Medical devices & diagnostics · Rapid infectious disease testing
Clip Health
A glow-in-the-dark nanoparticle test read by an ordinary smartphone camera. It won a federal emergency authorization in December 2020, shipped more than a million units, and in May 2023 asked the FDA to revoke it.
The star on the ceiling
One night in 2012, Richard Willson was putting his young daughter to bed and found himself staring at a glow-in-the-dark star stuck to her ceiling. Willson is a professor of chemical and biomolecular engineering at the University of Houston, and he had long admired one particular piece of consumer technology.
“The home pregnancy test format is one of the most remarkable technical developments that anybody ever made,” he told his college’s news office years later.
A pregnancy test is a lateral flow strip: a paper wick, a line of antibodies, colored particles that pile up where the target binds. It costs cents and anyone can read it. Its weakness is sensitivity, because a gold particle is only so visible to the eye. The star was a phosphor. Charge it with light, switch the light off, and it keeps glowing. The next day Willson took it down and handed it to Andrew Paterson, a doctoral student in his lab working on light-based diagnostics.
Why a glowing particle matters
Swap the gold for a persistent phosphor and the physics changes. A phone flash charges the strip, the flash goes off, and the camera opens its shutter a moment later, when the only light in the scene is coming from the particles. No optical filter, no laser, no dedicated reader.
“The main reason all of this is cheap is because of an imaging technique called time-gating,” co-founder Bala Raja told the trade publication 360Dx in December 2019, a year before anyone had heard of the product that would make the company briefly famous. The team put the payoff at roughly a hundredfold lower limit of detection than a conventional colored strip, a company figure that no independent laboratory has published.
Two chemical engineers
Raja and Paterson both took chemical engineering doctorates out of Willson’s lab, and both spent their last graduate years pitching the idea in a University of Houston class built for the purpose.
The memorandum that offered the company for sale in 2023 dates the founding to 2014 in Houston; a 2021 account in a Houston trade publication says 2015. Both agree on what followed: Y Combinator’s Summer 2016 batch, a move to Silicon Valley, and seed financing that closed in November 2016 from Khosla Ventures and Y Combinator, with Lynette Capital named in later reporting.
From 2017 to early 2020 this was a sexually transmitted infection diagnostics shop living on small business awards from the National Institute of Allergy and Infectious Diseases: chlamydia first, then gonorrhea, with a herpes simplex virus type 2 self-test written up in PLoS One in 2019. The platform paper had run in Lab on a Chip in 2017. Five NIAID awards totaling $2,670,173 sit in NIH RePORTER.
The pandemic, and the money
On April 16, 2020, Sanofi announced an agreement to evaluate a collaboration with Luminostics on a consumer COVID-19 self-test, aiming to have it ready before the end of that year. No authorized product ever came out of it.
Federal money did. On September 30, 2020 the NIH signed contract 75N92020C00029 with Luminostics under the Rapid Acceleration of Diagnostics program. NIH published a budget of $26,120,000. By the time the contract closed in September 2023, USAspending records $39,067,500 obligated and paid. On December 7, 2020 the FDA issued EUA202907 for the Clip COVID Rapid Antigen Test, limited to laboratories certified under CLIA, including point-of-care sites operating under a Certificate of Waiver.
The Air Force added a $2,000,000 contract in August 2021 for test kit production expansion. In September 2021 the company rebranded as Clip Health and said it would file two more emergency use applications within weeks: an over-the-counter self-test, and a combined COVID-19 and influenza A/B test on a new palm-sized analyzer called Clip Core.
How it ended
Neither application was ever authorized. The sale memorandum put it flatly: “FDA de-prioritization of this OTC EUA resulted in an attempted pivot in 2023 to product focus on at-home heart failure management; fundraising attempts to support further development failed.”
On May 2, 2023 Luminostics wrote to the FDA asking the agency to withdraw the authorization. Three days later the agency did. “FDA understands that as of the date of this letter there are no viable Clip COVID Rapid Antigen Test reagents remaining in distribution in the United States,” the revocation letter reads.
That sequence is worth being precise about. COVID-19 test authorizations did not expire when the pandemic emergency wound down. The authorization letter says an EUA runs until the underlying section 564 declaration is terminated or the authorization is revoked. This one was revoked, at the company’s own request, because there was nothing left to sell. Five days later a restructuring firm was retained to auction the assets.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA EUA202907 | Issued Dec 7, 2020 to Luminostics, Inc. Emergency use limited to CLIA certified laboratories, including point-of-care settings. Revised Sep 23, 2021, reissued in full Mar 4, 2022, revised again Nov 1, 2022. | Public record |
| Authorization is not clearance | The labeling states the product “has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories.” openFDA returns no 510(k) and no premarket approval for either company name. | Public record |
| Revocation | Revoked May 5, 2023 under section 564(g)(2)(C), in response to a company letter received May 2, 2023, and signed by the director of the Center for Devices and Radiological Health. | Public record |
| Clinical data behind the EUA | 166 nasal swabs from symptomatic patients enrolled within five days of symptom onset, 163 evaluable. 31 of 32 RT-PCR positives detected. Positive percent agreement 96.9 percent, 95 percent CI 83.8 to 99.9. Negative percent agreement 100 percent. | Public record |
| The asymptomatic indication | The March 2022 reissue extended the intended use to people without symptoms tested twice over three days. The clinical performance section of that same labeling states: “All patients enrolled in the study were symptomatic.” | Public record |
| The accuracy claim | Releases called Clip COVID “among the most accurate FDA-authorized rapid antigen tests available on the market.” The labeling rests that on 32 PCR-positive specimens, with a confidence interval running down to 83.8 percent. | Claim outruns the data |
| Federal funding | RADx contract 75N92020C00029, $39,067,500 obligated and outlaid. Air Force contract FA821021C0001, $2,000,000. NIAID influenza contract 75N93019C00024. Five NIAID grants, $2,670,173. | Public record |
| Units shipped | The sale memorandum says more than 700,000 units were produced. The founder’s Y Combinator profile says the first product “shipped >1m units but failed to parlay into sustainable growth.” | Company-stated |
Read plainly: the science is real and published, the authorization was real and narrow, and the company that held it is gone. Clip COVID was authorized for professional point-of-care use only. It was never authorized for the home, the market the founders had aimed at since graduate school. Public money paid for the line that made the professional test, and when that test stopped selling there was no consumer product behind it.
What to watch
- Where the patents landed. The sale listed three issued and four pending, with the core claims under exclusive licence from the University of Houston. No completed sale appears on the public record.
- Whether the Clip Core analyzer resurfaces under another owner. It was design-locked and transferred to manufacturing when the company stopped.
- Both founders are now listed as former founders on the Y Combinator page, and neither corporate domain served a web page in September 2026.
In their words
“The home pregnancy test format is one of the most remarkable technical developments that anybody ever made.”
Richard Willson, University of Houston, 2021 · Independent
“I never would have imagined that the glow-in-the-dark star would have kicked off a chain of events that included glow-in-the-dark nanoparticles for diagnostics becoming the main focus of my Ph.D.”
Andrew Paterson, co-founder and CTO, 2021 · Independent
“The simplest way to describe what we have done with our system is to say that we have turbocharged the lateral flow format, while maintaining a low cost and small form factor that will enable it to be used over-the-counter for testing.”
Bala Raja, co-founder and CEO, 360Dx, 2019 · Interview
“The diagnostics industry is saturated with products that cater to big, centralized labs or testing in the doctor’s office.”
Andrew Paterson, 2021 · Independent
“Demand for the Clip COVID is currently far outpacing supply, but we will continue to ramp up production until this virus abates and the market tells us to stop.”
Bala Raja, company announcement, February 2021 · Company release
“Clip Health, as a name, aligns with our products’ central value of delivering speedy, easy-to-obtain access to your health data, thereby trimming inefficiencies in healthcare delivery.”
Bala Raja, rebranding announcement, September 2021 · Company release
“FDA understands that as of the date of this letter there are no viable Clip COVID Rapid Antigen Test reagents remaining in distribution in the United States.”
FDA revocation letter, EUA202907, May 5, 2023 · Public record
Related companies
Sources
- Public recordLetter of Authorization, EUA202907, reissued
- Public recordRevocation of EUA202907
- Public recordClip COVID Rapid Antigen Test instructions for use
- Public recordContracts 75N92020C00029 and FA821021C0001
- Public recordRADx funding list, awardee Luminostics, Inc.
- Public recordNIH RePORTER, seven awards to Luminostics, Inc.
- Public recordA low-cost smartphone-based platform for point-of-care testing with persistent luminescent phosphors
- IndependentCullen Alums, Prof’s Smartphone-Based COVID-19 Test Hits Market
- InterviewLuminostics’ Luminescent Particle Lifts Sensitivity in OTC Test Prototypes
- IndependentUniversity of Houston spinout’s smartphone-based COVID test
- IndependentSanofi and Luminostics to develop a smartphone-based self-testing solution
- CompanyDate Certain M&A of Clip Health, its assets and intellectual property
- CompanyLuminostics announces FDA authorization and production scale-up
- CompanyClip Health company and founder profiles
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
