On Mar. 5, 2020, Hologic announced a molecular assay for detecting the novel coronavirus SARS-CoV-2 (previously 2019-nCoV) on the automated Panther Fusion system  developed by investigators at Hannover Medical School in Germany. The preclinical assay was described online in the Journal of Clinical Virology.

The Open Access™ functionality on the Panther Fusion® system allows accredited medical laboratories to design and validate laboratory developed tests (LDTs) to run on the fully automated, high-throughput platform. Laboratories can run their LDTs simultaneously with commercially available CE-IVD assays in a random access model, without waiting to batch tests.

Users of Open Access are required to follow all applicable local requirements for their laboratory and users in developing and validating their own LDTs on the Panther Fusion system.

The Panther system launched in Europe in 2010 and in the U.S. in 2012. The Panther Fusion module, which was launched in Europe in 2016, can be attached to existing Panther systems in the field to extend testing capabilities.

Specifically, the Panther Fusion module adds the capacity to run PCR assays and the Open Access functionality allows labs to develop LDTs using the platform.