Cue Health’s Connected Point-of-Care Covid-19 Test Demonstrates 97.8% Agreement When Compared to Central Lab PCR Testing in an Independent Clinical Validation Study
The study is one of the largest comparisons of a lower nasal swab point-of-care test to nasopharyngeal swab-based central lab PCR tests, in real-world conditions for both symptomatic and asymptomatic subjects
San Diego, CA (February 11, 2021) - Cue Health Inc. (Cue) announced today the results of an independent clinical validation study conducted by Mayo Clinic Laboratories evaluating the accuracy of Cue’s COVID-19 Test in the point-of-care setting against the centralized lab PCR testing model. The study, which was published in Diagnostic Microbiology and Infectious Diseases, included samples from 292 patients at a collection site operated by the Mayo Clinic Health System. The study found that the overall concordance between the Cue point-of-care test and the reference laboratory tests was 97.8%. This is one of the only real-world clinical evaluations to date to compare the accuracy of molecular point-of-care and gold-standard central laboratory tests using samples obtained prospectively from patients, and not using archived or previously tested specimens.
“This study demonstrates the value and accuracy of Cue’s COVID-19 Test as a solution for fast, accurate, molecular testing at point-of-care,” said Ayub Khattak, Founder & CEO of Cue. “A study of this size and scope validates that it is possible to have the accuracy of the best central lab tests with the ease-of-use and speed of a point-of-care test. With many tests coming onto the market, a real-world, independent clinical study like this is valuable to help inform the public and healthcare practitioners about the performance and value of new technologies, and tests for helping to manage the COVID-19 pandemic,” Khattak added.
The study tested a general patient population, and was conducted at a drive-through COVID-19 testing center including both symptomatic patients and asymptomatic patients who had recent exposure to a confirmed SARS-CoV-2 patient. The study found that the overall concordance between Cue Health point-of-care and reference laboratory nucleic acid amplification tests (NAAT) was 97.8%. The Cue Health point-of-care test was positive in 91.7-95.7% of patients who tested positive by the reference method, and 98.4% of patients who received a negative reference result also obtained negative results by Cue Health. Importantly, the evaluation was conducted in a typical point-of-care testing setting using samples obtained prospectively from patients, and not in a central laboratory using archived or previously tested specimens.
Since the COVID-19 pandemic started, the need for rapid and accurate detection of active infection has remained a critical clinical need. Central laboratory methods using NAAT, primarily RT-PCR, take several hours for analytical processing alone. When specimen delivery, sample preparation, and long testing queues are factored in, the total turnaround time using central lab testing is often 24 hours, and can take multiple days or even weeks if samples are sent to a reference laboratory. This extended time to result is not conducive to patient-care and patient triage decisions.
Sample collection can also be a challenge with PCR testing. Specimens taken from the upper respiratory tract using a nasopharyngeal swab are generally accepted as optimal; however it can be unpleasant for the patient. This study shows that Cue’s COVID-19 Test using a lower nasal swab, which allows for a more comfortable patient experience, performs comparably to tests using the nasopharyngeal swab.
Near-patient testing with an accurate testing system can facilitate rapid delivery of actionable diagnostic information, timely care decisions, and infection control. The Cue COVID-19 Test is currently being used across the county in a number of settings including rural communities, congregate care facilities, schools, businesses, walk-in clinics, community testing locations, and more.
About the Cue Health Monitoring System
The Cue Health Monitoring System is a portable, compact, connected diagnostic platform that provides the power of lab-quality molecular testing at point-of-care, when and where it is needed the most. The Cue Health Monitoring system works with the Cue Test Cartridge, the Cue Sample Wand, and the Cue Health App to convert test samples into accurate digital results. The single-use Cue Test Cartridge contains all the biochemistry needed to perform the molecular test. The Cue Sample Wand is a nasal swab supplied with the Cue Test Cartridge. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes via a mobile smart device. The Cue Health App on the user’s mobile smart device is the user interface for test information, instructions, and display of the test results. Designed as a complete diagnostic tool, the Cue Health Monitoring System along with the Cue Test Cartridge and the Cue Health App deliver actionable health data at point-of-care.
COVID-19 Test Cartridge
The Cue COVID-19 Test Cartridge is a single-use, self-contained unit that utilizes proprietary technology to apply the reagents and associated materials required for molecular detection of the SARS-CoV-2 virus, the virus that causes COVID-19. The Cue COVID-19 Test is a high-sensitivity molecular assay that is being deployed to address urgent unmet needs in COVID-19 testing. On June 10, 2020, Cue received Emergency Use Authorization (EUA) from the US Food and Drug Administration for use of the Cue COVID-19 Test Cartridge with the Cue Health Monitoring System to detect nucleic acid from SARS-CoV-2 in nasal specimens from individuals who are suspected of COVID-19 by their healthcare provider.
About Cue Health
Cue Health Inc. (“Cue”) is an ISO 13485-certified company focused on developing and manufacturing professional and consumer medical diagnostic products that can be used in clinical or at-home settings. Cue’s mission is to create tools that empower healthcare providers and consumers by increasing their access to actionable health data. Cue’s first product, the Cue Health Monitoring System with the Cue COVID-19 Test Cartridge, is a platform that provides diagnostic information to clinicians and patients seeking to benefit from a connected healthcare delivery ecosystem. The company is based in San Diego, CA. For more information visit www.cuehealth.com
This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the detection of nucleic acid from SARS CoV-2, not for any other viruses or pathogens; and this test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
February 11, 2021
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