A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

Hologic Announces FDA Clearance of Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

Multiplexed Respiratory Test Now Available in the U.S. With New RespDirect Collection Kit

What To Know

  • The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay launches with the new RespDirect™ collection kit, which enables laboratories to directly load samples for processing on the Panther Fusion system without any uncapping or specimen transfer steps, saving time and reducing the potential for error, repetitive stress injuries and exposure to viruses.
  • “While we are out of the respiratory virus season this year, accurate viral diagnosis remains a high priority for clinicians for the upcoming respiratory season and we are committed to advancing COVID and respiratory diagnostics on our Panther Fusion system.

Hologic Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay. This assay is a molecular diagnostic test that detects and differentiates four of the most prevalent respiratory viruses that can exhibit similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (flu A), influenza B (flu B) and respiratory syncytial virus (RSV).

“This past winter, we saw several respiratory illnesses — COVID, flu and RSV — spreading simultaneously throughout communities and often presenting with similar symptoms, making diagnoses difficult,” said Hologic Diagnostic Solutions President Jennifer Schneiders, Ph.D. “While we are out of the respiratory virus season this year, accurate viral diagnosis remains a high priority for clinicians for the upcoming respiratory season and we are committed to advancing COVID and respiratory diagnostics on our Panther Fusion system. This test will be a critical tool to help determine which respiratory virus or coinfection patients have so that providers can better inform the best course of treatment.”

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay runs on the fully automated, high-throughput Panther Fusion system, which provides initial results in approximately three hours and can process more than 1,000 tests in 24 hours. The flexible approach of this system, along with Hologic’s respiratory virus menu, offers various testing options from a single sample and allows healthcare professionals and laboratories to personalize patient testing based on medical history and local prevalence.

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay launches with the new RespDirect™ collection kit, which enables laboratories to directly load samples for processing on the Panther Fusion system without any uncapping or specimen transfer steps, saving time and reducing the potential for error, repetitive stress injuries and exposure to viruses.

This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services; the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50121P00022.

Since the beginning of the COVID pandemic, Hologic has shipped more than 200 million SARS-CoV-2 laboratory diagnostic tests worldwide. FDA clearance of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay follows the July 2022 announcement of CE marking for the same test in Europe, furthering Hologic’s position as one of the world’s largest molecular diagnostic companies.

About the Panther and Panther Fusion Systems

The Panther system is a best-in-class, fully automated, sample-to-result molecular diagnostics platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines women’s health, sexually transmitted infection, respiratory infection, viral load, transplant viruses and other infectious disease testing, which can all be done simultaneously. The Panther Fusion module, which is an addition to the Panther system, provides an expanded and growing in vitro diagnostics menu, as well as Open Access™ functionality to run laboratory-developed tests. Learn more about Panther Fusion Respiratory Assays.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The study is designed to assess the clinical utility and workflow benefits of Swoop® system images acquired at infusion centers and clinics to help physicians detect amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients receiving amyloid-targeting therapy at the times specified in the labeling (before the fifth, seventh, and fourteenth infusions).
“Tom and I have more than 50 years of experience,” Harp adds. “The decision to found Polymer Medical was done after careful consideration of the landscape and market opportunity; we will raise the level of competition and quality for customers.” Polymer Medical is located in a newly refurbished plant is at 168 Thorn Ave., Orchard Park, N.Y.
The RWE Program will expand Summus Laser's Class IV Laser Therapy research to generate validated and statistically significant datasets that will be used to enhance patient care, outcomes, and to further product innovations.
Details of the session: Polaroid Therapeutics & Avery Dennison Medical: How the power of partnership brings a novel approach to antimicrobial wound dressings.
SABIC advises the project was initiated together with the dialysis department at Jessa Hospital, one of the largest non-university medical cluster in the Limburg region of Flanders, Belgium.

By using this website you agree to accept Medical Device News Magazine Privacy Policy