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


Platinum Member
Fully Automatic ACLIA Analyzer
MAGLUMI X8
Gold Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
LAIR2 Antibody Pair Set
LAIR2 Antibody Pair [Biotin]
HPV Test
Allplex HPV28 Detection
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

Clinical Chemistry

view channel
Image: A large, international study led by City of Hope found that the new, investigational liquid biopsy, called PANXEON, was highly sensitive in detecting stage 1 and 2 pancreatic cancer and had a low rate of false positives. The test was also able to identify high-grade dysplasia, a precancerous condition of the pancreas, potentially enabling intervention before cancer develops. (Photo courtesy of City of Hope)

Multi-Biomarker Blood Test Shows Promise for Early Pancreatic Cancer Detection

Pancreatic cancer has the lowest survival rates of any cancer, with only 14% of patients alive five years after diagnosis. The disease is typically discovered after it has spread, and an estimated 90%... Read more

Molecular Diagnostics

view channel
Image: NTM are about 200 environmental bacteria found in soil and water that can cause chronic, tuberculosis-like lung infections but are distinct from the Mycobacterium tuberculosis complex (Image Credit: Adobe Stock)

Rapid CRISPR Test Identifies Nontuberculous Mycobacteria Species from Respiratory Samples

Chronic lung infections caused by nontuberculous mycobacteria (NTM) are increasingly recognized but frequently mistaken for tuberculosis, complicating diagnosis and care. These infections may affect as... Read more

Immunology

view channel
Image: Although many people harbor latent Epstein-Barr virus (EBV), growing evidence has linked the virus to MS pathobiology (Image Credit: Adobe Stock)

Blood EBV Activity Biomarkers May Predict Multiple Sclerosis Relapse Months Ahead

Predicting relapse in multiple sclerosis (MS) remains difficult, limiting opportunities for timely intervention and monitoring. Although many people harbor latent Epstein-Barr virus (EBV), growing evidence... Read more

Microbiology

view channel
Image: Graphical Abstract (Jose A. Céspedes, Maria I. Montañez, Isabel M. Jiménez, et al. Magnetic nanoparticles enable clinically relevant in vitro diagnosis of beta-lactam allergy. Materials Today Bio (2026). DOI: 10.1016/j.mtbio.2026.103356)

Magnetic Nanoparticles Enable More Sensitive Beta-Lactam Allergy Testing

Penicillin allergy labels are common in clinical practice, yet many are incorrect and can lead to suboptimal antibiotic choices. Although 8%–25% of people report a penicillin allergy, only 1%–10% are truly... Read more

Pathology

view channel
image Credit: iStock

Tumor Budding Grading May Predict Chemotherapy Benefit in Resected Lung Squamous Cancer

Outcomes after resection for lung squamous cell carcinoma (SqCC) vary substantially, and the uneven benefit of adjuvant chemotherapy complicates postsurgical treatment decisions. Pathologic markers that... Read more

Technology

view channel
Image: ADLM recommends that emerging AI tools follow the same professional oversight, quality, validation, and monitoring standards as traditional clinical testing within CLIA’s existing framework (Image Credit: Adobe Stock)

ADLM Calls for CLIA Updates to Support Safe AI Use in Laboratory Medicine

Clinical laboratories increasingly use artificial intelligence to verify, interpret, and report results, but safeguards under the Clinical Laboratory Improvement Amendments (CLIA) were designed in 1992.... Read more

Industry

view channel
Image: The acquisition adds Convergent Genomics’ UroAmp platform and proprietary urinary tumor DNA technology to Veracyte’s portfolio (Photo courtesy of Convergent Genomics)

Veracyte Acquisition Expands Urine-Based Bladder Cancer Monitoring Capabilities

Veracyte, Inc. has acquired Convergent Genomics, expanding its urology diagnostics offerings with the company’s UroAmp platform and proprietary urinary tumor DNA (utDNA) technology. UroAmp has been clinically... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.