Local biotech firm Cue Health Inc. (NASDAQ: HLTH) announced it’s been awarded a $28 million federal contract to develop a Flu A/B, RSV, and COVID-19 molecular multiplex test for over-the-counter and point-of-care use. In only 25 minutes, the technology would detect influenza A, influenza B, respiratory syncytial virus (RSV), and COVID-19 simultaneously, and connect results to smart devices. There are no tests like this currently available to consumers over-the-counter, says Cue Health.
“[These] are common respiratory viruses that can be serious, especially for older adults, those with weakened immune systems and young children,” Cue Health Chief Medical Officer Dr. David Tsay said. “Combined, these viruses are responsible for hundreds of thousands of hospitalizations each year in the U.S. This test will provide timely differential diagnosis, which is critical because the viruses present many of the same symptoms but are treated differently. For example, influenza and COVID-19 can be treated with distinct FDA-authorized antiviral medications, which must be administered soon after infection to be the most effective.”
Cue Health believes that eliminating testing redundancies will ultimately save time and cut down on healthcare costs. “If approved, [this] can be used in healthcare settings and at home, in the workplace, at schools, senior citizen centers, as well as other congregate settings,” Tsay said.
History of Federal Support
The contract comes from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services (HHS).
“BARDA is on the frontlines protecting Americans from current and future public health threats, and through our five-year partnership, we are leveraging our diagnostic expertise and innovative molecular technology to support HHS in this important endeavor,” Tsay said. “Respiratory viruses continue to pose risks to tens of millions of Americans each year, but through collaborations such as this one, we can arm individuals and their providers with the tools they need that lead to better health outcomes.”
Cue Health’s last awarded BARDA contract was in 2020, when BARDA helped fund Cue’s efforts to accelerate the development, validation and FDA clearance of its COVID-19 test. It was the first molecular test to receive FDA Emergency Use Authorization for at-home and over-the-counter use without a prescription.
Landmark Industry Milestone
This June, the company received what it calls a landmark industry milestone after being granted De Novo authorization from the FDA for its COVID-19 test – the first of its kind to be granted for any home-use respiratory test available without a prescription. For background, the FDA De Novo pathway helps to authorize novel, low to moderate-risk medical devices.
“We believe our De Novo authorization is a very positive signal for our molecular test submissions already under FDA review and the others we have forthcoming,” Tsay explained.
This year, the company’s first non-COVID test was granted FDA authorization. Developers created a molecular monkeypox test that can be taken at specialized clinical testing facilities. Results become available in 25 minutes.
Lab and Pharmacy Services
As the world continues to embrace telemedicine, the team recently launched what it’s calling Cue Lab and Cue Pharmacy. The lab offers a suite of at-home diagnostic test kits.
“These easy-to-use kits provide individuals with access to accurate, reliable testing from the comfort of their own homes, making it easier for people to take control of their health,” Tsay said. “The tests are integrated into Cue Care – our innovative test-to-treat service, which allows individuals to access tests, telehealth, and treatment, including e-prescriptions and medication delivery, from the privacy of home.”
The pharmacy offers over-the-counter and prescription medication for everything from erectile dysfunction and herpes to birth control and hair loss.
“Many of the conditions for which we now offer care choices and medication often go ignored or unaddressed due to a gap in awareness or a lack of discreet access, which can lead to adverse health effects,” Tsay added.
Cue Health announced in August that revenue was $9.9 million for the second quarter of 2023, with $7.6 million from the private sector. It expects third quarter 2023 revenues in the range of $11 million to $13 million.
CEO: Ayub Khattak
HEADQUARTERS: Sorrento Valley
NOTABLE: In January, Scripps Research Translational Institute partnered with Cue Health to launch ImmunoCARE, a remote trial to reduce hospitalizations in immunocompromised people infected with SARS-CoV-2.