Cue Health
OTCPK:HLTH.Q
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End-of-day quote: 03/20/2026
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Cue Health Company Info
EPS Growth 5Y
-39,05%
Market Cap
$0,00 B
Long-Term Debt
$0,00 B
Short Interest
0,00%
Annual earnings
N/A
Dividend
$0,00
Dividend Yield
0,00%
Founded
2010
Industry
Country
ISIN Number
Website
Analyst Price Target
The Analyst Price Target shows the analysts’ low, high, and average target at a glance.
There are currently no price targets available for this stock.
In the last five quarters, Cue Health’s Price Target has risen from $0,50 to $0,50 - a 0,00% increase.
Top growth stocks in the health care sector (5Y.)
What does Cue Health do?
Cue Health Inc. operates as a health technology company.
The company seeks to usher in a new era in healthcare, what the company calls Healthcare 2.0, to transform how acute and chronic conditions are diagnosed and managed.
The company is helping pioneer this healthcare digital transformation, beginning with diagnostics. The company started from consumer-centric principles and designed the company’s proprietary platform, the Cue Integrated Care Platform, with a relentless focus on user experie...
Cue Health Inc. operates as a health technology company.
The company seeks to usher in a new era in healthcare, what the company calls Healthcare 2.0, to transform how acute and chronic conditions are diagnosed and managed.
The company is helping pioneer this healthcare digital transformation, beginning with diagnostics. The company started from consumer-centric principles and designed the company’s proprietary platform, the Cue Integrated Care Platform, with a relentless focus on user experience, convenience, and accuracy, with the goal of enabling people to make quicker, better-informed healthcare decisions. The Cue Integrated Care Platform consists of multiple hardware, software, and diagnostic components: (1) the company’s revolutionary, proprietary Cue Health Monitoring System, made up of a portable, durable and reusable reader, or Cue Reader; a single-use test cartridge, or Cue Cartridge; and a sample collection wand, or Cue Wand; (2) the company’s Cue Data and Innovation Layer, with cloud-based data and analytics capabilities; (3) the company’s Cue Virtual Care Delivery Apps, including the company’s consumer-friendly Cue Health App, the clinician-facing Cue Clinic, and the company’s Cue Enterprise Dashboard; and (4) the company’s Cue Ecosystem Integrations and Apps, including integration with: electronic medical record, or EMR, systems (enabling seamless connection between a clinician, their EMR, and Cue’s diagnostics); pharmacies and last-mile delivery (enabling electronic prescription, or e-Rx, and on-demand delivery), clinician networks (enabling virtual care and prescription), and laboratories (enabling mail-in panel testing).
The company’s platform has been designed to work seamlessly to deliver and manage health data both within the healthcare system and within the home. Through the company’s application programming interfaces, or APIs, the company’s platform has been engineered so that it can be directly integrated into existing workflows and on-demand services, such as telemedicine, e-Rx services, and EMR systems. For example, the company implemented an integration with one of the U.S.’s leading EMR systems on behalf of one of the company’s customers, a leading healthcare system, to enable a seamless workflow from test ordering to test results, with the company’s mobile app and the Cue Health Monitoring System. But beyond designing the company’s platform to be able to integrate within the traditional healthcare system, the company has built its platform to enable fast, frequent, lab-quality diagnostics by anyone, anywhere, intended to facilitate a new continuous care model of personalized and contextualized healthcare. The company’s first commercially available diagnostic test for use with the company’s Cue Health Monitoring System is the company’s Cue COVID-19 Test Kit, which has received De Novo authorization, as well as two Emergency Use Authorizations, or EUAs, from the U.S. Food & Drug Administration, or the FDA, for point-of-care and over-the-counter and at-home use, an Interim Order authorization from Health Canada, regulatory approval from the Central Drugs Standard Control Organisation (‘CDSCO’), and authorization from Singapore Health Sciences Authority. Users can run a COVID-19 test anywhere using the Cue Reader and a Cue COVID-19 Test Kit, and have lab-quality test results delivered digitally to the user’s mobile smart device in about 20 minutes.
The launch of Cue Care marks the full realization of the Cue Integrated Care Platform: empowering individuals to test themselves from the comfort of their homes, consult with a clinician in real-time, and receive treatment within a matter of hours. This represents a fundamental principal for the future of healthcare. When the company launched Cue Care in August 2022, users could connect with a virtual care provider within the Cue Health App about their COVID-19 test results. If medically indicated, that user could receive an e-prescription for anti-viral medication, which could then be delivered the same day. Soon after the initial launch of Cue Care, the company expanded the Cue Care experience to allow users to upload any COVID-19 test result (including non-Cue test results, such as from an antigen test) and third-party urinary tract infection and influenza test results to go through the same virtual care and e-prescription process.
In February 2023, the company further expanded its Cue Care capabilities and the company’s product line by launching Cue Lab at-home test kits, allowing users to test for certain general health and wellness conditions, making it easier for people to take control of their health using actionable information. Through this feature, individuals with a wide range of health concerns, such as sexual health, heart health, and food sensitivities, can order an at-home panel test kit through the Cue Health App or on the company’s website, receive one or more sample collection kits, collect their sample, and mail their sample to one of the company’s independent, CLIA-certified, diagnostic lab partners using an enclosed, self-addressed stamped envelope. After processing by the lab, the user’s easy-to-understand results are securely delivered back to the customer in the Cue Health App, along with educational materials about their condition or concern. The user can then choose to consult virtually with a healthcare provider via Cue Care to receive personalized care and treatment delivered quickly.
In May 2023, the company announced an expansion of its Cue Integrated Care Platform to include a new pharmacy offering (Cue Pharmacy) with over-the-counter and prescription medication options for a growing number of common health and wellness needs. These include sexual health, such as erectile dysfunction and herpes, as well as birth control, hair loss, and more.
While the company’s at-home test kits and other Cue Health App features allow users to access a greater variety of tests and information about their health, the company continues to develop its own test kits for use with the Cue Health Monitoring System. The company’s COVID-19 test and mpox test (authorized under EUA), are the company’s only commercially available test kits for use with the company’s Cue Reader, and the company’s future tests remain subject to technical development, clinical studies and regulatory authorization, clearance or approval, the company has additional test kits that are under review by the FDA (Flu de novo, RSV de novo). The company also has test kits in late-stage technical development (Strep Throat and Chlamydia + Gonorrhea, (swab collection method), Chlamydia + Gonorrhea (urine collection method) and HSV 1/2 + Mpox molecular multiplex test). In August 2023, the company was awarded a new contract to develop an Influenza A/B, RSV, and COVID-19 molecular multiplex test for both over-the-counter and point-of-care use.
The company’s intention has always been to build a broad platform that would reinvent how the company interacts with its health. Since the company’s early days, the company developed its platform to be able to address the majority of diagnostic tests routinely conducted in clinical laboratories because users will not only demand a simple, personalized, convenient and connected solution but also a single platform to address their healthcare needs. The company’s focus is on creating experiences with the user at the center, enabling high satisfaction, measurable health outcomes, and more cost-effective care for the entire ecosystem.
The company’s platform will allow the company to continue to develop and commercialize new tests quickly and scale rapidly, driven by the company’s flexible technology and its in-house, vertically-integrated and automated manufacturing facilities. The company’s platform has the potential to perform a variety of different tests by accommodating different sample types, including saliva, blood, and urine, detecting nucleic acids, small molecules, and proteins or cells. Because the company developed its manufacturing facilities and processes in tandem with the company’s technology, the company was able to scale its production using fully automated production pods. A production pod is a free standing, modular environmentally-controlled structure containing an automated test cartridge production line. Additionally, the company produces its critical biochemistry in-house, including enzymes, antibodies and primers for the company’s Cue Cartridges. For the year ended December 31, 2023, one customer accounted for 57% of the company’s total product revenue.
Solution
The company’s Cue Integrated Care Platform is simple, fast, and accurate. The company’s Platform is designed to harness the power of the cloud and provide consumers and enterprises with real-time access to their data and the broader healthcare ecosystem as part of the company’s planned end-to-end solution. Development of the Cue Integrated Care Platform is guided by the company’s focus on the user, whether that be a clinician in a provider office or an individual at home, with a simple goal of enabling users to have reliable information at their fingertips to make faster and more informed healthcare decisions and receive the treatment they need when they need it most. The Cue Integrated Care Platform consists of the following hardware and software components.
Cue Health Monitoring System
The Cue Health Monitoring System consists of the company’s Cue Reader and a Cue Test Kit. Each Cue Test Kit is consisted of a Cue Cartridge and a Cue Wand. The Cue Reader is an elegantly designed, automated analyzer of test results and is used with Cue Test Kits and the Cue Health App. The Cue Reader contains all the circuitry necessary to process, analyze, and communicate test results digitally, including encrypted Bluetooth radio communication and other sensors. The Cue Reader runs the Cue Cartridge and communicates the result of the test digitally via Bluetooth to the Cue Health App. The Cue Reader is easy to set-up and use and is designed to be universally compatible with the company’s Cue Test Kits. The Cue Cartridge is a sample-specific, single-use cartridge designed to handle different chemistries. Each Cue Cartridge contains the specific reagents and associated materials required to detect the target of the particular test and is designed with ease-of-use, user safety, and scalability in mind. The Cue Wand is a single-use and sterile sample collection device designed to permit collection of multiple sample types, including saliva, blood, and urine, with only minor modification. When a Cue Wand is inserted into the associated Cue Cartridge, the system automatically runs the test and delivers the result to the company’s Cue Health App.
Cue Data and Innovation Layer
The company’s cloud-native Cue Data and Innovation Layer stores and curates the data from the company’s Cue Health Monitoring System and provides a secure environment for users to access current and historical health data. The company’s Data and Innovation Layer has the ability to collate unstructured and structured data from a wide variety of data sources, including data from Cue’s mail-in test kits, which gives the company the ability to store and analyze more holistic sets of health data, including from other testing modalities and wearables. The Cue Data and Innovation Layer provides the foundation for the company’s Cue Virtual Care Delivery Apps and has enabled the development of the company’s Cue Ecosystem Integrations and Apps. The Cue Data and Innovation Layer contains an API that allows for the data from tests performed on the Cue Health Monitoring System to be received, stored, and retrieved by the end user and for mail-in test kit results to be received on the Cue Health App. For enterprises deploying the Cue Enterprise Dashboard, the Cue Data and Innovation Layer enables the creation of a network of users affiliated by roles with the enterprise. Within this network of users, the Cue Data and Innovation Layer provides the engine behind test analytics, creation of groups, scheduling and compliance, reporting, and enterprise-specific privacy policy management. The Cue Data and Innovation Layer powers the EMR integration with major EMR providers.
Cue Virtual Care Delivery Apps and Cue Care
The company’s Cue Virtual Care Delivery Apps consist of the Cue Health App, Cue Clinic, and the Cue Enterprise Dashboard. Together, the Cue Health App and Cue Clinic are the two front-end applications that comprise Cue Care. Cue Care is the marketed term for the combination of virtual care delivery apps (the consumer-facing Cue Health App and the clinician-facing Cue Clinic app), services and integrations that power the clinician-consumer interactions such as video calls, secure messaging, prescription ordering, test ordering, and medication delivery. As most healthcare journeys begin with diagnosis, the Cue Health App first provides the interface to run a Cue Test Kit on the Cue Reader or to receive results of a mail-in, at-home test. The Cue Health App creates a secure interface between the user and their health data. For consumers, it allows a single point of entry for their health data and to receive virtual care and treatment. For healthcare professionals, Cue Clinic is designed to provide a unified platform for managing patient histories and allows for telemedicine and e-prescription services through the Cue Ecosystem of Integration and Apps.
The Cue Enterprise Dashboard is designed to allow enterprises, payors, healthcare providers and public health entities to manage population health at the organizational level and has the potential to track the efficiency of various population health programs. Accessible online, the Cue Enterprise Dashboard has the potential to help organizations manage a patient’s journey from onboarding to scheduling, care management and inventory management. Powered by the company’s analytics engine and role-based access capabilities, it is designed to provide chief medical officers, environmental health and safety officials, and benefits managers with insight into their organization’s population health, helping to facilitate decision making.
Cue Ecosystem Integrations and Apps
By securely connecting the company’s Cue Data and Innovation Layer with on-demand services, such as telemedicine and e-prescription services, and integrating with wearable technology, the company will enable a truly digital and seamless user experience. In the future, the company plans on enhancing its platform to enable additional third-party application development and offerings that complement the company’s solutions. In addition, the company’s ability to integrate with anchor EMR systems, such as Epic Systems Corporation, or Epic, allows the company’s customers to integrate the company’s platform with their existing systems, creating an agile and responsive workflow for patient monitoring for ongoing care, better intelligence and reporting, and more efficient provider-level health management.
Underlying Diagnostic Technology for Cue Test Kits
Once a test sample is collected via the Cue Wand and inserted into the Cue Cartridge, the test automatically begins. Depending on the type of Cue Cartridge, the company’s platform uses either a nucleic acid amplification tests (‘NAAT’) or immunoassay to perform a test. In both cases, an internal or process control confirms proper assay execution, including as relevant, sample analysis, amplification, sample flow and assay reagent function. Once the assay begins, all heating, mixing, amplification and detection takes place within the Cue Cartridge with no steps by the user. The Cue Reader then communicates the test result digitally, directly, and wirelessly to the Cue Virtual Care Delivery Apps.
Testing Technologies
Molecular Tests
Molecular tests, also known as NAAT, target genetic material (DNA or RNA) in order to detect a broad range of infectious diseases, and are considered to be the most reliable for this purpose. Polymerase Chain Reaction (‘PCR’) and isothermal amplification are two types of molecular testing techniques. The Centers for Disease Control, or CDC, has described molecular tests as the ‘gold standard’ for clinical diagnostic detection of COVID-19. The company’s COVID-19 Test Kit was the first molecular diagnostic test authorized for at-home and over-the-counter use without physician supervision or a prescription. For infectious diseases, molecular tests are more sensitive than antigen tests and have been recommended by the CDC as the preferred testing technology.
Immunoassay Tests
Immunoassays are widely used in clinical care. In clinical laboratories, the most common immunoassay technique is the Enzyme Linked Immunosorbent Assay, or ELISA, which is a fundamental clinical diagnostic methodology for detecting and quantifying a wide range of analytes and is one of the main modern lab techniques employed by central labs for a variety of clinical applications. The company’s ability to perform ELISA-like chemistry within the same cartridge structure the company uses to run its molecular tests enables the company to detect and quantify the biomarkers necessary to expand the company’s care offerings for use cases, including in cardiometabolic health (cholesterol, inflammation, HbA1c), men’s health (testosterone, prostate specific antigen), women’s health (pregnancy, fertility), other cardiac care (troponin, brain natriuretic peptide), wellness (vitamin D), and other tests.
Strategic Collaborations and Certain Other Agreements
Th U.S. Government
BARDA
The company has partnered with the U.S. Biomedical Advanced Research and Development Authority, or BARDA, since June 2018, initially focusing on a molecular influenza test using the Cue Health Monitoring System pursuant to a contract that was originally effective through January 2021. In March 2020, BARDA exercised an option to accelerate development, validation and FDA clearance of the company’s COVID-19 test. In May 2020, the company’s original contract with BARDA was amended to extend the contract term to January 2023. Pursuant to the company’s agreement with BARDA, the company agreed to provide regular reports to BARDA regarding its progress and certain customary oversight provisions. Furthermore, in January 2022, the scope of the company’s partnership with BARDA was increased to include the company’s development of an Omicron-Genotyping COVID-19 test to be used in professional point-of-care settings. In December 2022, the existing contract was further amended to extend the period of performance to June 2023, and has since subsequently been modified to extend the period of performance to September 2024.
In August 2023, the company was awarded a new contract by BARDA to develop an Influenza A/B, RSV, and COVID-19 molecular multiplex test for both over-the-counter and point-of-care use.
Minnesota Department of Health
In December 2022, the company had been selected by Minnesota Department of Health (MDH) to provide a statewide COVID-19 telehealth to treatment program, powered by Cue Care, at no cost to Minnesota residents. Through this program, Minnesotans who test positive for COVID-19 on any self test can consult virtually with a healthcare professional through the Cue Care platform to obtain a prescription for COVID-19 treatment, if medically indicated, and at no cost to that individual. The COVID-19 treatment can be made available for same-day pick-up or delivery. Minnesotans can access Cue Care for this service via a mobile smart device, web, or telephone, which allows for greater access to care. In February 2023, the contract was extended through June 2024.
Google
In April 2021, the company entered into an agreement with Google LLC to provide Cue Readers and Cue COVID-19 Test Kits to Google's employees through year end 2021. In November 2021, this agreement was renewed through June 30, 2022. Under the renewed agreement, Google’s employees were given access to proctoring services. In June 2022 the contract was renewed through December 31, 2022 and in December 2022, it was renewed through June 30, 2023 and subsequently extended through December 31, 2024.
In August 2021, the company entered into a partnership with Google Cloud to accelerate the development of a secure real-time COVID-19 variant tracking and sequencing solution. The partnership is intended to create an advanced respiratory biothreat detection system spanning from the company’s at-home diagnostic testing to full real-time viral sequencing, as well as analytical and predictive capability using Google Cloud powered solutions.
Growth Strategy
The key elements of the company’s growth strategy are to expand its menu of tests and continue to innovate and enhance the company’s platform; continuing to expand the company’s installed base and distribution network to enable pull-through of the company’s future extended care offerings; driving ecosystem adoption; increase adoption through value-based selling and payor reimbursement; continue to build the Cue brand; and expand the company’s global footprint.
Clinical Results
Mayo Study
In January 2021, Mayo Clinic Laboratories published the results of an independent clinical validation study that evaluated the clinical performance of the company’s COVID-19 test in Diagnostic Microbiology & Infection Disease, a leading peer-reviewed scientific and medical journal in the fields of clinical microbiology and the diagnosis and treatment of infectious diseases. The study was performed using lower nasal swabs and the results were compared to a reference central laboratory NAAT in 292 symptomatic and asymptomatic adults who were referred for COVID-19 testing in a community drive though collection setting operated by the Mayo Clinic. The study protocol was approved by the Mayo Clinical Institutional Review Board. The samples were collected in August 2020. Patient health status was not collected at the time of testing. The study concluded that Cue COVID-19 test was both sensitive and specific compared to central laboratory testing and that the Cue COVID-19 test for SARS-CoV-2 can be considered a feasible solution to implement at sites requiring a point-of-care solution.
The reference panel testing of 206 patients was conducted using the Hologic Aptima SARS-CoV-2 assay on a Hologic Panther instrument and the reference panel testing of 85 patients was conducted using the Mayo Clinic laboratory for testing by a RT-PCR testing on the Roche Light Cycle 480. The primary outcome was positive and negative percent agreement between the Cue COVID-19 test and the laboratory tests. The Mayo Clinic used a tie-breaker method for any sample with positive result by the laboratory test but a negative test result by the Cue COVID-19 test. If the patient had received testing by more than one reference method within 14 days of study enrollment, the tie-breaker system referred the reference result to be the result obtained by two of the three methods (Cue, Hologic Aptima and laboratory-development RT-PCR). The study did not have a method for resolving all discrepant results observed and an incorrect reference method result cannot be ruled out. It was also not possible to perform a formal limit of detection study due to the design of the assay at that time. Invalid or cancelled results were not able to be retested as directed by the instructions in the Cue COVID-19 test because study participants left the facility before point-of-care testing was completed.
The Mayo Clinic study concluded that the Cue COVID-19 Test Kit using a lower nasal swab collection method is accurate and is both sensitive and specific compared to central laboratory testing using an NPS collection. Additionally, the study noted the Cue COVID-19 Test Kit is easy to use with minimal training or previous laboratory testing experience.
In March 2021, the FDA issued an EUA for the Cue COVID-19 Test Kit for at-home and over-the-counter use without a prescription or physician supervision, making it the first molecular diagnostic test to receive such authorization. In September 2020, the FDA required the company to evaluate the analytical limit of detection and to assess the traceability of the company’s COVID-19 test with FDA reference materials. Between December 2020 and February 2021, the company conducted prospective studies at four urgent care locations and at two of the company’s own locations to evaluate the use of the Cue COVID-19 Test Kit for at-home and over-the-counter use by lay users in a simulated home use environment. Adult lay users (=18 years of age) self-collected or collected from their child (<18 years of age) a Cue Wand nasal swab and ran the test. Adult and child subjects were enrolled in an ‘all comers’ style at the urgent care locations. A total of 286 subjects were enrolled: 276 adults self-swabbing and self-testing to run the Cue COVID-19 Test Kit for at-home and over-the-counter use and 10 children where their parent collected the nasal sample and ran the Cue COVID-19 Test Kit.
There were 38 subjects who tested positive for COVID-19, 233 subjects who tested negative for COVID-19 and 2 subjects with inconclusive results by the FDA Emergency Use Authorized molecular comparator method. Among the subjects, 10 subjects were asymptomatic positive, 123 subjects were asymptomatic negative, and 1 subject was asymptomatic inconclusive by the comparator. In this clinical study, the company’s COVID-19 test correctly identified 96% (27/28) of positive samples from individuals known to have symptoms and correctly identified 100% (10/10) of positive samples from individuals without symptoms. The company’s COVID-19 test correctly identified 99.1% (231/233) of negative samples. Additionally, in September 2020, the company submitted a post-market clinical data report to the FDA as required under the company’s EUA, which included results from the Mayo Clinic's evaluation of Cue versus an institutional reference panel.
FH Health Study
In October 2023, the company announced the peer-reviewed publication of an independent clinical study, the largest of its kind on asymptomatic people, finding that Cue’s molecular COVID-19 test provides comparable accuracy to centralized lab-based RT-PCR with the advantages of convenient use at the point-of-care or home settings and fast results in 20 minutes.
Regulatory Status
In March 2023, the FDA issued an EUA for the company’s molecular test to detect the mpox virus for use in a point-of-care setting.
In June 2023, the company received De Novo authorization for its molecular test to detect COVID-19.
In December 2023, the company received a response letter from the FDA regarding the EUA submission for the company’s Flu A/B + COVID-19 molecular test for over the counter and point of care use. The letter indicates that the FDA has determined that further review of Cue’s EUA request is not a priority, and therefore declines to issue an EUA for the product at this time. The letter states that the decision is based on review of the submission thus far, including significant issues identified, FDA priorities relating to the COVID-19 testing landscape, and the anticipated FDA resources needed to continue review of the EUA request. The FDA’s determination does not preclude the company’s submission of a future, new EUA request for the company’s Flu A/B + COVID-19 molecular test.
The company has filed De Novo submission to the FDA for full clearance of its Flu A/B standalone molecular test and the company’s RSV molecular tests.
Marketing
The company’s marketing strategy is focused on continuing to build strong brand awareness for the Cue Integrated Care Platform as a next-generation healthcare solution, with relevant, measurable value for all of the company’s customer segments. The company’s marketing drives across its owned media channels (website and social networks), press releases, scientific publications, industry engagement with key stakeholders, partnerships with key opinion and market leaders, and targeted marketing through digital and non-digital channels. The company anticipates using targeted strategies to accelerate brand awareness and increase demand, and thus sales opportunities, across the company’s targeted markets.
Sales
The company’s direct sales team engages with prospective clients and seeks to identify the best sales channel based on each client’s needs. The company’s go-to-market strategy is focused on allowing the company access to the end user, through its Cue Integrated Care Platform, even if the individual was acquired via the company’s direct sales organization or through an outside sales channel. For example, if an individual obtained a Cue Health Monitoring System through their self-insured employer's COVID-19 return-to-work efforts or as a result of government-supported distribution, the company can nonetheless directly engage with the end user through the Cue Health App and potentially convert them to using the company’s at-home, mail-in test kits, as well as planned future Cue Test Kits, lifestyle medications, and other products the company may develop. As a result, the company expects that it will be able to fulfill market demand through the company’s internal and external sales channels, while maintaining an important direct relationship for the company’s product enhancements and care offerings.
The company’s targeted customer segments represent the following four categories:
Enterprise Sales: The company’s enterprise sales strategy identifies major self-insured enterprises, such as Fortune 500 companies with large-covered employee populations, as well as small to medium sized businesses with healthcare plans partners and employee benefits offerings. Enterprise customers will want to utilize the company’s integrated care solutions for their employees and their families, both on-premise and at-home.
Healthcare Provider Sales: The company’s healthcare provider sales strategy targets major healthcare systems and healthcare professionals such as hospital systems, private clinics and concierge health systems, and physicians’ offices. Relationships with the company’s customers help validate its platform, and will help accelerate marketplace adoption of the company’s products. The company’s products are available direct or through major healthcare distributors, including Cardinal, McKesson, Henry Schein, and Medline.
Direct-to-Consumer Sales: The company’s direct-to-consumer sales strategy identifies opportunities through online and offline retail channels such as e-commerce and future opportunities for in-store sales.
Public Sector Sales: The company’s public sector sales strategy identifies new opportunities within federal, state and local government agencies. While the company expects that revenue from other categories of customers will become a larger component of revenue over time, the company’s public sector sales strategy continues to look to identify opportunities with new and existing federal, state and local government agency customers.
Vertically-Integrated Manufacturing Solutions
The company’s manufacturing facilities were developed alongside the company’s science and technology and are vertically-integrated, fully automated and scalable. The company’s integrated manufacturing and bioproduction gives the company completes control over the quality of the company’s finished product.
The company owns and controls the intellectual property that makes the platform possible. The company’s manufacturing process is replicable, and its manufacturing production pods are expected to produce the company’s planned future test menu. The company’s manufacturing capabilities are differentiated and allow the company not only to scale quickly and efficiently, but also to adapt the company’s production quickly to market demands or evolving consumer needs.
The company produces its Cue Cartridges in-house, including critical enzymes, antibodies, and primers for the test cartridges. The company has complete production oversight and quality control over finished products and insulation from global fluctuations in supply chain and costs. The company achieve this by manufacturing all of its Cue Cartridges in the company’s facilities in San Diego, California using its modular, scalable production pods. The company’s fully automated production pods build raw components into fully assembled, packaged cartridges.
The company’s Cue Readers are manufactured by its partners. The company’s Cue Wands are manufactured by the company or its partners. For the company’s Cue Readers and Cue Wands, the company owns and controls all of the intellectual property developed by the company.
Intellectual Property
As of December 31, 2023, the company owned twenty-five (25) issued U.S. utility patents, seven (7) pending U.S. utility patent applications, fifty-eight (58) issued foreign utility patents (including patents in Australia, Canada, China, Hong Kong, India, Israel, Japan, South Africa, South Korea, the United Kingdom, and various European countries), and thirty-five (35) pending foreign utility patent applications (including pending PCT applications).
In addition, the company holds design patents and patent applications that cover various ornamental features of the company’s various current and future Cue products. As of December 31, 2023, the company owned eleven (11) granted U.S. design patents, nine (9) pending U.S. design patent applications, sixty-five (65) granted foreign design patents and design registrations (with protection in Australia, Canada, China, Japan, the United Kingdom, and the European Union, as well as registrations granted through the Hague System for the International Registration of Industrial Designs), and twenty-three (23) pending foreign design applications.
The company’s issued U.S. and foreign utility patents are anticipated to naturally expire between 2034 and 2038, and the company’s U.S. pending utility patent applications and pending PCT applications, if issued into patents, are anticipated to naturally expire between 2034 and 2043, excluding any additional patent term adjustment(s) or extension(s), and assuming payment of all applicable maintenance or annuity fees. The company’s granted U.S. design patents are anticipated to naturally expire between 2029 and 2037. The company’s granted foreign design patents and design registrations are anticipated to naturally expire between 2024 and 2048. Once a patent expires, patent protection ends and an invention enters the public domain allowing anyone to commercially exploit the invention without infringing the patent.
As of December 31, 2023, the company owned seven (7) U.S. trademark registrations, two (2) U.S. trademark applications, forty-eight (48) foreign trademark registrations (including registrations in China, the European Union, Hong Kong, India, Israel, Japan, Mexico, Russia, Singapore, South Korea, and the United Kingdom), and fourteen (14) pending trademark applications (including in Canada, the European Union, India, Mexico and the United Kingdom.
Government Regulation
The company operates under an EUA for an unapproved device to detect the mpox for use in a point-of-care setting, which will remain in effect and terminate on the earlier of a determination that the public health emergency has ceased or a change in the approval status of the company’s product. The company also received an EUA from the FDA on June 10, 2020, as amended on August 20, 2020 and March 26, 2021 (designated as EUA 200248) for the company’s Cue COVID-19 Test Kit for use at the point-of-care with specimens collected using the Cue Wand and for testing of previously collected nasal specimens in viral transport media from individuals who are suspected of having COVID-19 by their healthcare provider. The company received a second EUA from the FDA on March 5, 2021 (designated as EUA Number 210180) for the company’s Cue COVID-19 Test Kit for home and over-the-counter use without a prescription with specimens collected using the Cue Wand from adults or children greater than or equal to two years of age (swabbed by an adult) with or without symptoms or other epidemiological reasons to suspect COVID-19.
In June 2023, the company received a De Novo authorization for its molecular test to detect COVID-19 which had previously been marketed pursuant to the EUA granted on March 5, 2021 (designated as EUA 210180). The company has also filed a De Novo submission to the FDA for full clearance of the company’s Flu A/B standalone molecular test and the company’s RSV molecular tests.
The Cue Health Monitoring system and the company’s Cue COVID-19 Test also are subject to categorization by the FDA pursuant to CLIA and its implementing regulations in the United States which establish quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test is performed.
The company is licensed by the California Department of Public Health as a medical device manufacturer. As a medical device manufacturer, one of the criteria is that the company’s Quality Management System, or QMS, holds an ISO 13485:2016 certificate.
The company is subject to the Open Payments Program. The company is also required to maintain accurate information on and control over sales and distributors’ activities that may fall within the purview of the Foreign Corrupt Practices Act, its books and records provisions and its anti-bribery provisions.
Research and Development
The company’s research and development expenses were $150.6 million for the year ended December 31, 2023.
History
Cue Health Inc. was founded in 2010. The company was incorporated in the state of California in 2010.
This stock is not included in this month's Starter.
The Starter plan only unlocks analyses for the 25 stocks tracked over the past month. With the Compact plan, you get access to all stocks from Germany and the USA – with Premium, worldwide access.
Stock added to your portfolio . To add it to another portfolio, click here.
