Cue Health Receives FDA Emergency Use Authorization for Molecular Mpox Test

Tuesday, March 21, 2023

Cue Health, a healthcare technology company, today announced it has received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for its molecular test to detect the mpox virus (formerly known as monkeypox). This nucleic acid amplification test (NAAT) is run on a Cue Reader, can be performed at any CLIA-waived facility and delivers results in 25 minutes, significantly expanding access to fast and accurate testing for patients.

This EUA marks an important milestone for Cue Health, as it is the company’s first non-COVID test to receive FDA authorization, as well as its initial offering in the sexual health category for point-of-care diagnostics. The authorization demonstrates the diverse applications of the Cue Health Monitoring System, proving its capability to address a wide range of testing needs.

Like all tests developed by Cue, the Cue Mpox Molecular Test was designed with ease-of-use in mind. The test simply requires using a Cue Sample Wand to collect a lesion sample or to dip into a viral transport medium (VTM) containing a specimen. The Cue Sample Wand is then inserted into the Cue Cartridge, which has been placed inside the Cue Reader. Results are delivered to a mobile device in 25 minutes. The test demonstrated high accuracy in trials, achieving 100% concordance with the CDC’s mpox test on the clinical samples tested.

‟At Cue, we are committed to developing innovative diagnostic solutions that empower both patients and healthcare providers with accurate and timely results,” said Ayub Khattak, CEO of Cue Health. ‟The FDA EUA for our Mpox Molecular Test provides a great tool for clinicians and their patients and demonstrates our platform's versatility.”

Mpox is a highly contagious and potentially severe viral infection that has recently emerged as a global health concern. With symptoms ranging from fever and fatigue to severe skin eruptions and respiratory distress, early and accurate detection of mpox is crucial in controlling its spread and providing timely medical intervention.

With a diverse suite of tests utilizing the same diagnostics platform currently under FDA review and in development, Cue Health continues to innovate and expand its product offerings. Cue's first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription. The company has since submitted an application to the FDA for an EUA for its Cue Flu + COVID-19 Molecular Test. In addition, Cue’s standalone molecular tests for both flu and COVID-19 are under de novo review with the FDA for full clearance. Cue also expects to submit its RSV, strep throat, and chlamydia + gonorrhea multiplex tests to the FDA for review later this year. With an installed base of more than a quarter million Cue Readers, Cue’s COVID-19 test has been used by millions of Americans and has become a go-to solution for accuracy, speed, and convenience.



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