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

Download Mobile App





Applied BioCode SARS-CoV-2 Assay Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 19 Jun 2020
Applied BioCode, Inc. More...
(Santa Fe Springs, CA, USA) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its BioCode SARS-CoV-2 Assay.

BioCode SARS-CoV-2 Assay is a CLIA high-complexity multiplex nucleic acid assay for the qualitative detection of SARS-CoV-2 nucleic acids in respiratory samples, including nasopharyngeal swabs, nasal swabs, oropharyngeal swabs and bronchoalveolar lavage, from individuals who are suspected of COVID-19 by their healthcare provider. It is designed to detect two different regions of the SARS-CoV-2 virus N gene which are also utilized by the CDC EUA assay.

The assay runs on the BioCode MDx-3000, an automated molecular diagnostic system. BioCode SARS-CoV-2 Assay can deliver up to 564 sample results in a day (188 sample results in an eight-hour shift) to help address COVID-19 testing needs. The assay can be run as an independent assay or in parallel with our FDA-cleared BioCode Respiratory Pathogen Panel for a more complete respiratory infection profile of patients.

"We are extremely pleased to provide our BioCode SARS-CoV-2 Assay with the high throughput automated MDx-3000 system to help with the fight against the COVID-19 pandemic,” said Dr. Winston Ho, Ph.D., Applied BioCode’s President. “Our automated assays can provide CLIA high complexity laboratories with the capability to perform high throughput, efficient testing to meet testing needs. Furthermore, our multiplex BioCode Respiratory Pathogen Panel offers comprehensive tests combined with flexible ordering and reporting capabilities. We are very proud of our company’s ability to respond to this crisis and are committed to provide sensitive and reliable diagnostic information to laboratorians to better manage their patients.”

Related Links:
Applied BioCode, Inc.


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)
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
Anti-Thyroid Peroxidase Assay
LIAISON Anti-TPO
New
PSA Assay
CanAg PSA EIA
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: A simple blood test could replace surgical biopsies for early detecion of heart transplant rejection (Photo courtesy of Shutterstock)

Blood Test Detects Organ Rejection in Heart Transplant Patients

Following a heart transplant, patients are required to undergo surgical biopsies so that physicians can assess the possibility of organ rejection. Rejection happens when the recipient’s immune system identifies... Read more

Pathology

view channel
These images illustrate how precision oncology Organ Chips recapitulate individual patients’ responses to chemotherapy (Photo courtesy of Wyss Institute at Harvard University)

Cancer Chip Accurately Predicts Patient-Specific Chemotherapy Response

Esophageal adenocarcinoma (EAC), one of the two primary types of esophageal cancer, ranks as the sixth leading cause of cancer-related deaths worldwide and currently lacks effective targeted therapies.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.