Hologic wins CE Mark for Panther Fusion MRSA assay

Hologic (NSDQ:HOLX) said today that its Panther Fusion MRSA assay won CE Mark clearance in the E.U.

The company’s MRSA assay can detect and differentiate between Staphylococcus aureus and methicillin-resistant Staphylococcus aureus in ESwab nasal samples. The test is the latest in Hologic’s portfolio of Panther Fusion and Aptima assays.

With the company’s Panther Fusion system, laboratories can run up to 32 different assays at the same time. MRSA samples can be loaded directly into the Panther Fusion system and labs can expect the test’s results in 2.4 hours, according to Hologic. The Panther Fusion system enables the lab to process up to 500 assays in an 8-hour period, the company added.

Panther Fusion is available as a standalone system or as a module that can attach to existing Panther systems. The module allows labs to run PCR assays in addition to tests based on transcription-mediated amplification, Hologic said.

“The launch of the Panther Fusion MRSA assay demonstrates our commitment to expanding the portfolio of assays available for Panther Fusion, enabling our European customers to deliver a better service to their clients and ultimately to patients,” João Malagueira, VP of diagnostics for Hologic’s EMEA unit, said in prepared remarks.

“With rising antibiotic resistance in Europe and the threat posed by healthcare-associated infections to public health, our new assay will help customers provide a rapid service to hospitals, so cases of resistance, such as MRSA, are identified and managed quickly and effectively,” Malagueira added.

HOLX shares were trading at $39.72 apiece in mid-morning activity today, up 0.5%.

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