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
Sekisui Diagnostics

Download Mobile App





Genetron Receives FDA Emergency Use Authorization for SARS-CoV-2 RNA Test

By LabMedica International staff writers
Posted on 09 Jun 2020
Genetron Health (Beijing, China) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration for the company’s independently developed detection kit for the novel coronavirus. More...


The company’s new Genetron SARS-CoV-2 RNA Test kit has also received approval for export from the relevant authorities in China as well as obtained CE marking. Genetron SARS-CoV-2 RNA Test is an accurate, fast, contamination-free testing solution, which efficiently detects large-scale samples for the novel coronavirus. It detects two different and highly specific gene sequences of SARS-CoV-2: ORF1ab and N, which improves both its accuracy and specificity. It also includes an internal reference to prevent possible false negative results. Each test is capable of detecting SARS-CoV-2 RNA as low as 10 copies.

Using patented technology, the One-Step Seq Method, the process integrates reverse transcription of viral RNA and quantitative PCR reaction in a single step. The entire process takes less than 2.5 hours, including only 10 minutes of hands-on time. Additionally, the application of contamination resistant dUTP and UDG enzymes allows the system to degrade non-specific and nucleic acid-contaminated PCR products.

Related Links:
Genetron Health



Gold Member
Flu SARS-CoV-2 Combo Test
OSOM® Flu SARS-CoV-2 Combo Test
βeta-Hydroxybutyrate Reagent
β-Hydroxybutyrate LiquiColor®
Microbiology Laboratory Automation Solution
BD Kiestra™ ReadA+BarcodA
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

Molecular Diagnostics

view channel
Image: The automated multiplex PCR assay runs on the BioFire Spotfire Vaginitis System, bringing molecular vaginitis testing to the point of care (Photo courtesy of bioMérieux)

Molecular Vaginitis Panel Gains FDA Clearance and CLIA Waiver for Point-of-Care Use

Vaginitis affects most women at least once in their lifetime and can cause painful, disruptive symptoms. Common causes include bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis, reflecting... Read more

Immunology

view channel
Image Credit: iStock

Antibody Profiling Predicts Inflammatory Bowel Disease Years Before Diagnosis

Inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis, involves abnormal immune responses that cause persistent inflammation and damage in the digestive system.... Read more

Pathology

view channel
Image: The CE-marked software IVD combines digital histopathology and clinicopathological data to generate a prognostic classification (Image Credit: Shutterstock)

Digital Pathology Test Stratifies Recurrence Risk in Early Breast Cancer

In hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer, accurate recurrence-risk assessment helps guide treatment decisions. However, individual risks... Read more

Technology

view channel
Image: Signals LabGistics uses AI to turn natural-language instructions and SOPs into coordinated scientific workflows, helping connect teams, systems, and processes. (Photo courtesy of Revvity)

New AI-Powered System Aims to Streamline Laboratory and Manufacturing Workflows

Scientific laboratories supporting drug development, biotechnology, and materials research increasingly rely on coordinated digital workflows to move data, samples, and activities across teams.... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.