Abbott lands FDA EUA for first commercial monkeypox test

The diagnostic response to monkeypox has happened in two waves. First, a set of laboratories, including Quest and Labcorp, began processing samples using a test developed at the Centers for Disease Control and Prevention. Now, with the Department of Health and Human Services opening up the EUA pathway, a new set of tests are coming to market.

Abbott is the first company to make a test available commercially via the EUA route. All the steps needed to run the test, such as sample preparation and PCR assembly, are performed automatically by Abbott’s Alinity m System. Abbott designed the system to increase the throughput of infectious disease testing.

To validate the monkeypox test, Abbott performed a clinical evaluation study. The study assessed the ability of the test to correctly identify the presence of monkeypox virus at two and four times the limit of detection. Alinity m MPXV detected the virus in all 36 positive samples. The test also correctly reported that the virus was absent from 35 negative samples.

Other companies are working to join Abbott on the market. Last month, Becton Dickinson outlined plans to file for EUA of a PCR test that runs on its BD MAX machines. BD has already made the test available for research use. The activity follows a summer in which physicians said the expansion of the types of test, plus improved access to testing, would help the response against the pathogen.

Dive brief:

• Abbott Laboratories has become the first company to win emergency use authorization for a commercial monkeypox test kit.
• The Food and Drug Administration granted the EUA to the real-time polymerase chain reaction (PCR) test Alinity m MPXV after reviewing the results of a study of 36 contrived clinical samples.
• Quest Diagnostics received EUA for its monkeypox test last month, becoming the first company with an authorized test against the pathogen, but its assay is not available commercially.

MedTech Dive