{"id":814082,"date":"2025-02-18T08:19:12","date_gmt":"2025-02-18T13:19:12","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-announces-fda-clearance-of-aptima-sars-cov-2-assay\/"},"modified":"2025-02-18T08:19:12","modified_gmt":"2025-02-18T13:19:12","slug":"hologic-announces-fda-clearance-of-aptima-sars-cov-2-assay","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/hologic-announces-fda-clearance-of-aptima-sars-cov-2-assay\/","title":{"rendered":"Hologic Announces FDA Clearance of Aptima SARS-CoV-2 Assay"},"content":{"rendered":"

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Hologic Announces FDA Clearance of Aptima SARS-CoV-2 Assay<\/b><\/p>\n

MARLBOROUGH, Mass.–(BUSINESS WIRE<\/a>)–
\nHologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company\u2019s Aptima\u00ae SARS-CoV-2 assay, which was first granted Emergency Use Authorization (EUA) status in May 2020.\n<\/p>\n

\n\u201cOur COVID test was instrumental in addressing critical testing needs during the pandemic and offered healthcare providers and laboratories a solution that was highly sensitive and able to help mitigate outbreaks. Nearly five years after the beginning of the pandemic, the test is still widely used,\u201d said Hologic Diagnostic Solutions President Jennifer Schneiders, Ph.D. \u201cWith the virus now in an endemic state, full FDA clearance will give laboratories and clinicians peace of mind that they can continue to rely on the test to make informed decisions about patient treatment and the management of healthcare resources.\u201d\n<\/p>\n

\nThe Aptima SARS-CoV-2 Assay is an in vitro<\/i> diagnostic test that detects SARS-CoV-2 RNA from nasopharyngeal (NP) or nasal swab samples obtained from people exhibiting signs and symptoms of a respiratory tract infection. The nasal swab allows for a simpler, less invasive alternative to NP swab collection, which must be performed by a healthcare practitioner. The nasal swab is minimally inserted into the nostril entrance, which reduces patient discomfort, pain and anxiety during testing compared to the original NP swab method, which is inserted deep into the nasal cavity.\n<\/p>\n

\nThe test uses Hologic\u2019s transcription-mediated amplification (TMA) chemistry, which can detect and quantify genetic sequences to determine the presence of respiratory viral pathogens.\n<\/p>\n

\nSamples are processed on Hologic\u2019s Panther\u00ae system, which is used in labs across the U.S. and around the world. Each Panther can provide initial results in less than three hours and process more than 1,000 tests in a 24-hour period. Customers may add a Panther Fusion\u00ae module to expand their respiratory testing offerings with the Panther Fusion respiratory assays.\n<\/p>\n

\nFDA clearance for Aptima SARS-CoV-2 underscores Hologic\u2019s commitment to emergency preparedness and respiratory diagnostic solutions. In addition to the Aptima SARS-CoV-2 assay, Hologic recently received FDA clearance for several other respiratory tests that detect SARS-CoV-2:\n<\/p>\n