This story has been updated with news about Cue's partnership with Major League Baseball.
NEW YORK – Six months after going public, Cue Health has revealed its plans for further test menu expansion of its flagship Cue Reader instrument, as well as for market growth in both the US and internationally.
During a conference call to discuss the firm's Q4 and full-year 2021 financial results, Cue CEO and Cofounder Ayub Khattak laid out the company's road map for the rest of the year, detailing planned regulatory submissions and clinical studies for some of the new tests in Cue's pipeline.
Currently, the firm offers its Cue Health Monitoring System, which includes the Cue Reader and COVID-19 test kit and is authorized for use at the point of care and at home, but it intends to bulk up that menu with cardiometabolic tests, assays for sexual health, and respiratory disease tests, among others. It also has virtual care offerings and other software components.
The firm's regulatory plans start with the COVID-19 test, which received Emergency Use Authorization from the US Food and Drug Administration for point-of-care settings and CLIA-certified labs in June 2020 and later garnered EUA for home and over-the-counter use in March 2021. Khattak said on the call that the company completed enrollment in a clinical study of the test for 510(k) clearance from the FDA in February and plans to submit to the agency for review in Q2.
Khattak noted that the company also has an Omicron-specific COVID-19 test under review with the FDA right now, which it submitted to the agency for EUA on March 3. The assay is able to detect both the BA1 and BA2 subvariants of Omicron and could be useful in helping clinicians decide which therapies to use, as some are less effective with different SARS-CoV-2 variants and subvariants, he said.
Next on the docket is the firm's influenza A/B test, which it expects to submit for FDA clearance in Q3, Khattak said. The firm will continue to enroll patients in studies for that test throughout the second quarter of 2022, although it anticipates using some banked samples as part of the submission, due to the less severe respiratory season, Khattak said.
A multiplex COVID-19 and influenza test is in late-stage technical development, he added, and can detect and differentiate flu from COVID-19. The firm is continuing to optimize the test's performance and expects clinical studies for it to begin in the second half of the year, he said. Khattak noted that there is an EUA pathway available to Cue for the multiplex test, which could simplify the clinical and regulatory processes.
The firm's test for respiratory syncytial virus is also in late-stage development, and Khattak said the company expects clinical studies to begin in Q3.
Beyond respiratory diseases, Cue also has a multiplex sexual health test for chlamydia and gonorrhea in the works, with clinical studies planned for the second half of the year.
One test is not being prioritized over the other, he noted, and Cue helped identify which sets of assays were particularly important — for respiratory and sexual health — by which one had treatments available. These test categories fit "in this really important model of going from diagnosis to talking to a doctor to getting the treatment," he said. Almost all of the diseases addressed by Cue's upcoming tests have treatments available, he added.
Although he didn't specify where in the development process other tests are, Khattak noted the firm has plans for cardiometabolic tests, chronic disease management tests, and tests for women's and men's health. Each of the tests in development will be able to run on the Cue Reader, he said. According to the company's 10-K form filed with the US Securities and Exchange Commission, Cue also considers tests for fertility, pregnancy, and inflammation to be in late-stage technical development.
"Menu expansion is proceeding at a very fast clip, and we have a robust set of tests showing strong progress that will increase our addressable opportunity," he said.
As the company's test menu expands, Cue is working to grow and diversify its customer base and will be utilizing another distribution channel for its tests: the direct-to-consumer market. The firm launched its DTC offering late last year, along with a monthly subscription model, although some said the subscription plans' prices may be out of the reach of many people. Cue later lowered the cost of both plans, and on the conference call, CFO John Gallagher said that the firm made the move because "it's important to us to make sure Cue is as accessible to as many people that want it as possible," he said.
So far, the company is "very pleased" with the uptake of its DTC offerings, although Gallagher noted that it is still early days.
The firm is "investing heavily in and rapidly building the technology enhancements" for the integrated care platform it offers, Khattak said, including building out integrations with electronic medical record systems for professional users, expanding to international app stores, and streamlining its workflows from diagnosis to prescription delivery — a capability that will soon be available as part of the DTC offering. He also mentioned that the firm is working to enable reimbursement directly on its platform.
The company also has other channels for distribution, including agreements with businesses and sports leagues. On Friday, the firm announced that it is expanding its partnership with Major League Baseball to provide COVID-19 testing to Major League Clubs as well as the MLB league office.
The company is also working on worldwide expansion, with Khattak saying that the firm has already begun commercializing its COVID-19 test and reader in Canada and Singapore. Earlier this month, Cue received interim order authorization from Health Canada to sell its at-home test and reader in the country.
Khattak said that the Canadian commercialization has begun through distributors and businesses in the country, as well as through its DTC option.
In November 2021, the COVID-19 test was authorized for self-testing by the Singapore Health Sciences Authority. Cue has partnered with Singapore laboratory supplier Omnicell Pte to distribute its tests in the country. The firm also received CE marking for its COVID-19 test in December 2020 and approval from India's Central Drugs Standard Control Organization for professional point-of-care use in June 2021, according to its 10-K form.
Part of the appeal of ex-US growth is the need to mitigate the seasonality of its products, Khattak said, particularly in the respiratory market, and Cue wants "to be in different countries to mitigate that demand pattern," including countries in the Southern Hemisphere where the major respiratory illness season occurs during the US' summer.
In addition, international expansion is consistent with Cue's "value proposition … of how we want to deliver healthcare," Khattak said. "We think that the need is consistent globally, meaning everybody wants to have accurate diagnostics that they could leverage to have a more meaningful virtual care conversation and then ultimately get treatment," he said.
Distribution in the US has expanded as well, with Cue inking distribution agreements with Cardinal Health for both healthcare providers and home users and with McKesson, Medline, and Henry Schein for healthcare providers. A new partnership with grocery company Albertsons, announced last week, will put Cue's tests in more than 900 pharmacies across the US for use at the point of care. That partnership will drive increased access to Cue's tests, especially in communities that may not have access to molecular diagnostic lab testing, Khattak said.
The firm also fulfilled its contract with the US Department of Defense during the fourth quarter, distributing 6 million test cartridges and 30,000 readers via the agency to underserved communities in 18 states, he said. Cue is also continuing conversations with the DoD to utilize the agency's broad installed base to get its products to more customers.
Khattak further noted that Cue was recently awarded an indefinite delivery, indefinite quantity contract for up to $50 million from the Defense Logistics Agency to facilitate the acquisition of Cue products for any federal agencies.
Gallagher said that with the completion of the DoD contract, the company has created a large installed base of its instruments within the public sector and is "seeing the right demand signals coming in" from states interested in its products, although he said that it is still early and "takes time to have direct engagement with these states."