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
PURITAN MEDICAL

Roche Diagnostics

Develops, manufactures, and markets a wide range of in vitro diagnostic systems, instruments, reagents, and tests read more Featured Products: More products

Download Mobile App





Roche Secures FDA Emergency Use Authorization for Elecsys IL-6 Test to Identify Severe Inflammatory Response in COVID-19 Patients

By LabMedica International staff writers
Posted on 02 Jul 2020
Roche (Basel, Switzerland) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its new Elecsys IL-6 test to help in identifying COVID-19 patients at a high risk of severe inflammatory response.

The IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum or plasma and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation. More...
The FDA EUA now makes IL-6 testing accessible to patients in the US to assist in identifying severe inflammatory response in patients with confirmed COVID-19 and is also available in markets accepting the CE-mark. The test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed COVID-19 illness requires mechanical ventilation.

IL-6 is released by immune cells, once they are activated by virus, bacteria or other immune cells. IL-6 acts like a messenger to activate other immune cells to fight the infection. Because IL-6 is released so early during a severe infection, it helps physicians to identify severely ill COVID-19 patients as early as possible. Hospitals and reference laboratories can run the test on Roche’s fully-automated cobas e analyzers which can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending upon the analyzer.

“The FDA EUA approval of Elecsys IL-6 is another step in our commitment to deliver fast and reliable diagnostic tests to help fight the coronavirus pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “In the current situation, time is specifically critical. The test could help physicians in the quick identification of severe inflammatory response in patients infected with the SARS CoV-2 virus.”



Gold Member
Multiplex Genetic Analyzer
MassARRAY Dx Analyzer (Europe only)
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
Silver Member
Autoimmune Hepatitis Test
LKM-1-Ab ELISA
New
Automatic Hematology Analyzer
LABAS F9000
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








DIASOURCE (A Biovendor Company)

Channels

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: An “evolutionary” approach to treating metastatic breast cancer could allow therapy choices to be adapted as patients’ cancer changes (Photo courtesy of 123RF)

Evolutionary Clinical Trial to Identify Novel Biomarker-Driven Therapies for Metastatic Breast Cancer

Metastatic breast cancer, which occurs when cancer spreads from the breast to other parts of the body, is one of the most difficult cancers to treat. Nearly 90% of patients with metastatic cancer will... Read more

Pathology

view channel
Image: A real-time trial has shown that AI could speed cancer care (Photo courtesy of Campanella, et al., Nature Medicine)

AI Accurately Predicts Genetic Mutations from Routine Pathology Slides for Faster Cancer Care

Current cancer treatment decisions are often guided by genetic testing, which can be expensive, time-consuming, and not always available at leading hospitals. For patients with lung adenocarcinoma, a critical... Read more

Technology

view channel
Image: Researchers Dr. Lee Eun Sook and Dr. Lee Jinhyung examine the imprinting equipment used for nanodisk synthesis (Photo courtesy of KRISS)

Multifunctional Nanomaterial Simultaneously Performs Cancer Diagnosis, Treatment, and Immune Activation

Cancer treatments, including surgery, radiation therapy, and chemotherapy, have significant limitations. These treatments not only target cancerous areas but also damage healthy tissues, causing side effects... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.