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
INTEGRA BIOSCIENCES AG

QuidelOrtho

Develops, manufactures and markets rapid diagnostic tests that focus on infectious diseases, reproductive health, and... read more Featured Products: More products

Download Mobile App





Quidel Granted FDA EUA for Lyra Direct SARS-CoV-2 Assay to Allow Direct Sample Processing

By LabMedica International staff writers
Posted on 20 May 2020
Quidel Corporation (San Diego, CA, USA) has received Emergency Use Authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay from the Food and Drug Administration (FDA) to allow direct sample processing.

Under the new EUA, the Lyra Direct SARS-CoV-2 Assay no longer requires an up-front sample extraction. More...
The Lyra Direct SARS-CoV-2 Assay uses a reformulated buffer that replaces the extraction step with a simple 10-minute heat step, saving approximately 50 minutes in processing time. The assay retains its versatility in that it is capable of running on any of seven possible thermocyclers (Applied Biosystems 7500 Standard, Applied Biosystems 7500 Fast, Bio-Rad CFX96 Touch, Qiagen Rotor-Gene Q, Roche LightCycler 480, Roche Cobas z480, and Thermo Fisher QuantStudio 7 Pro).

Separately, the Lyra Direct SARS-CoV-2 Assay received CE Mark on May 8, 2020. The CE Mark allows Quidel to market and sell the Lyra Direct SARS-CoV-2 Assay in Europe, as well as other countries that accept the CE Mark. The assay is currently available for sale in the US under EUA.



Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
POC Helicobacter Pylori Test Kit
Hepy Urease Test
Alcohol Testing Device
Dräger Alcotest 7000
Gold Member
Collection and Transport System
PurSafe Plus®
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: Scout\'s patented molecular technology delivers results matching high-complexity PCR 99% of the time (Photo courtesy of Scout Health)

STI Molecular Test Delivers Rapid POC Results for Treatment Guidance

An affordable, rapid molecular diagnostic for sexually transmitted infections (STIs) has the potential to be globally relevant, particularly in resource-limited settings where rapid, point-of-care results... Read more

Hematology

view channel
Image: Residual leukemia cells may predict long-term survival in acute myeloid leukemia (Photo courtesy of Shutterstock)

MRD Tests Could Predict Survival in Leukemia Patients

Acute myeloid leukemia is an aggressive blood cancer that disrupts normal blood cell production and often relapses even after intensive treatment. Clinicians currently lack early, reliable markers to predict... Read more

Pathology

view channel
Image: Determining EG spiked into medicinal syrups: Zoomed-in images of the pads on the strips are shown. The red boxes show where the blue color on the pad could be seen when visually observed (Arman, B.Y., Legge, I., Walsby-Tickle, J. et al. https://doi.org/10.1038/s41598-025-26670-1)

Rapid Low-Cost Tests Can Prevent Child Deaths from Contaminated Medicinal Syrups

Medicinal syrups contaminated with toxic chemicals have caused the deaths of hundreds of children worldwide, exposing a critical gap in how these products are tested before reaching patients.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.