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



Gold Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
Collection and Transport System
PurSafe Plus®
New
Rapid Molecular Testing Device
FlashDetect Flash10
New
Pipette
Accumax Smart Series
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: Over 100 new epigenetic biomarkers may help predict cardiovascular disease risk (Photo courtesy of 123RF)

Routine Blood Draws Could Detect Epigenetic Biomarkers for Predicting Cardiovascular Disease Risk

Cardiovascular disease is a leading cause of death worldwide, yet predicting individual risk remains a persistent challenge. Traditional risk factors, while useful, do not fully capture biological changes... Read more

Hematology

view channel
Image: New research points to protecting blood during radiation therapy (Photo courtesy of 123RF)

Pioneering Model Measures Radiation Exposure in Blood for Precise Cancer Treatments

Scientists have long focused on protecting organs near tumors during radiotherapy, but blood — a vital, circulating tissue — has largely been excluded from dose calculations. Each blood cell passing through... Read more

Immunology

view channel
Image: The VENTANA HER2 (4B5) test is now CE-IVDR approved (Photo courtesy of Roche)

Companion Diagnostic Test Identifies HER2-Ultralow Breast Cancer and Biliary Tract Cancer Patients

Breast cancer is the most common cancer in Europe, with more than 564,000 new cases and 145,000 deaths annually. Metastatic breast cancer is rising in younger populations and remains the leading cause... Read more

Pathology

view channel
Image: An adult fibrosarcoma case report has shown the importance of early diagnosis and targeted therapy (Photo courtesy of Sultana and Sailaja/Oncoscience)

Accurate Pathological Analysis Improves Treatment Outcomes for Adult Fibrosarcoma

Adult fibrosarcoma is a rare and highly aggressive malignancy that develops in connective tissue and often affects the limbs, trunk, or head and neck region. Diagnosis is complex because tumors can mimic... Read more

Technology

view channel
Image: Conceptual design of the CORAL capsule for microbial sampling in the small intestine (H. Mohammed et al., Device (2025). DOI: 10.1016/j.device.2025.100904)

Coral-Inspired Capsule Samples Hidden Bacteria from Small Intestine

The gut microbiome has been linked to conditions ranging from immune disorders to mental health, yet conventional stool tests often fail to capture bacterial populations in the small intestine.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.