS Test One of the First Sequencing-Based COVID-19 Tests To Secure FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 11 Aug 2020
Helix (San Mateo, CA, USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the Helix COVID-19 NGS Test, making it one of the first sequencing-based COVID-19 tests to be granted FDA EUA.

The test is an amplicon-based next-generation sequencing (NGS) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (nasopharyngeal swabs, oropharyngeal (throat) swab, mid-turbinate nasal swabs, and anterior nasal swabs) from individuals suspected of COVID-19 by their healthcare provider. More...
This test is highly multiplexed to enable a large number of samples to be sequenced on each instrument and is a critical part of Helix's plan to scale its COVID-19 capacity to 100,000 tests per day and potentially further. As one of the first next-generation sequencing tests authorized by the FDA, the Helix COVID-19 NGS Test will enable Helix to diversify and add redundancy to its existing supply chain for its PCR-based test, the Helix COVID-19 Test, which has also obtained EUA from the FDA.

"The authorization of our next-generation sequencing-based test is an important step forward in dramatically scaling our COVID-19 testing capacity while maintaining high sensitivity," said Marc Stapley, Helix President and CEO. "Combined with the recent funding we announced from the NIH RADx program, we will quickly become one of the highest throughput COVID-19 testing labs in the country and help millions of Americans access much-needed tests with next-day turnaround time."

Related Links:

Helix


Gold Member
Flu SARS-CoV-2 Combo Test
OSOM® Flu SARS-CoV-2 Combo Test
βeta-Hydroxybutyrate Reagent
β-Hydroxybutyrate LiquiColor®
Manual Pipetting Aid
Pipette Controllers macro
Fully Automated Urinalysis System
DxU 1800 Fully Automated Urinalysis System
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Molecular Diagnostics

view channel
Image: Guardant Health has introduced new applications for Guardant360 Liquid, expanding the test’s capabilities for treatment selection in breast and lung cancers. (Photo courtesy of Guardant Health)

Liquid Biopsy Expands Insights Into Treatment Response and Tumor Alterations

Treatment selection in advanced breast and lung cancers can be challenging when traditional biomarkers are absent and genomic findings alone do not fully clarify which therapies may be effective.... Read more

Immunology

view channel
Image: The panel expands Cepheid’s respiratory testing portfolio on the GeneXpert platform, offering laboratories greater flexibility in selecting tests based on clinical needs. (Photo courtesy of Cepheid)

Multiplex PCR Test Gains CE Marking to Support Respiratory Infection Diagnosis

Acute respiratory infections often present with overlapping symptoms, making it difficult to distinguish between viral and bacterial causes. Seasonal surges of influenza-like illness in Europe further... Read more

Microbiology

view channel
Image: VITEK PRO combines microbial identification and antimicrobial susceptibility testing on a single platform to support routine microbiology workflows and antibiotic selection. (Photo courtesy of bioMérieux)

Automated Microbial Identification and Susceptibility System Gains FDA Clearance

Antimicrobial resistance (AMR) is a leading global public health threat, causing an estimated 1.27 million deaths annually. The growing challenge of diagnosing and treating resistant infections highlights... Read more

Pathology

view channel
AI: Artificial intelligence; CNN: Convolutional neural networks; ResNet: Residual neural network. (Xing-hua Gao from The First Hospital of China Medical University, China Image Source Link: https://www.ovid.com/jnls/cmj/fulltext/10.1097/cm9.0000000000004154~deep-learning-based-computational-pathology-technologies)

Review Highlights Progress and Validation Needs for AI in Digital Pathology

Pathology remains the gold standard for disease diagnosis, but clinical laboratories face growing demands for faster, more reproducible diagnostic and prognostic workflows. Digital pathology based on whole-slide... Read more

Industry

view channel
Image: The collaboration aims to expand access to the technology through a regulated clinical diagnostics pathway in Japan.

Partnership Aims to Bring Blood-Based Alzheimer’s Testing to Japan

Alzheimer’s disease remains a growing diagnostic challenge as populations age and cognitive impairment becomes more common. In Japan, government-supported estimates project that approximately 4.... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.