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

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



Platinum Member
Fully Automatic ACLIA Analyzer
MAGLUMI X8
Gold Member
SARS-CoV-2 PCR Test
Macurra SARS-CoV-2 PCR Kit
New
Fully Automated Urinalysis System
DxU 1800 Fully Automated Urinalysis System
Japanese Encephalitis Test
Japanese Encephalitis Virus Real Time PCR Kit
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 researchers Manel Pérez Pons y Carlos Rodriguez Muñoz at the IRBLleida laboratory (Photo courtesy of IRBLleida)

New Blood RNA Markers Help Advance Precision Medicine for Respiratory Patients

Risk stratification in hospitalized respiratory disease, particularly among older adults with COVID-19, remains challenging despite rich clinical datasets. Blood-based non-coding RNA biomarkers are promising,... Read more

Microbiology

view channel
Image: The “broth” used to monitor red blood cell depletion in whole blood spiked with one colony-forming-unit of E. coli bacteria, each incubated at different orbital shaking speeds—left to right: 0 RPM, 65 RPM, 120 RPM and 200 RPM—after four hours of incubation. This culturing raises a bacteria-rich, plasma-like layer of bacteria to the top of the vials, while clusters of stuck blood cells known as a Rouleaux formation sink to the bottom. (Image Credit: Pak Kin Wong)

New Diagnostic Workflow Identifies Bloodstream Pathogens and Antibiotic Response in Hours

Sepsis is a life-threatening complication of infection that affects more than 1.5 million patients annually in the United States and contributes to roughly one in three in-hospital deaths.... Read more

Pathology

view channel
Image: Researchers evaluated AI models that quantify tumor-infiltrating lymphocytes (TIL) on routine breast tissue slides, where higher TIL levels reflect stronger antitumor response and improved breast cancer outcomes (Image Credit: Shutterstock)

AI Matches Pathologists in Predicting Breast Cancer Prognosis from Immune Cells

Breast cancer is the most common cancer in Australian women, with more than 20,000 cases each year. Prognosis can be informed by counting tumor-infiltrating lymphocytes (TILs) on routine pathology slides,... Read more

Industry

view channel
Image: RaDaR ST uses a tumor-informed approach that identifies up to 48 patient-specific variants through whole-exome sequencing and tracks those variants in plasma to detect circulating tumor DNA (ctDNA) at very low variant allele fractions (VAFs) (Photo courtesy of Neogenomics)

Tumor-Informed MRD Assay Gains Medicare Coverage for Immunotherapy Monitoring

NeoGenomics’ RaDaR ST molecular residual disease (MRD) assay has received expanded coverage from the Centers for Medicare & Medicaid Services’ Molecular Diagnostic Services Program (MolDX) for monitoring... Read more
Copyright © 2000-2026 Globetech Media. All rights reserved.