NEW YORK – Lucira Health is aiming to change the way infectious disease is diagnosed in the US by empowering patients to perform accurate testing at home. The company was the first to obtain Emergency Use Authorization for a home-use molecular diagnostic for SARS-CoV-2 and is now scaling up manufacturing and positioning itself for future applications, all while emphasizing a consumer-friendly approach.
Formerly known as Diassess, Lucira was founded on core technology developed at the University of California, Berkeley. Scientists at the firm worked with different isothermal nucleic acid amplification methods for instrument-free molecular assays to detect infectious diseases like chlamydia and other sexually transmitted infections, as well as influenza.
For its SARS-CoV-2 test, the Emeryville, California-based firm settled on loop-mediated amplification, which it licenses from Eiken Chemical of Japan. LAMP is a method of choice for a number of diagnostics developers — such as Detect, GeneMe, and MicrosensDx — including those working on screening tests and paper-based assays.
The Lucira test obtained prescription home-use authorization from the US Food and Drug Administration to much fanfare in November. It is a single-use molecular assay with a disposable battery-operated reader, and it is currently authorized for home-use by prescription. The firm has been working to obtain an OTC clearance as well, and expects to submit an application in the first half of this year.
At 30 minutes, the Lucira assay has a substantially faster turnaround time than most traditional lab-based molecular tests but is slower than lateral flow antigen tests. It also does not require any special training to run, and because it amplifies viral RNA, it has sensitivity advantages over viral antigen tests. Lucira has purportedly designed the test to be affordable, as well. The firm is currently selling it to licensed healthcare providers at $1,200 for 24 single-use test units, or $50 per test, although it has disclosed it anticipates an OTC price of $20 per test.
But these advantages may still not be enough to actually reach consumers, in part because the OTC infectious disease testing market has previously consisted of a single test – the OraSure OraQuick home-use HIV test – and average consumers may not understand the nuances of performing all the steps and interpreting the results of a diagnostic test at home.
Kelly Brezoczky, Lucira's executive VP of commercialization, regulatory, clinical, and business development, said the firm is making a concerted effort to connect with consumers and make its test approachable.
This begins with the workflow, she said, which has been simplified to "swab, stir, detect."
Ease of use is critical, because "it has to be easy if you are going to cross into the consumer, over-the-counter-use channel," she said. This allows people to not only accurately test themselves, but also to feel confident that they can trust the results, which in turn can potentially impact their behavior.
Brezoczky has been with Lucira since November 2019, when she joined the firm to help take flu testing to the OTC market. She is a self-described "classically-trained consumer products person," previously serving as CEO of Butterfly Health, a personal hygiene product company she founded, and as a founder and managing director of a consulting firm. She also spent eight years as a marketing executive at Proctor & Gamble.
Lucira's extra efforts to ensure its test will be easy to use for consumers will potentially differentiate it from home-use molecular competitors, she said.
"We are not bringing a science experiment into the home," Brezoczky said, adding that in the consumer space, usability is as important as product performance.
There are currently 15 COVID-19 antigen tests with EUA on the market, 12 of which are CLIA waived, and three of which are explicitly for home use, while there are two molecular tests for prescription home use.
Brezoczky said other authorized COVID-19 tests targeting consumers have instructions that contain "pages and pages of five-point font." Lucira, meanwhile, worked with more than 1,000 consumers to develop its testing instructions. It then ran its own usability and user comprehension studies for prescription home-use authorization — no small feat in a pandemic.
The firm relied on Zoom for many of its consumer interviews, but for the actual clinical validation studies, it also visited participants outside their homes. "They were just handed one of our kits, with no supervision or training, and most people ran the test on top of a recycling bin, trashcan, or the hood of their car," Brezoczky said. The firm demonstrated that 100 percent of users were able to correctly use the test in this setting.
Lucira hasn't yet had the chance to compare its test to EUA antigen assays due to issues of availabilty, but from the limits of detection she expects in the OTC context, she said the Lucira test will likely be more accurate, and if true, that could engender a "simple language superiority claim" that consumers understand well.
The assay's limit of detection is 1,000 viral copies per milliliter or less, and Brezoczky said the firm recently showed it was on par with lab-based molecular testing: the test showed 94 percent positive agreement and a 98 percent negative agreement with the Hologic Panther Fusion RT-PCR SARS-CoV-2 test.
And although a consumer may not vibe with terms like "isothermal nucleic acid amplification test," descriptions like "lab-quality molecular accuracy" and "PCR-like molecular accuracy" can now be used to differentiate Lucira's MDx from antigen testing, Brezoczky said.
Competition for home-use molecular diagnostics currently includes Cue Health, which obtained OTC clearance for a SARS-CoV-2 test earlier this month, and Visby Medical's emergency-authorized CLIA-waived single-use molecular test.
With respect to Cue's test, Brezoczky said Lucira's is the only single-use molecular test kit, while the Cue test is more of a "lab in a box," with a reader that needs to be cleaned and maintained, as well as cartridges, she said. Separately, however, at least one developer of a competing product has previously suggested that Lucira's battery-powered disposable testing units would contribute to electronic waste.
Nevertheless, Brezoczky said while there will be room in the marketplace for both home-use molecular tests, for negative verification specifically, "a test that is single-use and fully disposable represents a very large market opportunity."
Although Lucira is targeting the OTC market, since obtaining its prescription home-use EUA, the test has been in limited supply and has been primarily available to certain hospital groups in California and to clinicians who order it over the firm's website. Last month, Lucira went public in a $153 million initial public offering (IPO), in part to fund manufacturing at a higher scale.
"We will continue to build our manufacturing through the year, and we are looking forward to having the opportunity to have our test in the over-the-counter space," Brezoczky said, adding that manufacturing is increasing, as the firm has expected, and that it is excited to be in a position to be rolling out its tests more broadly.
When initiating coverage of Lucira earlier this month, analysts at William Blair said that use cases for fully at-home molecular tests for infectious disease are "large and still evolving," further opining that the durability of the OTC market is "underestimated." Executives at Quidel also recently said the future of their company "will include a very significant contribution from an emerging OTC and at-home testing market," while those at OraSure cited a study estimating a need for 300 million COVID-19 tests per day just to resume normal operations of schools and noted that global demand may be even higher and more sustained in the future.
Over-the-counter marketing of infectious disease tests for strep throat and flu made some testing experts gasp before the pandemic. Now, things have changed. Even laypeople seem to know all about rapid antigen tests, and are savvy that PCR is the "gold standard," while countries such as Germany have started selling OTC COVID-19 antigen tests in supermarket chains.
According to Lucira's S-1 initial registration form, filed with the SEC prior to its IPO, the firm estimates a current annual market size of approximately $6 billion for molecular COVID-19 testing.
To date, there have been more than 121 million cases of SARS-CoV-2 diagnosed globally, and 2.7 million deaths, with cases in the US closing in on 30 million and resulting in nearly 540,000 deaths. Meanwhile, COVID-19 diagnostic volume in the US is rapidly growing and, as of November 2020, exceeded 30 million tests per month with estimated monthly demand expected to increase up to 50 million to 100 million tests during 2021, the firm wrote. And yet, "the world continues to struggle with monitoring and containing the outbreak of COVID-19."
While some have speculated that demand for COVID-19 diagnostic testing will decrease over time as mass vaccinations proceed and transmission of the virus is reduced — and companies like Quidel have recently guided for lower-than-anticipated revenues — mass screening of asymptomatic people for COVID-19 appears even more critical than it might be for many other infectious diseases.
This is in part because the SARS-CoV-2 virus is transmissible before a patient first experiences symptoms, and can also be transmitted by people with mild symptoms, or none at all. This wrinkle was hard to anticipate, as previously noted by the former coronavirus testing czar.
Government agencies like the National Institutes of Health's Rapid Acceleration of Diagnostics program (RADx), as well as firms such as Quidel, Becton Dickinson, Abbott, and OraSure Technologies, have surmised that prescription at-home and non-prescription OTC testing will be critical to ending the pandemic. Others, such as Chembio, have hypothesized that infectious diseases will continue to be diagnosed in a clinical setting, albeit perhaps nearer to the patient.
To Brezoczky, the COVID-19 pandemic is a watershed moment, analogous to the way that September 11th irrevocably changed the security precautions required for air travel in the US. "There is an increased realization that COVID is here to stay," she said. "It is going to be an endemic disease that we are managing, just like influenza."
Also, because SARS-CoV-2 is transmissible by asymptomatic people, proof-of-health testing could become a fact of life for years to come, she added.
Lucira has developed and branded a method to certify that a person has tested negative, called a "Lucy Pass," which is part of an optional text-based download available with the test. Consumers could potentially use this pass when they need to spend time in enclosed spaces, such as in the office, on a flight, or visiting family in a nursing home, for example. This negative verification is quite different from standard diagnostic testing, and "is opening up emerging and new channels of testing that really didn't exist previously, or quite frankly that there was a need for," Brezoczky said.
Should SARS-CoV-2 become endemic and circulate along with influenza, people may also need to detect and distinguish the two illnesses. Home-use testing is ideally suited to keep potentially infectious people with mild influenza-like illness, or ILI, safely quarantined.
Specifically, Lucira said in its S-1 that a rising demand for influenza vaccines, coupled with the inability to definitively determine based on symptoms alone whether a person has COVID-19 or influenza or another viral infection, "translates to greater interest in products to diagnose and treat ILI."
Lucira estimates the total potential annual market for OTC flu testing alone could be in excess of $800 million. An estimate from Nielsen of approximately 200 million people per year purchasing treatments for the symptoms of ILI, coupled with an OTC retail price of approximately $20 per test kit, translates to a total addressable market of up to $4 billion, the firm wrote.
Lucira is now working towards the OTC submission later this year – a path that could potentially be accelerated by new FDA guidance for serial testing of asymptomatic people. Lucira also expects to submit a prescription-use combined influenza and COVID-19 test kit to the FDA in 2022, and obtain OTC authorization for a combined kit in 2024, according to the S-1 document.
While COVID-19ndiagnostic testing may decline, negative verification in emerging channels is likely to increase, Brezoczky said. And, "if there is one trend that the pandemic has accelerated, it is the shift into the home," she added.