5 Key Takeaways

• 1

  The FDA granted 510(k) clearance for Hologic’s Aptima SARS-CoV-2 assay, originally authorized in May 2020.

• 2

  The assay detects SARS-CoV-2 RNA and can process over 1,000 tests per day, remaining widely used in clinical practice.

• 3

  The Aptima assay is validated for nasopharyngeal and nasal swab specimens from symptomatic patients, offering a less invasive option.

• 4

  The assay uses Hologic’s transcription-mediated amplification chemistry for sensitive detection and is processed on the Panther system.

• 5

  Hologic has secured additional FDA clearances for respiratory diagnostic assays, enhancing capabilities for respiratory pathogen detection.