Hologic Announces FDA Clearance of Aptima SARS-CoV-2 Assay
Hologic (NASDAQ: HOLX) has received FDA 510(k) clearance for its Aptima SARS-CoV-2 assay, upgrading from its previous Emergency Use Authorization (EUA) status granted in May 2020. The test detects SARS-CoV-2 RNA from nasopharyngeal or nasal swab samples, offering a less invasive testing option through nasal swabs.
The assay utilizes Hologic's transcription-mediated amplification (TMA) chemistry and runs on the Panther system, capable of processing over 1,000 tests daily with initial results in under three hours. The company has also secured FDA clearances for several other respiratory tests, including the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay for various sample types.
Hologic (NASDAQ: HOLX) ha ricevuto l'approvazione 510(k) dalla FDA per il suo test Aptima SARS-CoV-2, passando dallo stato di Autorizzazione all'Uso di Emergenza (EUA) ottenuto a maggio 2020. Il test rileva l'RNA del SARS-CoV-2 da campioni di tampone nasofaringeo o nasale, offrendo un'opzione di test meno invasiva tramite tamponi nasali.
Il test utilizza la chimica di amplificazione mediata da trascrizione (TMA) di Hologic e funziona sul sistema Panther, capace di elaborare oltre 1.000 test al giorno con risultati iniziali in meno di tre ore. L'azienda ha anche ottenuto approvazioni FDA per diversi altri test respiratori, incluso il test Panther Fusion SARS-CoV-2/Flu A/B/RSV per vari tipi di campioni.
Hologic (NASDAQ: HOLX) ha recibido la aprobación 510(k) de la FDA para su prueba Aptima SARS-CoV-2, mejorando su estado anterior de Autorización de Uso de Emergencia (EUA) concedido en mayo de 2020. La prueba detecta RNA del SARS-CoV-2 a partir de muestras de hisopos nasofaríngeos o nasales, ofreciendo una opción de prueba menos invasiva a través de hisopos nasales.
La prueba utiliza la química de amplificación mediada por transcripción (TMA) de Hologic y se ejecuta en el sistema Panther, capaz de procesar más de 1,000 pruebas diarias con resultados iniciales en menos de tres horas. La empresa también ha asegurado aprobaciones de la FDA para varias otras pruebas respiratorias, incluyendo la prueba Panther Fusion SARS-CoV-2/Flu A/B/RSV para varios tipos de muestras.
홀로직 (NASDAQ: HOLX)는 압티마 SARS-CoV-2 검사에 대해 FDA 510(k) 승인을 받았으며, 이는 2020년 5월에 부여된 긴급 사용 승인(EUA) 상태에서 업그레이드된 것입니다. 이 검사는 비인두 또는 비강 면봉 샘플에서 SARS-CoV-2 RNA를 감지하여 비강 면봉을 통한 덜 침습적인 검사 옵션을 제공합니다.
이 검사는 홀로직의 전사 매개 증폭(TMA) 화학을 사용하며, 팬서 시스템에서 작동하여 하루에 1,000건 이상의 검사를 처리할 수 있으며 초기 결과를 3시간 이내에 제공합니다. 회사는 또한 다양한 샘플 유형에 대해 팬서 퓨전 SARS-CoV-2/독감 A/B/RSV 검사를 포함한 여러 호흡기 검사에 대한 FDA 승인을 확보했습니다.
Hologic (NASDAQ: HOLX) a reçu l'approbation 510(k) de la FDA pour son test Aptima SARS-CoV-2, passant de son statut précédent d'Autorisation d'Urgence (EUA) accordée en mai 2020. Le test détecte l'ARN du SARS-CoV-2 à partir d'échantillons d'écouvillons nasopharyngés ou nasaux, offrant une option de test moins invasive grâce aux écouvillons nasaux.
Le test utilise la chimie d'amplification médiée par transcription (TMA) de Hologic et fonctionne sur le système Panther, capable de traiter plus de 1 000 tests par jour avec des résultats initiaux en moins de trois heures. L'entreprise a également obtenu des autorisations de la FDA pour plusieurs autres tests respiratoires, y compris le test Panther Fusion SARS-CoV-2/Grippe A/B/RSV pour divers types d'échantillons.
Hologic (NASDAQ: HOLX) hat von der FDA die 510(k)-Zulassung für seinen Aptima SARS-CoV-2-Test erhalten, der von dem zuvor im Mai 2020 erteilten Notfallgenehmigungsstatus (EUA) aufgewertet wurde. Der Test erkennt SARS-CoV-2-RNA aus nasopharyngealen oder nasalen Abstrichproben und bietet eine weniger invasive Testoption durch nasale Abstriche.
Der Test nutzt die von Hologic entwickelte transkriptionell vermittelte Amplifikation (TMA) Chemie und läuft auf dem Panther-System, das in der Lage ist, täglich über 1.000 Tests durchzuführen und erste Ergebnisse in weniger als drei Stunden zu liefern. Das Unternehmen hat auch FDA-Zulassungen für mehrere andere Atemwegstests erhalten, einschließlich des Panther Fusion SARS-CoV-2/Grippe A/B/RSV-Tests für verschiedene Probenarten.
- FDA 510(k) clearance upgrade from EUA status enhances product legitimacy
- Test processes over 1,000 samples in 24 hours with results in under 3 hours
- Offers less invasive nasal swab testing option alongside traditional nasopharyngeal method
- Recent FDA clearances for multiple respiratory testing products demonstrate portfolio expansion
- None.
Insights
The FDA's full 510(k) clearance for Hologic's Aptima SARS-CoV-2 assay marks a important transition from Emergency Use Authorization status, solidifying the company's position in the $7.1 billion global COVID-19 diagnostics market. This regulatory milestone carries several strategic advantages:
The clearance creates a significant competitive moat, as full FDA approval requires more rigorous validation than EUA status. This positions Hologic advantageously against competitors still operating under EUA. The company's expanding respiratory diagnostic portfolio, with multiple FDA-cleared tests for SARS-CoV-2, Flu, and RSV, demonstrates a comprehensive market approach that addresses various testing needs.
The Panther system's high-throughput capabilities (1,000+ tests per day) and rapid turnaround time (under 3 hours) provide a compelling value proposition for clinical laboratories. The platform's versatility in handling multiple assay types creates recurring revenue opportunities through reagent sales and potential system upgrades via the Panther Fusion module.
Federal funding support through BARDA indicates government confidence in Hologic's technology and suggests potential future contracts for emergency preparedness. This relationship could prove valuable as healthcare systems maintain vigilance against emerging respiratory threats.
The test's less invasive nasal swab collection method addresses important market demands for patient comfort and simplified sample collection, potentially driving broader adoption in various healthcare settings. This feature, combined with the test's high sensitivity and automated processing, positions Hologic to capture market share in both acute care and routine screening applications.
“Our 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,” said Hologic Diagnostic Solutions President Jennifer Schneiders, Ph.D. “With 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.”
The Aptima SARS-CoV-2 Assay is an in vitro 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.
The test uses Hologic’s transcription-mediated amplification (TMA) chemistry, which can detect and quantify genetic sequences to determine the presence of respiratory viral pathogens.
Samples are processed on Hologic’s Panther® system, which is used in labs across the
FDA clearance for Aptima SARS-CoV-2 underscores Hologic’s 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:
- In May 2023, the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay received FDA clearance for use with nasopharyngeal samples.
- In July 2024, The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay received FDA clearance for use with anterior nasal swabs.
- In November 2024, the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay was expanded for use with anterior nasal swabs transported via enhanced specimen transport media (eSTM).
Development of the Aptima SARS-CoV-2 assay was funded in whole or in part with federal funds from the
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 testing for women’s health, sexually transmitted infections, respiratory infections, viral load, transplant viruses and other infectious diseases, 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.
About Hologic, Inc.
Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. For more information on Hologic, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube.
Hologic, The Science of Sure, Aptima, Open Access, Panther and Panther Fusion are all registered trademarks of Hologic, Inc. and/or its subsidiaries in
SOURCE: Hologic, Inc.
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Media Contact
Bridget Perry
Senior Director, Corporate Communications
(+1) 508.263.8654
bridget.perry@hologic.com
Investor Contact
Michael Watts
Corporate Vice President, Investor Relations
(+1) 858.410.8514
michael.watts@hologic.com
Source: Hologic, Inc.
FAQ
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