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





Hologic Granted FDA Emergency Use Authorization for Asymptomatic COVID-19 Testing with Panther Fusion SARS-CoV-2 Assay

By LabMedica International staff writers
Posted on 29 Sep 2020
Hologic, Inc.’s (Marlborough, MA, USA) Panther Fusion SARS-CoV-2 assay has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.

The Panther Fusion SARS-CoV-2 test runs on Hologic’s fully automated Panther Fusion system, which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours. More...
Hologic’s assay is the first widely available, high-throughput molecular diagnostic test specifically authorized for screening asymptomatic people. A recent report published by the FDA compared more than 50 COVID-19 tests and demonstrated that Hologic’s assays are the most analytically sensitive of the fully automated, high-throughput molecular tests on the market. High analytical sensitivity is one of the key characteristics for tests to be used effectively in asymptomatic screening and pooling workflows.

The US Centers for Disease Control and Prevention (CDC) had recently issued guidance recommending COVID-19 tests for people who have had recent contact with infected individuals, a key strategy for limiting the spread of the virus. The Panther Fusion SARS-CoV-2 test is expected to play a key role in identifying early infection in exposed individuals, as well as reopening schools, workplaces and the economy in general.

“Accurately identifying individuals early in the course of infection - so they can quarantine before passing on the virus - is critical to stemming the spread of this pandemic,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “The high accuracy of molecular testing has made it the gold standard for infectious disease detection, and recent data demonstrate that Hologic’s molecular coronavirus tests are among the most sensitive available.”

Related Links:
Hologic, Inc.


Gold Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
Automated PCR Setup
ESTREAM
New
Staining Management Software
DakoLink
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.