Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us

CEPHEID

Develops, manufactures, and markets molecular systems and tests for institutions to perform sophisticated genetic tes... read more Featured Products: More products

Download Mobile App





Cepheid Four-in-One Combination Test for SARS-CoV-2, Flu A, Flu B and RSV Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 28 Sep 2020
Cepheid (Sunnyvale, CA, USA) has been issued an emergency use authorization (EUA) by the US Food and Drug Administration for its four-in-one combination test for SARS-CoV-2, Flu A, Flu B and RSV. More...


The Xpert Xpress SARS-CoV-2/Flu/RSV four-in-one test is expected to deliver qualitative detection of SARS-CoV-2, Flu A, Flu B and RSV from a single patient sample. The regulatory authorization will make the test available globally on its cartridge-based GeneXpert Systems, which features instruments that can be configured for both near patient point-of-care and high volume laboratory testing needs.

The GeneXpert System was built for simple, reference lab quality PCR testing – on location at medical centers and hospitals or closer to patient in health clinics and nursing homes. At the core of every GeneXpert System is the module (or testing bay) where a test cartridge is loaded onto the machine. Cepheid’s line of GeneXpert Systems can be configured with a varying number of modules, or test bays, to meet the volume requirements of any setting. Smaller GeneXpert Systems are configured with two or four modules, meaning up to four different tests can be run at one time. The company’s largest GeneXpert System is configured with up to 80 modules, meaning as many as 80 tests can operate independently at any given time with a capacity of about 2,000 tests per day.

“Leveraging the quality design of Xpert Xpress SARS-CoV-2 and our widely utilized Xpert Xpress Flu/RSV tests, we're combining two world-class products in a single, rapid solution ahead of the upcoming flu season,” said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. “This will enable our customers to have increased testing throughput on their current GeneXpert System and increase our ability to provide supply continuity for the market.”



Gold Member
Universal Transport Solution
Puritan®UniTranz-RT
Portable Electronic Pipette
Mini 96
New
Automatic Chemiluminescence Immunoassay Analyzer
Shine i2000
New
Gold Member
Cardiovascular Risk Test
Metabolic Syndrome Array I & II
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

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 test could streamline clinical decision-making by identifying ideal candidates for immunotherapy upfront (Xiao, Y. et al. Cancer Biology & Medicine July 2025, 20250038)

Blood Test Predicts Immunotherapy Efficacy in Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is an aggressive subtype lacking targeted therapies, making immunotherapy a promising yet unpredictable option. Current biomarkers such as PD-L1 expression or tumor... Read more

Technology

view channel
Image: The sensor can help diagnose diabetes and prediabetes on-site in a few minutes using just a breath sample (Photo courtesy of Larry Cheng/Penn State)

Graphene-Based Sensor Uses Breath Sample to Identify Diabetes and Prediabetes in Minutes

About 37 million U.S. adults live with diabetes, and one in five is unaware of their condition. Diagnosing diabetes often requires blood draws or lab visits, which are costly and inconvenient.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.