Hologic (NSDQ:HOLX) announced late this afternoon that it will launch a second high-throughput molecular diagnostic test for the coronavirus (SARS-CoV-2). Investors reacted by sending shares in HOLX up 8.27% in after-hours trading.
The Marlborough, Mass.-based company said it aims to produce at least 1 million Aptima tests per week to run on more than 1000 of its Panther instruments installed in all 50 states. The U.S. Department of Health and Human Services will provide $13 million to help the company ramp up production through the Biomedical Advanced Research and Development Authority (BARDA).
Next week, Hologic expects to begin distributing a research-use only (RUO) version of its 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. The company also plans to apply for FDA emergency use authorization (EUA) for the test next week and for the CE Mark for diagnostic use in Europe later in May.
Hologic plans to ship approximately 3 million RUO tests initially. Starting in late May, the company expects to begin producing an average of at least 1 million Aptima assays per week and to increase its production capacity further in the coming months.
The company landed an EUA for its first COVID-19 diagnostic in March.
“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 Hologic president & CEO Steve MacMillan in a news release. “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.”
Each Panther system can provide initial results in approximately 3 hours and process more than 1000 coronavirus tests in a 24-hour period, the company noted. Approximately 750 U.S. hospital, public health and reference labs use the Panther system.
Because Hologic’s supply chain has been geared to produce tens of millions of Aptima tests annually for other infectious diseases, the company said it can redirect these manufacturing resources to produce large quantities of coronavirus assays. Also, Hologic said its Aptima assays do not require additional sample preparation steps or commercial reagents from other vendors, which is the company expects to help reduce competition for raw materials and increase global testing capacity.
To help alleviate shortages of commonly used sample collection swabs and transport media, Hologic said has validated a multitest swab specimen collection kit for testing with both the Aptima and Panther Fusion SARS-CoV-2 assays.