Medical devices & diagnostics · Infectious disease testing
Lucira Health
The first fully at home COVID test, then the first at home flu test. Lucira filed for Chapter 11 two days before the authorization it had bet the company on arrived.
Two days
On February 22, 2023 Lucira Health filed a voluntary chapter 11 petition in Delaware, case 23-10242. The 8-K it filed that day gave the position in one clause: cash on hand stood at “approximately $4.5 million as of the filing date.”
Two days later the FDA authorized the Lucira COVID-19 and Flu Home Test for over the counter use. It was the first combination COVID and influenza test cleared for home use in the United States, and the first flu test Americans could run at home.
The product had arrived. The company had not survived to sell it.
A test built for the decade before
Lucira began in 2013 as DiAssess, Inc., founded by Debkishore Mitra, John Waldeisen and Ivan Dimov out of Luke Lee's bioengineering lab at the University of California, Berkeley. The target was not respiratory disease. It was chlamydia and gonorrhea, where a fast and private molecular result might get someone treated before they passed the infection on.
That set two constraints the company never dropped. The test had to be molecular, because antigen sensitivity misses low pathogen loads early. And it had to be disposable, because the founders did not think people would keep a reader on a shelf for one day a year. The result was a palm sized unit running on two AA batteries, an RT-LAMP reaction read by an onboard optical sensor, and light emitting diodes instead of a screen.
Federal money paid for much of it: $6,619,659 of NIH awards between fiscal 2012 and fiscal 2022, almost all NIAID grants for chlamydia and gonorrhea, plus a BARDA award for an in home influenza test that grew to $21.5 million by September 2019.
The pivot, and the peak
Five years of flu engineering became five years of COVID engineering. Lucira filed its first emergency use authorization request on October 22, 2020 and had it on November 17. Over the counter authorization followed on April 9, 2021.
Net sales went from $0.3 million in 2020 to $93.1 million in 2021, then $90.5 million in the first quarter of 2022 alone, one quarter worth 97 percent of the prior full year. Net income was $13.1 million, the only profitable quarter in the company's history. It was also the top. Second quarter sales fell to $26.1 million, and by September 30 the accumulated deficit was $264.0 million while cash had dropped from $106.0 million to $39.8 million. That 10-Q carried the sentence that ends companies: management “has concluded that its plans at this stage do not alleviate substantial doubt about the Company’s ability to continue as a going concern.”
A buffer, nine samples, and a season
The rescue plan was the combination test. Lucira submitted for over the counter authorization in May 2022 and had its contract manufacturer Jabil ramp production in the Dominican Republic. Health Canada authorized it on August 11, 2022. The FDA did not.
In September the agency raised the toxicity of guanidine hydrochloride in the test buffer, which a home user could swallow. Lucira read the objection as a request for data and ran toxicology studies; the agency wanted the chemical out. The redesign cost months. On November 22 the FDA authorized the test for point of care use only, little help to a company that had aimed its whole commercial effort at retail shelves. The board had already cut 56 jobs in October and a second round followed, about 150 of 225 people in all. Armanino LLP began marketing the assets on December 13 and received no satisfactory offers.
Whose clock
Lucira blamed the regulator. Its bankruptcy release said the company had expected authorization in August 2022 and that “the FDA’s approval process became protracted, resulting in high expenditures without new revenue from the combined test kit during the 2022-2023 flu season.”
The FDA answered in public, which it rarely does. On March 7, 2023 the director of its device center, Jeff Shuren, said the agency was “providing additional information about the agency’s interactions and decisions” as part of its work against misinformation. The first submission, he said, contained a toxic substance in a test component, and its clinical package held nine positive influenza A samples against a posted template recommending fifty. When Lucira returned at the end of 2022 with 35, the agency leaned on NIH manufacturing quality data and authorized anyway.
Both accounts hold. The company planned on a review it did not get; the record says the first submission was not authorizable as filed. Either way it had built inventory for an autumn launch that never came, taken a $107.2 million charge against a cut forecast per Healthcare Dive, and run out of cash.
The auction
The section 363 auction ran on April 6, 2023 and reopened before the court on April 14. Pfizer won both times. On April 19 the court approved the sale at approximately $36.4 million, most of it cure costs and assumed liabilities rather than cash. It closed April 20.
Common stockholders got nothing. The plan confirmed on September 19, 2023 cancelled all 41,763,433 shares. Pfizer took both authorizations on June 15, 2023 and sold the test as Lucira by Pfizer. On October 10, 2025 it asked the FDA to revoke them, reporting no viable reagents left in the country. The revocations took effect October 22, 2025.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| First at home COVID EUA | Issued Nov 17, 2020. FDA called it the first COVID-19 diagnostic test for self-testing at home that provides rapid results. Over the counter authorization followed Apr 9, 2021. | Public record |
| Combination test EUAs | Point of care Nov 22, 2022 (88 FR 3995); over the counter home use Feb 24, 2023 (88 FR 15051), the first at home flu test ever authorized in the United States. | Public record |
| Traditional clearance | A de novo 510(k) for the COVID-19 test was submitted in 2022. No 510(k), de novo or PMA for Lucira appears in the FDA device databases as of Sep 22, 2026. The tests lived and died under emergency authorization. | Not found |
| Clinical evidence | Three completed studies: NCT04720794 (101), NCT04720235 (304) and NCT06141824 (1,361, started Oct 2022). Fierce Biotech, citing FDA, reported the combination test found about 88 percent of COVID positives, 90 percent of influenza A positives and over 99 percent of negatives. | Record and reporting |
| Why it failed | Company: a protracted FDA authorization cycle. FDA: a toxic substance in a test component, and nine positive influenza A samples against a recommended fifty. | Claim differs from the record |
| End state | Trading suspended Mar 6, 2023. All 41,763,433 shares cancelled in Sep 2023 with no distribution. Both EUAs revoked at Pfizer's request, effective Oct 22, 2025. | Public record |
Read plainly: the technology worked, twice before anyone else, and the evidence satisfied the FDA. What Lucira never proved was that a disposable molecular test could hold a market once the emergency faded. One product, one season, one slipped review.
What to watch
- Whether an at home molecular respiratory test returns to American retail. This one left the market in March 2025 and its authorizations were revoked that October.
- Where the patents go. Pfizer bought the intellectual property, then wound the product down.
- The liquidating trust under Brian Ryniker, where unsecured creditors share pro rata in what it collects.
In their words
“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home.”
Stephen M. Hahn, FDA Commissioner, November 2020 · Public record
“Lucira’s strong fourth quarter is indicative of the inflection point the Company is experiencing in its growth.”
Erik Engelson, President and CEO, March 2022 results release · Company release
“The unpredictability of selling into a pandemic made for a very challenging operating environment though collectively, we managed to grow significantly, reached positive net income, and drove continued innovation in our offering.”
Erik Engelson, Chapter 11 announcement, February 22, 2023 · Company release
“We regret that we had no option but to file for Chapter 11 bankruptcy and that this occurred days before we received regulatory authorization.”
Erik Engelson, authorization announcement, February 27, 2023 · Company release
“the FDA determined the test posed a risk to consumers due to a toxic substance identified in one of the test components, making it unsuitable for at-home use”
CDRH statement attributed to Jeff Shuren, FDA, March 7, 2023 · Public record
“The rise and fall of Lucira highlights that microfluidic diagnostic products need more than a great technical innovation, they also need great timing matched with great planning and execution for inevitable regulatory and business hurdles.”
Greenleaf and colleagues, Lab on a Chip, 2025 · Peer reviewed
Related companies
Sources
- Public recordForm 8-K, chapter 11 petition, case 23-10242
- Public recordForm 8-K, Pfizer asset sale approved and closed
- Public recordForm 8-K, plan of liquidation confirmed
- Public recordForm 10-Q, quarter ended September 30, 2022
- Public recordForm 10-K for fiscal year 2021
- Public recordFDA Authorizes First COVID-19 Test for Self-Testing at Home
- Public recordCDRH Statement on the Lucira COVID-19 and Flu Home Test
- Public recordRevocation of Two Authorizations of Emergency Use
- Public recordNIH RePORTER awards AI114068, AI129031, AI152737, OD016718
- Public recordClinicalTrials.gov NCT04720794, NCT04720235, NCT06141824
- Peer reviewedFrom startup to shutdown: the rise and fall of the first at-home combo test
- IndependentFDA defends delayed EUA for Lucira Health’s combo COVID and flu test
- IndependentLucira Health Files for Chapter 11 Bankruptcy, Signals Intent to Sell Business
- IndependentFDA authorizes first at-home flu-COVID-19 combination test days after bankruptcy
- CompanyLucira Health to Pursue Strategic Sale Through Voluntary Chapter 11 Process
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
