Hologic (HOLX) Gets EUA For Its Coronavirus Detecting Test
Zacks Investment Research | Mar 17, 2020 08:13AM ET
Hologic, Inc. (NASDAQ:HOLX) announced the receipt of the FDA’s Emergency Use Authorization (“EUA”) for its latest molecular diagnostic test, Panther Fusion SARS-CoV-2 assay. Notably, the test detects SARS-CoV-2.
Per Hologic, it is the first company to receive support for developing the coronavirus detection test from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (“BARDA”).
With this, Hologic aims to strengthen the foothold in the global Molecular Diagnostics market.
A Peek Into Panther Fusion System
Panther Fusion system is a fully automated high-throughput molecular diagnostic platform, which is widely used across the United States. Notably, the Panther Fusion SARS-CoV-2 assay is a real-time polymerase chain reaction (RT-PCR) in vitro diagnostic test, which is intended to be used for the qualitative detection of RNA from the SARS-CoV-2. The test is done after the collection of swab specimens from patients, who meet the COVID-19 clinical and/or epidemiological criteria.
Regulatory Status of Panther Fusion System
The Panther Fusion SARS-CoV-2 assay has not been cleared or approved by the FDA yet. It has only been authorized by the FDA under a EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments (“CLIA”) to perform high-complexity tests.
The test has been permitted only to be used to detect RNA from SARS-CoV-2 and the diagnosis of SARS-CoV-2 infection. Further, the authorization is only valid for the duration of the declaration that circumstances exist, justifying the authorization of the emergency use of in-vitro diagnostics, for the detection of SARS-CoV-2.
Significance of the Approval
Hologic’s Panther Fusion system can be availed by hospitals, public health organizations and reference laboratories to provide faster results. Notably, the test to detect SARS-CoV-2 can be performed from the same patient sample and collection vial, which is already being used to detect other common respiratory viruses whose symptoms overlap with COVID-19. This can be done through the Panther Fusion system, thus, boosting efficiency and increasing clinical insight.
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Another significant advantage of the use of the system is that patients’ samples can be loaded onto the Panther Fusion system as soon as they arrive in the laboratory. The capability of faster loading of the sample, known as random access, is expected to speed up the testing, and improve efficiency and workflow by the instrument’s high throughput and quick turnaround time.
Industry Prospects
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