FDA Issues EUA for Cue Health’s Molecular Diagnostic Monkeypox Virus Test


Authorized for use in professional point-of-care settings, the nucleic acid amplification diagnostic tool delivers results in 25 minutes.

Monkeypox virus is a smallpox-like viral infection transmitted from animals to humans | Image Credit: AGPhotography - stock.adobe.com

AGPhotography - stock.adobe.com

The FDA has issued an emergency use authorization (EUA) for a molecular test by Cue Health to detect the monkeypox (Mpox) virus.1

The nucleic acid amplification test is run on a Cue Reader, which can be performed at any clinical laboratory improvement amendments-waived facility. The test can deliver results in 25 minutes, expanding access to accurate and fast testing.1

“At Cue, we are committed to developing innovative diagnostic solutions that empower both patients and health care providers with accurate and timely results,” Ayub Khattak, CEO of Cue Health, said in a statement. “The FDA EUA for our Mpox Molecular Test provides a great tool for clinicians and their patients and demonstrates our platform's versatility.”1

The Cue Mpox Molecular Test was designed to be used with ease, requiring a Cue Sample Wand to collect a lesion sample or dip into a viral transport medium that contains a specimen.1

The Cue Sample Wand gets inserted into the Cue Cartridge, which is inside the Cue Reader. The results are delivered to a mobile device.1

The test demonstrated high accuracy in clinical trials, achieving 100% concordance with the CDC’s Mpox test on the clinical samples tested.1

Cue Health previously developed a COVID-19 test, which was the first FDA-authorized molecular diagnostic test for at-home and OTC use without a prescription.

The company has also submitted an application to the FDA for an EUA for its Cue Flue + COVID-19 Molecular Test.1

Additionally, Cue has 2 tests for both COVID-19 and influenza that are under de novo review with the FDA for full clearance. The company is also expected to submit its chlamydia and gonorrhea, respiratory syncytial virus, and strep throat multiplex tests to the FDA for review later this year.1

The EUA marks the company’s first non-COVID-19-related test to received FDA authorization.1

As of March 15, 2023, there had been a total of 30,262 cases of Mpox in the United States and a total of 38 deaths.2

Symptoms of Mpox usually occur within 3 weeks of exposure to the virus, with the infection lasting from 2 to 4 weeks, typically. Symptoms often include backaches; chills; exhaustion; fever; headaches; muscle aches; a rash on the chest, face, feet, genitals, hands, or mouth; respiratory symptoms; and swollen lymph nodes.3

Mpox typically presents with flu-like symptoms first, with a rash developing 1 to 4 days later. The rash goes through several stages, which includes scabs, before it begins to heal. It can look like blistering or pimples and can become itchy or painful.3

Some individuals may not experience all symptoms, with some only experiencing flu-like symptoms, only a rash, or a combination of both.3


1. Cue Health receives FDA emergency use authorization for molecular Mpox test. March 20, 2023. Accessed March 22, 2023. News release. https://www.businesswire.com/news/home/20230320005260/en

2. 2022 US map & case count. CDC. Updated March 15, 2023. Accessed March 22, 2023. https://www.cdc.gov/poxvirus/mpox/response/2022/us-map.html

3. Mpox: your health. CDC. Updated September 13, 2022. Accessed March 22, 2023. https://www.cdc.gov/poxvirus/mpox/your-health/index.html

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