Hologic Launches Second High-Throughput Molecular Assay for Novel Coronavirus

Hologic, Inc. (Marlborough, MA, USA) has launched a new Aptima molecular assay to detect the SARS-CoV-2 virus that can be used by labs for clinical testing on the company’s Panther system after completing performance verification testing.

Hologic has begun distributing a Research Use Only (RUO) version of the Aptima SARS-CoV-2 test to hospital, public health and reference laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. Hologic has also applied apply for Emergency Use Authorization (EUA) for the Aptima SARS-CoV-2 assay from the US Food and Drug Administration and plans to register a CE Mark for diagnostic use in Europe later in May.

The Aptima SARS-CoV-2 assay runs on the Panther system, a fully automated, high-throughput molecular diagnostic platform which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in a 24-hour period. More than 1,800 Panther systems are installed in 60 countries and over 1,000 instruments are installed across all 50 states in the US. Combining the world’s largest installed base of high-throughput molecular instruments with significant manufacturing capacity for the new test is expected to dramatically increase testing capabilities for the novel coronavirus.

Hologic expects to provide its laboratory customers approximately three million RUO tests initially. Starting in late May, the company expects to begin producing at least one million Aptima SARS-CoV-2 assays per week on average. Hologic is also planning to increase its production capacity further in the coming months. Because Hologic’s supply chain has been geared to produce tens of millions of Aptima tests annually for other infectious diseases, the company can redirect these manufacturing resources to produce large quantities of coronavirus assays. Additionally, the use of Hologic’s Aptima assays do not require additional sample preparation steps or commercial reagents from other vendors, which is expected to help reduce competition for raw materials and increase global testing capacity. In order to help alleviate shortages of commonly used sample collection swabs and transport media, Hologic has validated its Aptima Multitest Swab Specimen Collection Kit for testing with both the Aptima and Panther Fusion SARS-CoV-2 assays.

In March 2020, Hologic had received EUA for its first COVID-19 test, the Panther Fusion SARS-CoV-2 assay. The Panther Fusion system, an add-on module to the base Panther platform, uses polymerase chain reaction (PCR) chemistry to perform Hologic’s suite of respiratory assays such as influenza. Laboratories can use the Panther Fusion system to test a single patient sample for SARS-CoV-2 and other respiratory viruses that can cause similar symptoms, increasing efficiency and clinical insight.

“Our second COVID-19 test leverages the same proprietary Aptima chemistry and Panther instrumentation that have made Hologic a leader in molecular diagnostics for other infectious diseases,” said Steve MacMillan, the Company’s Chairman, President and CEO. “The ability to deliver test results when and where they are needed -- so people can either get back to work or quarantine themselves -- has emerged as a key to re-opening global economies. We are responding to this need by developing a second test that can be produced in much larger quantities than our first, and run on a much larger installed base of instruments.”