NEW YORK – Bay Area diagnostics firm Lucira Health recently announced preliminary data from a pilot study to assess the performance of an at-home test it has in development for diagnosing Chlamydia trachomatis and Neisseria gonorrhoeae. If commercialized, the assay will mark Lucira's entry into market for at-home diagnostics for sexually transmitted infections.
While the study, undertaken with collaborators at University of California, San Francisco, is ongoing, the company said that its test demonstrated 94 percent sensitivity and 99 percent specificity, with overall accuracy of 98 percent in a cohort of 150 female participants.
The results, which have not yet been published, are in line with a study published last year in the Journal of Clinical Microbiology by the same investigators that profiled the development of a point-of-care test for Chlamydia run on Lucira's platform in a cohort in Fiji in the South Pacific.
"The data we have seen so far shows the promise of our platform," said Debkishore Mitra, Lucira's CTO and cofounder. According to Mitra, the pilot will continue and a paper describing the work will eventually be submitted for publication. The next steps for Emeryville, California-based Lucira are to take the assay into product development and to seek regulatory clearance for it.
Clarification on the timelines will come after the company assesses "a few variables," he said, "but we are moving this into product development." He noted that the development of the new test signals Lucira Health's move into the STI testing market. Previously the company had developed and launched at-home tests for respiratory viruses, including SARS-CoV-2 and a newer panel for SARS-CoV-2 and influenza. There will be more tests in both categories, too. "We are definitely planning on extending our pipeline," said Mitra.
Mitra cofounded Lucira Health in 2012. Initially called Diassess, it sought to commercialize tests for use on an untethered microfluidic system first developed by scientists at the University of California, Berkeley. Both flu and STI testing have been areas of interest for Lucira Health for years, and the company has racked up numerous grants to support its menu development and has expanded its headcount to about 200 staffers. But it was the company's rapid test for SARS-CoV-2, which relies on a loop-mediated isothermal amplification method licensed from Japan's Eiken Chemical, that allowed Lucira, which went public last year, to raise its profile.
The company gained US Food and Drug Administration Emergency Use Authorization for its COVID-19 test — which is run on a battery-operated device on a shallow nasal swab, and has a turnaround time of about half an hour — in 2020, and has subsequently launched a separate test for COVID-19 and flu, gaining a CE-IVD mark for its assay in May and a Health Canada authorization in August. The company has also submitted the new COVID-19 & Flu Test to the US FDA and is awaiting its feedback.
"COVID-19 helped us in terms of getting the product into the right use case," said Mitra. "It definitely helped us get that use case in front of the FDA and helped to make that jump," he said.
While COVID-19 helped companies like Lucira Health to enter the market and to make at-home molecular diagnostic testing somewhat mainstream, it also produced a slew of firms jockeying to capture the lucrative market for rapid testing, some of whom were perhaps less than reputable. According to Mitra, Lucira Health is well aware of some of the skepticism that at-home testing firms face in gaining market traction but said the "post-pandemic reality" will favor firms that can get their tests cleared by regulators, and weed out less scrupulous players.
COVID-19 testing was done at first to get documentation that an individual was negative so that they could travel, Mitra said, which resulted in the use of inaccurate tests. With restrictions largely removed, the focus will shift toward accuracy, as people seek to determine what illness they have and the appropriate treatments. "I see that environment favoring highly accurate testing that will provide confidence to patients and providers," Mitra remarked. "I think public trust in at-home testing has been colored a bit, but with FDA clearance, you will see that improve."
In an interesting turn, a surge in chlamydia and gonorrhea infections has accompanied the COVID-19 pandemic, making an at-home testing platform for STIs like the one Lucira Health is developing similarly attractive. As a market opportunity, STI testing has the characteristics that can leverage the value of Lucira Health's platform, Mitra noted, "especially its ability to be run at a distributed scale and privately," given the stigma of getting positive STI results.
He noted that a lot of current STI testing is done in centralized facilities, on instruments that are unavailable to lower socioeconomic sector clinics where the prevalence of these diseases is higher. According to Mitra, there is a need for instrument-free molecular tests that can be used in the home or the clinic "in a highly distributed setting" to mitigate the rise in STIs in the US and elsewhere.
He said that other tests for STIs and respiratory viruses are in the company's pipeline. He said that Streptococcus testing was an indication of interest. He also stressed that the company will continue to develop its platform technology.
"I think one of the key foundational principles we have as a company is that we are not trying to create a one-solution-fits-all company," noted Mitra. "We are not trying to create a box that can do everything," he said. "Pipeline expansion goes hand in hand with platform innovation."
That means the company could again license either content or technology for future tests. Lucira Health is also working on a digital health platform to accompany the use of its at-home testing assays. The company previously partnered with Toronto-based Converge Technology Solutions to develop a way to verify at-home SARS-CoV-2 test results and create a document, called a Luci Pass, that could be sent to a GP or employer as proof of a test outcome.
Lucira Health is now developing a digital health platform called Lucira Connect that will enable users with a positive result from one of its tests to access treatment, such as drug prescriptions. Such a framework and ecosystem, he said, would allow an individual to get tested and treatment, if needed, quickly. The company's plan is to introduce the new Lucira Connect platform when it obtains its EUA for the COVID-19 & Flu Test, meaning its launch could be imminent.
"As the flu system hits, this system will become a critical part of any patient's journey," he said.