Lucira Heath, maker of the first at-home COVID-19 test to receive FDA Emergency Use Authorization, goes public today. This is a major milestone in the fight to end the pandemic, and for us at Eclipse. We’ve been partners in Lucira’s journey since the year our firm launched in 2015.
When we first met the company’s founders — John Waldeisen, Debkishore Mitra and Ivan Dimov — it had been just two years after Lucira (then named Diassess) began out of John’s two-bedroom apartment with his $5,000 in life savings and one Small Business Innovation Research grant from the National Institutes of Health.
Their vision to give the average consumer an on-the-spot, inexpensive diagnostic test that delivers precise results was compelling. To date, people had to live with the tradeoff of either seeing a doctor to get a precise diagnosis, and the inevitable lag time for results, or rely on at-home tests that were less reliable.
Now, we no longer have to choose. And in the grip of a pandemic that has killed more Americans than World War II, today represents a significant milestone for both the company and public health. The amazing team at Lucira deserves praise as they begin the next phase of the journey.
So much has happened since the company’s founding in 2013. In terms of people, the company has grown from three to over 50. And while the company’s original plan was to develop an easy-to-use, at-home test for the flu, the focus has shifted to a solution for a devasting pandemic.
Yes, COVID-19 presented an enormous challenge for Lucira. But it also presented the opportunity every startup talks about tackling, but few actually achieve: to improve the lives of everyday people right now. Even though the impact of the disease hit the company just as suddenly as it did for the rest of us, Lucira rose to the challenge during that first lockdown last spring and emerged with a product that aims to be a major force against the continued spread of the coronavirus.
That product, Lucira’s COVID-19 All-In-One Test Kit, combines a multitude of features that together form a breakthrough that you can hold in one hand. It begins with the core molecular testing technology that is more precise than the other main categories of infectious-disease diagnostics, which test for antigens. Then, there are the features that make Lucira’s test easier to use, such as the simple colors indicating a positive or negative result — and doing so quickly, within 30 minutes.
Another critical feature is the one that democratizes this anytime, anywhere precision testing for all: the relatively low cost of the test itself. That speaks to all the hard work on the business side — innovating on product design, lining up manufacturers and materials, negotiating good contracts, ensuring efficient supply chains, and so much more.
Beyond the product, equally important are the intangibles that got the team to this point. In the early days of the pandemic, Lucira switched its focus from testing for influenza to detecting the SARS-CoV-2 virus. That meant the entire team had to come in and work long hours, side by side, while the rest of us were at home sheltering in place.
Yes, Lucira’s leadership made it clear that employee safety was the top priority, and yes, adequate personal-protective equipment was provided. But what really allowed the team to forge ahead was the trust they had in the company, and the trust they had in each other.
Another intangible that proved pivotal for Lucira was the ability to forge ahead in the face of extreme uncertainty. You may think that the shift in focus from flu to Covid was relatively easy to execute because the fundamental science of molecular testing remained the same, regardless of the virus. But it was dubbed the “novel” coronavirus for a reason: This was the first time humans encountered it. We had no data on how it behaves, and we were learning on the fly.
Despite that, the team made critical decisions throughout on how to test for a pathogen that no one knew anything about — let alone how to detect it. So, there they were, navigating technical complexities as new information was announced daily — and from different sources at the state, national and global levels.
What saved them from drowning? Leadership’s ability to help the team wade through extremely murky waters and make the best decisions possible for how to proceed on limited information.
Ultimately, what brings Lucira to this point are its leaders: the combination of John and Deb’s world-class bioengineering skills in the lab, and the abilities of company President and CEO Erik Engelson to turn a technical innovation into a product and a business — as well as his expertise in navigating the regulated healthcare industry and aligning the many stakeholders in that space. Their shared entrepreneurial spirit served as the glue.
And yet, this is just the beginning. In addition to vaccines and the personal safety measures we’re all taking today, diagnostic testing remains one of the main pillars of this country’s COVID-19 response going forward. As Lucira states in its IPO filing, the demand for diagnostics is estimated to grow to anywhere from 50 million to 100 million tests per month this year.
The company has now realized that ambitious vision that its founders presented to us back in 2015, to create an a simple and affordable at-home test that delivers reliable, lab-quality results quickly. We’re proud to have been a partner on their journey, as they now work to get the test in everyone’s hands.