As of May 20, 2024, Cue Health has ceased business operations. This decision comes after a year marked by significant financial challenges and a recent inspection by the Food and Drug Administration (FDA) at their San Diego facility on May 9, 2024.

During the inspection, the FDA found Cue had made unauthorized changes to their COVID-19 Tests for Home and Over-the-Counter (OTC) use, as well as their COVID-19 tests for patient point-of-care (POC) settings. With only one product cleared by the FDA, these findings posed a significant issue for Cue Health. A few days later, the FDA issued an online notice advising home test users, caregivers, and healthcare providers to stop using Cue’s COVID-19 tests due to a higher risk of inaccurate results.

How Does AscencioDx Measure Up?

The AscencioDx® measures up quite well to Cue Health when you compare its technology, benefits, and pricing. Both systems involve reverse transcription in-vitro amplification techniques used to produce thousands of copies of DNA and are classified as Nucleic Acid Amplification Tests (NAATs).

The AscencioDx® testing system uses RT-LAMP for the qualitative detection of RNA from the COVID-19 virus in samples that are heated and illuminated (via fluorescence signals) in a reaction tube placed within the detector. For added assurance, the detector includes an internal control on every test sample to confirm test function. This patent-pending design features built-in target redundancy, detecting three distinct regions of the SARS-CoV-2 viral genome, making it highly robust against mutations at any single n-gene location.

In genomic sequence testing, the AscencioDx® COVID-19 Test assay covers 99.99% of all current known variants and sub-variants, such as Omicron. Our R&D team consistently quality-controls our assay against emerging variants to ensure it remains effective and responsive. This dedication to maintaining high standards ensures that healthcare providers using the AscencioDx® system can trust its reliability and accuracy.

Advantages of the AscencioDx® System

• Speed and Efficiency: Leveraging RT-LAMP technology, it works faster and more efficiently than traditional RT-PCR methods.

• Robustness: The built-in target redundancy ensures reliable detection even in the face of viral mutations.

• Comprehensive Coverage: It effectively detects a wide range of COVID-19 variants and sub-variants.

• Quality Assurance: Continuous quality control testing ensures the assay's ongoing responsiveness to new variants.

Additional Benefits

In addition to its affordability and ease of use, the AscencioDx® system also includes a value-added test data management benefit at no extra charge. Anavasi Diagnostics has developed a unique detector portal to help healthcare professionals manage, store, and report patient test results. This system not only provides customizable report templates and one-step features, but it also reduces data entry by populating patient data with the scan of a driver’s license. The secure portal automatically disseminates results to the CDC and other required state and local health agencies through the CDC Report Stream, saving you considerable time.

The AscencioDx® technology is also well-suited for other applications. Consequently, Anavasi is currently developing additional infectious disease assays, including multiplex respiratory Strep-A and sexual health.

Call to Action

As healthcare providers transition away from Cue Health’s products, the AscencioDx® offers a reliable, high-quality alternative that meets the demands of modern diagnostic testing. For more information on how AscencioDx® can benefit your practice, visit our website at www.anavasidx.com or contact our sales team at sales@anavasidx.com. We are committed to supporting you with the highest standards of diagnostic technology.

Resources:

• Calif.-based Cue Health, once worth $2.3 billion, lays off every remaining worker (msn.com)

• FDA Permits Marketing of First COVID-19 At-Home Test Using Traditional Premarket Review Process | FDA

• Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication | FDA

• Form 8-K for CUE Health INC filed 05/28/2024

• Cue Health files for Chapter 7 bankruptcy | LabPulse.com

• Cue Health to cease operations, lay off all employees | LabPulse.com

Where Speed, Efficiency, & Accuracy Align

The AscencioDx® Covid-19 Test and The AscencioDx® Molecular Detector have not been FDA cleared or approved, but have been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.