Diagnostic testing at the speed of life

Ayub Khattak

Problem Tech Solves

Cue’s mission is to enable personalized, proactive and informed healthcare that empowers people to live their healthiest lives. Approximately 70% of all clinical decisions are made utilizing diagnostic data. In order to live their healthiest lives, people need health data that is accessible, actionable and available when and where they need it most. We believe we are leading a digital transformation revolution to address this, starting with diagnostics – the one area of healthcare that shapes the clinical decisions and courses of care for millions of patients. We are building a new healthcare model – one that is designed to be convenient, connected and consumer centric. We plan to enable end-to-end care journeys from diagnostic tests – lab-quality tests with results delivered in minutes – anywhere and anytime – to physician consultation via telemedicine through intervention. We aim to empower people by making it incredibly simple to get information about their health. Our first commercially available test, the Cue COVID-19 Test, delivers on this vision. It is the first FDA-approved molecular diagnostic test available to consumers in the U.S. without a prescription. Cue’s test offers convenience, privacy, safety and the ability to test frequently, with the accuracy of a centralized lab test.

Tech Brief

The Cue Health Monitoring System is a portable, intuitive, fast, accurate and connected system that delivers test results to a connected mobile device in about 20 minutes. It is a lab in the palm of your hand. Our first commercially available product, the Cue COVID-19 Test, detects the RNA of SARS-CoV-2, the virus that causes COVID-19, with the accuracy of a central lab test. It is a highly sensitive and specific nucleic acid amplification test (NAAT) that runs on the rechargeable, reusable Cue Cartridge Reader, a device which fits in the palm of your hand. Results are displayed directly onto the user’s mobile smart device via the Cue Health App. Each Cue Test Cartridge Pack includes the single-use, self-contained Cue Test Cartridge and the Cue Sample Wand, which is the swab for minimally invasive sample collection. Together, these components make up the Cue Health Monitoring System to offer clinical-grade performance at home or in a non-clinical setting. The accuracy of our test was confirmed by a recent independent study, conducted by researchers at the Mayo Clinic, that found that the overall concordance between our COVID-19 test and clinical laboratory tests using NAAT was 97.8%.

Tech Differentiators

Over the last 10 years, we created everything we do at Cue to deliver a great experience for consumers. From how we designed the Cue Health Monitoring System, which fits in the palm of your hand, to the fully guided app, our packaging and everything in between. And we are aiming to make it accessible wherever a person is: at home, at work, or at the point-of-care. We envision that people will have access to Cue through their employers, healthcare providers, payors and – and ultimately, direct to them as consumers. Cue’s success during the COVID-19 pandemic revealed the speed and value of our distinctive platform, but even more, it showed the potential of what could be ahead: the consumer power that will come when a smarter, faster and more accessible diagnostic platform is applied all across healthcare. It is clear that the status quo in healthcare does not work. We believe healthcare is ready for a simple, convenient and digital approach for empowering each person. Ultimately, we believe this is how you make big change in the world – by giving people health data that is accessible, actionable and available when they need it. By starting with the individual. By remembering that healthcare is always personal.


We believe the power of our platform has been demonstrated by our substantial growth, the quality of our customers, the clinical validation and two regulatory authorizations received, including being the first company to have a product authorized by the FDA for molecular-based infectious disease testing available for home use. Specific examples of success include: - Our $481 million DoD/HHS contract to deploy six million COVID-19 tests across 10 U.S. states - Partnerships with Mayo Clinic and Children’s Hospital of Philadelphia (CHOP) - Serving as an official point-of-care test for the NBA 2020 restart - The independent clinical validation study by Mayo Clinic finding the overall concordance between our COVID-19 test and clinical laboratory tests using NAAT was 97.8%. Our partners agree: - “Cue’s COVID-19 Test is an efficient solution at the point of care and is a critical part of our strategy to deliver the right test, for the right person, at the right time.” – Admiral Brett P. Giroir, Former Assistant Secretary for Health - “There is something unique this year in that those dog teams will be out there—magical in a primal way—but only so because of best-in-class testing.” – Rob Urbach, Iditarod Chief Executive - “[Cue Tests] were invaluable at the most desperate time … I would say it was an instrumental tool in protecting the food supply and saving lives.” – Dr. Ann Jarris, Discovery Health MD CEO - “We can’t get enough of it… We have huge demand for the test, our customers absolutely love it.” – Bruce Lieberthal, Henry Schein Chief Innovation Officer

Why Us

We are making diagnostic testing accessible, fast, accurate and easy to use, putting the consumer in control of their health data. Our COVID-19 test is just the beginning. We envision tests to address respiratory health, sexual health, cardiac and metabolic health, women's health, men's health, and chronic disease management.

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