Diagnostics software · Rapid test interpretation
Scanbase
An API that turns a phone photo of a rapid diagnostic test into a result, sold to the companies that make and ship the tests. Three years after its Y Combinator batch, the public record holds no FDA authorization in its name and no published accuracy figure.
The faint second line
Fifteen minutes after the swab, a rapid antigen test shows a hard control line and, below it, something. A shadow. A blush of color that might be a line and might be the strip drying unevenly. The person holding it has to decide, alone, in kitchen light, what it means.
Scanbase was built to take that decision away from the eye. Point a phone at the strip, and software returns a result. The company’s claim is specific: its algorithms can “detect low positives, or faint lines, beyond what the human eye is capable of detecting.”
That is a large claim, because reading a diagnostic test is not a neutral act of photography. It is the part of the test that produces the answer. Who is allowed to make that call, and on what evidence, is a regulated question.
Whose authorization is it
Lateral flow tests are cheap and decentralized, and the reading is the soft spot. Abingdon Health, a British lateral flow maker that sells a competing phone reader, put it in its own marketing: “their decentralised nature can present a challenge to ensure correct test operation and result interpretation.”
There are two ways a software company can stand in that gap, and they are not the same business.
The first is to hold the authorization yourself. Healthy.io does this. Its Minuteful Kidney test, a urine strip photographed against a color board, cleared the FDA in 2022 for home use, after clearances in 2018 and 2019 for professional versions.
The second is to supply the reading software to the company that holds the authorization. That is what Scanwell Health did. In August 2021 the FDA issued an Emergency Use Authorization for the BD Veritor At-Home COVID-19 Test, which BD called the first at-home COVID-19 rapid antigen test to use computer vision technology in a smartphone to interpret results. The app was Scanwell’s. The authorization was BD’s, and BD said so in the same release: the test “has not been FDA cleared or approved; but has been authorized by FDA under EUA.”
Scanbase sells into the second position. It is a supplier to diagnostics companies, not a test sponsor. The regulatory weight sits with the customer, and the reader has to survive the customer’s submission. Abingdon described what that costs: “it is important to incorporate the smartphone reader into the validation and verification process, as well as external evaluations and clinical trials.”
A founder who watched it happen
Jeffrey Lange had a front row seat for the Scanwell model. According to Scanbase’s August 2023 announcement, he was Head of Design at Scanwell Health and then Director of Product Innovation at Becton Dickinson, the company whose test carried the EUA that Scanwell’s app read. BD described Scanwell as “the first and only to receive FDA 510(k) clearance for an over-the-counter diagnostic smartphone application.”
His co-founder, Steve Roger, is described in the same announcement as a Lead Software Engineer from LinkedIn. The company was founded in June 2022 and joined Y Combinator’s Winter 2023 batch, with Tom Blomfield listed as its primary partner.
What the record shows after that
April 17, 2023: an investment vehicle named Scanbase Leonis a Series of CGF2021 LLC records its first sale. It raised $321,426 from 110 investors and filed with the SEC on May 2.
August 16, 2023: a press release says the product supports more than 40 at-home lateral flow and colorimetric tests, works with all ADx and Whatman style dried blood spot cards, and has started producing software for hardware analyzers in laboratories and hospitals.
Then the trail cools. Searches through September 2026 turned up no further funding, partnership, regulatory filing or trade coverage after August 2023.
The website tells its own story about that stretch. An Internet Archive capture from January 5, 2024 sells a product with a timeline attached: “Implement our Computer Vision algorithm to interpret lateral flow assays in as little as 4-6 weeks.” The site in 2026 sells something else. It now says Scanbase “delivers consulting, implementation, and support services to optimize diagnostic operations,” and the solutions page lists algorithm design, system integration and data analytics. A product company that starts describing itself as a services company has usually learned something about how long enterprise diagnostics sales take.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA authorization | No 510(k), PMA or Emergency Use Authorization found with Scanbase as applicant, in openFDA searches run Sep 24, 2026. No authorized product was found that names Scanbase as its reader. | Public record |
| FDA registration | No establishment registration or device listing under the name Scanbase. | Not found |
| Studies and papers | No registered trials, no PubMed hits, no NIH or NSF awards as of Sep 24, 2026. | Not found |
| Accuracy | The company says its algorithms detect faint lines beyond what the eye can see. No sensitivity, specificity, sample size or comparator has been published. Abingdon Health, by contrast, publishes 98+% sensitivity and specificity for its own reader on a COVID-19 antibody test. | Company-stated |
| Test coverage | More than 40 at-home lateral flow and colorimetric tests, plus all ADx and Whatman style dried blood spot cards, as of August 2023. | Company-stated |
| Named customers | A July 2023 trade article names QuidelOrtho and a women’s health company called Aster. Neither confirmed it in any source found, and Scanbase names no customer on its site. | Unconfirmed |
| Capital | One Form D, belonging to an investment vehicle rather than to Scanbase: $321,426 sold in full to 110 investors, first sale Apr 17, 2023. | Public record |
| Revenue | GetLatka lists $3M for 2024 and labels it an estimate, while listing funding for the same company as $0. | Third party estimate |
| Compliance posture | The SOTA2 vendor listing records: “No compliance claims have been published for this company.” | Third party listing |
| Home city | The YC listing says Los Angeles, CA. The company’s own YC text and the 2023 release dateline say San Francisco. | Sources disagree |
Read plainly: Scanbase is an operating software vendor with a real product claim and almost no public evidence behind it. The distinction that matters most is one it has never had to answer in public. It does not hold an FDA authorization, and it does not need one to sell software to a diagnostics manufacturer, because the manufacturer carries the submission. But that also means no regulator has published an assessment of how well the reading works, and neither has Scanbase.
What to watch
- An FDA submission from any test sponsor that names Scanbase as the reader. That, not a company release, is where accuracy data would first become public.
- Any published validation: sensitivity, specificity, the test panels and the phones tested.
- A customer willing to be named. QuidelOrtho and Aster appear only in a third party article from 2023.
- A Form D or a funding announcement from Scanbase itself. There has been neither since the 2023 vehicle.
In their words
“Our mission is to provide swift and easily accessible healthcare to the global community by building bleeding-edge computer vision and diagnostic software infrastructure.”
Jeffrey Lange, CEO, Scanbase, August 2023 release · Company release
“We believe that everyone deserves access to the best healthcare technology has to offer.”
Scanbase company page, Y Combinator · Company
“Implement our Computer Vision algorithm to interpret lateral flow assays in as little as 4-6 weeks.”
Scanbase home page, Internet Archive capture, January 2024 · Company
“has not been FDA cleared or approved; but has been authorized by FDA under EUA.”
BD, on the BD Veritor At-Home COVID-19 Test read by Scanwell’s app, 2021 · Regulatory statement
“The company is the first and only to receive FDA 510(k) clearance for an over-the-counter diagnostic smartphone application.”
BD, describing Scanwell Health, where Scanbase’s CEO was Head of Design, 2021 · Partner release
“We have the experience, results and regulatory assurances to fundamentally change how Americans monitor chronic conditions using their smartphone camera.”
Yonatan Adiri, founder and CEO, Healthy.io, quoted by Fierce Biotech, 2022 · Independent
“it is important to incorporate the smartphone reader into the validation and verification process, as well as external evaluations and clinical trials.”
Charis Child, Abingdon Health, 2023 · Independent
Related companies
Sources
- Public recordForm D, Scanbase Leonis a Series of CGF2021 LLC, CIK 0001975962
- Public recordFDA 510(k), PMA, registration and listing searches for Scanbase
- Public recordTrial registry, NIH RePORTER, NSF and PubMed searches for Scanbase
- CompanyScanbase Revolutionizes At-Home Healthcare with AI-Powered Diagnostic Solutions
- IndependentScanbase Launches Diagnostic Solutions for At-Home Health Care
- CompanyScanbase company page and Launch YC post
- CompanyScanbase website: home, about, team and solutions pages
- CompanyScanbase home page capture
- IndependentScanbase and the Future of Diagnostic Test Analysis
- IndependentScanbase Revenue 2024: $3M Est. ARR
- IndependentScanbase, Inc. company profile
- PartnerBD Receives Emergency Use Authorization for First At-Home COVID-19 Test to Use Smartphone to Interpret, Deliver Results
- IndependentBD Gets FDA Emergency Authorization for At-Home Smartphone-Read COVID-19 Antigen Test
- IndependentFDA clears Healthy.io’s smartphone-based AI test for early-stage kidney disease
- IndependentHealthy.io receives FDA clearance for smartphone-based home kidney test
- IndependentSmartphones: the Lateral Flow Readers in Your Pockets
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
