Medical devices & diagnostics · Allergy testing
Kenota
A Kitchener, Ontario company that spent a decade trying to make allergy testing faster than a trip to the allergist. It won FDA clearance and a CLIA waiver for a fingerstick blood test in 2024, after reporting an $11 million Series A. Y Combinator now lists the company as inactive.
Two kids with swollen backs
Moufeed Kaddoura and Eric Blondeel were University of Waterloo graduates looking up allergy tests online when they landed on the idea. "We saw pictures of kids and they backs swollen up because they were undergoing the current test," Kaddoura said. "We knew as scientists and engineers that we can develop something that was a lot better."
The traditional skin prick test drips allergen extracts onto the forearm, then scratches or pricks the skin to see what reacts. It is unpleasant and in Canada it usually means a referral to an allergist, a wait that can run months.
Kaddoura and Blondeel's first answer was a patch worn on the forearm for about fifteen minutes, meant to pull interstitial skin fluid and read out the IgE level that signals an allergic reaction. "Basically what we're doing is we're picking up the immunological information of the skin and giving you a simple read out of this information," Kaddoura said. ExVivo Labs planned an over the counter peanut patch for children.
From a patch to a blood test
ExVivo Labs entered Y Combinator's Summer 2016 batch and closed a seed round that year from Y Combinator, Tencent Holdings, Pegasus Tech Ventures, OS Fund, Fifty Years and 1517 Fund, per a Golden wiki entry captured in 2018. The company was incorporated in Delaware in 2016, per its own SEC filing.
By the time the company reappears in outside reporting, in 2020, the forearm patch is gone and the name has changed. Kenota Health's product is now a small instrument that reads total IgE from a few drops of fingerstick blood in under thirty minutes, run in an allergist's office. The rename happened sometime between the August 2018 SEC filing, still under ExVivo Labs Inc., and a December 2020 funding writeup that already calls it Kenota Health. No press release marking the rename was found.
The leadership changed too. The 2018 SEC filing names only Kaddoura and Blondeel as executive officers and directors. By 2023 and 2024, Kenota's own press releases credit a different executive, Chris Harder, as chief technology officer. Blondeel's own Y Combinator biography now lists him as co-founder of a separate company, Samos Insurance, from 2022, describing his Kenota role in the past tense.
Five years to a clearance
Kenota told the FDA about its plans in August 2019, per the company's own account. It spent the next several years on bench testing and design work, finishing internal verification studies in 2022 and CLIA waiver studies in April 2023. A method comparison study that spring, at three US allergy clinics with more than 360 patients, compared fingerstick and venous blood results against what the company called an industry standard laboratory assay.
The formal FDA submission went in around mid 2023. The clearance came May 31, 2024: 510(k) K231151, for the Kenota 1 Total IgE test on the Kenota 1 instrument, alongside a CLIA waiver that lets the test run in a doctor's office rather than a certified lab. "This is a major step towards enabling US Allergists and Immunologists to test patients more effectively in their offices," the company said in its release. CTO Chris Harder called it "the culmination of 5 years of development and innovation."
The device measures total IgE in capillary blood by fluorescence lateral flow, reporting results in seven semi-quantitative bands, and is indicated for patients aged 6 to 80 in allergist and immunologist offices. Its predicate device is Phadia's ImmunoCAP Total IgE test, cleared in 2016.
What happened next
As late as May 2025, an archived capture of kenota.com still listed the CLIA waiver and 510(k) clearance as its most recent milestones, describing a 33,000 square foot Waterloo Region manufacturing facility and $11 million in Series A funding. By September 2026 the domain no longer belongs to the company: kenota.com now resolves to an unrelated Vietnamese language gambling review site. Y Combinator's own listing, still titled "Kenota (formerly ExVivo Labs)," marks its status Inactive. Kaddoura's Y Combinator bio now describes him as CEO of a different company, Ranata Therapeutics, and other public profiles list him as a venture partner at 1517 Fund, one of Kenota's own early investors.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA 510(k) K231151 | Cleared May 31, 2024 as a semi-quantitative total IgE test on the Kenota 1 instrument, Class 2, product code DGC, submitted as a Dual Track filing covering both the 510(k) and a CLIA waiver. Predicate: Phadia ImmunoCAP Total IgE, K161899. | Public record |
| Clinical evidence behind the clearance | No clinical diagnostic sensitivity or specificity study was performed. Analytical performance was established with bench testing, precision, linearity and stability studies, plus reference intervals drawn from 117 healthy donors, 95 adults and 22 children. | Public record |
| CLIA method comparison study | Company-described 360-patient study at three US allergy clinics in early 2023, comparing fingerstick and venous blood samples against a laboratory assay. No peer reviewed publication of the results was found. | Company-stated |
| Peer-reviewed publications | No PubMed results found for Kenota, ExVivo Labs, Kaddoura or Blondeel in connection with the allergy test as of September 2026. | Not found |
| Health Canada device licence | No public Health Canada medical device licence for the Kenota 1 system was located in the searches run for this profile. | Not found |
| Total funding raised | Company reported $11 million USD ($14 million CAD) raised through a Series A that closed August 31, 2020, including a $2 million USD seed in 2016. The one SEC Form D on file for the company, filed under ExVivo Labs Inc. in August 2018, two years earlier, shows $5,296,435 sold of a $12,104,996 offering. No later Form D reconciles the two figures. | Differs from filing |
| Operating status | Y Combinator lists the company as Inactive as of September 2026. A University of Waterloo Velocity incubator portfolio page, undated, still lists it as Active. | Conflicting status |
Read plainly: Kenota reached a real regulatory milestone, an FDA clearance and CLIA waiver for a device that measures total IgE from a fingerstick, something few competitors offer at the point of care. What is missing is any published clinical accuracy study, any Health Canada authorization, and any explanation for why the company that announced this achievement in mid 2024 shows every sign, a year later, of having gone dark.
What to watch
- Whether Kenota, Inc. files the specific IgE allergen panel submissions it told the FDA it was developing in 2024.
- Whether kenota.com is ever restored, or whether the company issues any statement about winding down.
- A Health Canada medical device licence for the Kenota 1 system, which has not been found.
- An amended Form D that would reconcile the $5.3 million sold on record with the $9 to 11 million the company has reported raising.
In their words
“We saw pictures of kids and they backs swollen up because they were undergoing the current test.”
Moufeed Kaddoura, co-founder and CEO, CBC News, April 2016 · Independent
“We knew as scientists and engineers that we can develop something that was a lot better.”
Moufeed Kaddoura, CBC News, April 2016 · Independent
“Basically what we're doing is we're picking up the immunological information of the skin and giving you a simple read out of this information.”
Moufeed Kaddoura, CBC News, April 2016 · Independent
“we're extremely encouraged by the milestones we've achieved that move us closer to our goal of improving the standard of care for allergy patients.”
Moufeed Kaddoura, company release, July 2023 · Company release
“both the quality of the results of our CLIA studies and the ease-of-use feedback received were excellent validation of the product we've designed.”
Chris Harder, CTO, company release, July 2023 · Company release
“Kenota has performed rigorous testing with our novel technology and demonstrated that when you truly listen to your customers, great things happen. I am so proud of the team and thankful to our physician advisors for guiding us to this monumental achievement.”
Chris Harder, CTO, company release, May 2024 · Company release
“We are ecstatic to achieve this landmark, which is the culmination of 5 years of development and innovation, catalyzed by some of the most brilliant minds coming together to solve the world's most pressing health issues.”
Moufeed Kaddoura, Founder and CEO, company release, May 2024 · Company release
“Kenota Health is keen on forging collaborations with other industry participants to establish its technology as the go-to solution for in-office testing.”
Moufeed Kaddoura, company release, May 2024 · Company release
Related companies
Sources
- Public recordFDA 510(k) summary, K231151, Kenota 1 Total IgE
- Public recordSEC Form D, ExVivo Labs Inc., CIK 0001750062
- Public recordSEC EDGAR company search for ExVivo Labs Inc.
- IndependentAllergy patch could signal allergies instead of traditional needle test
- IndependentToday in Funding: Potloc, Aifred Health, Kenota Health, Indiegraf
- IndependentDespite small decline in deals, Waterloo Region remained a healthy startup ecosystem in 2020
- IndependentExVivo Labs company entry
- IndependentMoufeed Kaddoura, Forbes 30 Under 30 Healthcare
- IndependentWhat Does Kenota (formerly ExVivo Labs) Do?
- IndependentKenota 1 Total IgE; Kenota 1 (instrument), 510(k) device record
- CompanyKenota (formerly ExVivo Labs) company page
- CompanyKenota Health Announces FDA Submission for Allergy Testing System
- CompanyKenota Health System Receives FDA Clearance and CLIA Waiver Marketing Approval for IgE Testing
- CompanyKenota Health homepage, archived capture
- CompanyKenota Health company page
- CompanyKenota Health portfolio entry
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
