Meeting a Public Health Need at the Point-of-Care

This past year, there have been more than 30,000 reported cases of mpox in the U.S. alone, and countless more that have gone undetected. While the medical community has made great strides in managing this public health crisis, including gaining a better understanding of the virus and scaling vaccination efforts to support vulnerable communities, the Centers for Disease Control and Prevention (CDC) recently issued an alert that this summer season could lead to a resurgence of mpox. 

To combat this, the CDC is urging clinicians to be on alert for new cases of the highly contagious disease and, if mpox is suspected, to test — even if a patient previously had mpox or is vaccinated against the disease. 

Due to this public health need, we developed a highly accurate molecular mpox test that can be performed in authorized laboratories or by healthcare professionals in CLIA-certified patient care settings such as a doctor’s office, delivering results in just 25 minutes. In clinical sample testing, the test demonstrated 100% concordance with the FDA-cleared CDC mpox test. The Cue Mpox (Monkeypox) Molecular Test received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) in March, and is now available for professional use in point-of-care settings across the country.  

Enabling the early and accurate detection of the mpox virus is critical to preventing further spread by identifying cases and isolating infected individuals and to providing timely medical intervention. As we have seen with other public health crises, testing helps healthcare professionals to identify emerging hotspots and enables the prioritization of resources to those communities. At an individual level, patients benefit from confirming their status, seeking appropriate care, and thus taking appropriate precautions to prevent further transmission.

At Cue, we envision a world where access to testing and actionable diagnostic data is ubiquitous and convenient for all. The Cue Mpox (Monkeypox) Molecular Test launch is one more step towards that world. Our work here is focused on making that vision a reality, by developing and offering a diagnostic-led healthcare ecosystem that provides a seamless experience from testing to treatment.