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FDA clears Hologic’s Aptima SARS-CoV-2 assay - MSNThese include the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay for use with nasopharyngeal samples in May 2023. In November 2024, it was expanded for use with anterior nasal swabs transported ...
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Hologic, Inc. (HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Aptima® SARS-CoV-2 ...
Hologic, Inc. HOLX recently expanded its Global Access Initiative (“GAI”) with the addition of the Aptima SARS-CoV-2 assay. The GAI’s all-inclusive pricing structure is anticipated to make ...
The Panther Fusion ® SARS-CoV-2/Flu A/B/RSV assay is a real-time PCR test, while the Aptima® SARS-CoV-2 assay utilizes Hologic’s proprietary TMA ® technology.
Hologic has also received data from clinical users in Europe indicating that the Aptima SARS-CoV-2 assay detected Omicron COVID-19 infections in samples from inbound air travelers.
In January 2022, Hologic announced the addition of the Aptima SARS-CoV-2 assay to its Global Access Initiative (GAI), a program designed to expand access to critical diagnostic testing in resource ...
Hologic, Inc.’s HOLX Aptima SARS-CoV-2 molecular diagnostic test recently got CE marking for its use with saliva sample. This assay, which runs on fully automated Panther system, detects the ...
Hologic, Inc. HOLX recently expanded its Global Access Initiative (“GAI”) with the addition of the Aptima SARS-CoV-2 assay. The GAI’s all-inclusive pricing structure is anticipated to make ...
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