Case Study: Lucira Health
Key Metrics
30 min
Test-to-result time
1M+
Rapidly scaled production to ~1M units/month
First
FDA-authorized home molecular test for COVID-19
98% +
Accuracy compared to lab-based PCR
Origin Story
Traditional molecular tests required lab infrastructure and trained technicians. At-home rapid antigen tests sacrificed accuracy for convenience.
Create an at-home test combining molecular test accuracy with the simplicity of a pregnancy test—no lab, no equipment, no prescription, just results in 30 minutes.
Our work with molecular diagnostics began as graduate students back in Luke Lee's lab at UC Berkeley, where we pioneered microfluidic technologies for sample prep, isothermal DNA amplification, and electronic readout. Lucira Health spun out of the university in 2013 with the mission of bringing laboratory quality diagnostics into the home and remote healthcare settings, empowering everyday people to make more informed health decisions.
Thanks to a combination of non-dilutive funding and private investment, we build an incredible team and a handheld diagnostic platform technology. By 2019, we had begun clinical trials for an influenza test.
Luke encouraged us to think about global health. At that time, isothermal DNA amplification was still very new, and we were interested in how it could be applied to reduce the cost and complexity of molecular diagnostic devices for resource poor settings.
— Frankie Myers, PhD
The COVID-19 pandemic highlighted the critical need for accurate, accessible diagnostic testing outside traditional laboratory settings, and after seven years of platform development, Lucira was uniquely well positioned to address this need.
Within weeks of the start of the pandemic, we had begun clinical trials, and in November 2020, we became the first company to receive FDA Emergency Use Authorization for a home-use test for COVID-19. Unlike the lateral flow immunoassays that eventually dominated the market, Lucira's test provided analytical sensitivity on par with lab-based PCR and became the preferred test for many market segments that could not compromise on performance. Lucira significantly scaled operations through 2021, culminating in an IPO that funded rapid manufacturing scale-up to >1M devices/month.
Lucira went on to receive FDA authorization for the first over-the-counter combination flu and COVID-19 test in February 2023. Unfortunately, this authorization came just two days after the company declared bankruptcy. The protracted regulatory review for the combo test meant that Lucira was unable to sell its substantial 2022 inventory during that year's flu season. The dramatic rise and fall of Lucira has been the subject of an academic case study.
Lucira became Mosaic's first customer in 2021 and remained a customer through bankruptcy and subsequent acquition by Pfizer. The company's journey taught us invaluable lessons about the realities of scaling innovation.
Mosaic arose directly from the lessons learned at Lucira. We saw firsthand the immense challenges of translating university technologies into viable products.
University research programs offer many things—insights into scientific and technology trends, mentorship to explore new ideas, and a network of lifelong colleagues and friends. But they don't often prepare graduates for the realities of building successful products.
We started Mosaic to help other academic innovators make fewer mistakes, make more efficient use of capital, and have a better shot at building successful products.
Timeline
2015
Company raises seed round, joins Y Combinator and StartX accelerators
2019
Initial FDA 510(k) application for flu test filed and later withdrawn
2021
Successful IPO, scaled to 1M devices/month manufacturing capacity
2025
Pfizer ceases production
2013
Founded as Diassess, Inc. by John Waldeisen, Debkishore Mitra and Ivan Dimov from UC Berkeley with SBIR funding
2017
Awarded $21M development contract from BARDA for a POC influenza test
2020
Company becomes first to receive FDA Emergency Use Authorization for COVID-19 home test
2023
FDA authorization for first OTC flu & COVID test; bankruptcy & acquisition by Pfizer
Technology
Traditional molecular tests require lab infrastructure and trained technicians. Lucira's handheld, battery-powered platform allowed anyone, anywhere, to perform PCR-equivalent testing in 30 minutes.
Novel detection method for isothermal nucleic acid amplification, dramatically simplifying readout instrumentation.
Innovative fluid loading mechanism allowing dead-end chambers to fill without valves.
A single PCB provided assay incubation, detection, signal processing, and result display.
Eight independent reaction chambers with integrated light pipes arranged in a circle ensured thermal uniformity and allowed multiplexed readout from a single photosensor.
Challenge
The product featured a polymerase enzyme and other assay components which needed to be lyophilized for room temperature stability.
Solution
We chose pellet lyophilization for its manufacturing scaling advantages, building an in-house dry room with robotic pick-and-place processes and working closely with lyophilization partners on pellet integrity and drying protocols.
Challenge
Ensuring reliable microfluidic performance in an uncontrolled use setting with inexpensive components.
Solution
Low cost injection molded reaction chamber design, careful attention to user touch points & alignment features, and tight manufacturing QC of critical components. Micro-CT imaging enabled root-cause analysis of particular failure modes in microfluidic assemblies.
Challenge
Achieve tight temperature tolerances across all eight reaction chambers.
Solution
We optimized the PCB heater design through thermal FEA and experimental methods, with board cutouts and tight copper plating thickness control.
Challenge
Ensure repeatable light transmission through the reaction chambers to the photo sensor.
Solution
We designed lensing elements and light pipes to collimate LED light onto a central photosensor, validated with ray tracing simulations.
Challenge
Ensuring ease-of-use for all users in an uncontrolled, unsupervised setting.
Solution
Through 1,000+ observational user studies, we refined every aspect of the design and instructions, measuring tactile forces and evaluating individual word choices.
Challenge
Scaling a product to over 10M units/year during a global pandemic.
Solution
We rapidly qualified high-volume multi-cavity tooling and designed three alternative PCBAs with different firmware and parts to work around supply shortages.
Challenge
Ensuring the product could be efficiently assembled at high volume.
Solution
We engaged automation engineers from the start, designing logical subassemblies for batch processing and ultimately automating the full assembly line.
Product
Simple nasal swab collection—no special training required.
Place swab into the test vial containing reagents.
Insert vial into battery-powered test unit. The device will start automatically.
After 30 minutes, read the visual indicator. Positive and negative results will display clearly for COVID-19, Flu A, and Flu B.
Key Learnings
Mosaic attracts top talent by focusing on complex, high-impact problems. We foster a culture that values internal R&D, spin-outs, and grant writing to encourage breakthrough thinking.
For commercialization, regulatory pathways, and manufacturing, deep expertise is vital. Our wide advisor network brings decades of real-world experience to every project.
Clear regulatory and reimbursement plans are foundational. We collaborate with seasoned experts across medical specialties to guide strategy from day one.
Great tech isn't enough—market readiness and competition matter. We help evaluate timing, differentiation, and go-to-market viability.
We lean into our partnerships with trusted vendors and transparently recommend third parties when they're the best fit.
Simplicity is essential for consumer health. We can help you put your product in front of its intended users early on, providing crucial feedback on usability.
Lucira secured nearly $30M in grant funding. At Mosaic, we've refined our SBIR grant-writing process using expert consultants and AI-assisted pipelines. We serve on review committees for these grants ourselves, and we know what wins.
Mosaic operates lean by leveraging AI and a flexible network of consultants and vendors. We scope prototypes strategically to maximize insights without expanding overhead.
We prioritize early engagement with key vendors and align product design with cutting-edge biomedical manufacturing methods.
Rapid iteration requires tight integration. We built Mosaic to house full prototyping capabilities and leverage on-campus facilities for scale and speed.
"This project taught us that truly innovative design means making complex science feel simple, accessible, and trustworthy."
Mosaic Design Labs – Dr. Frankie Myers, PhD
Let's create products that make complex technology accessible and human-centered.
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