Diagnostics & health operations · Blood cell counting
Athelas
A fingerstick white blood cell counter that began as a science fair project and has cleared the FDA three times. Since October 2023 it has been a product line inside Commure, the health operations company its co-founder runs.
A table in a hospital hallway
In 2016 two college dropouts set up a folding table in a hospital corridor in Juarez, Mexico, and offered free blood tests for three days. On one side sat their prototype and a box of lancets. On the other sat a nurse drawing venous blood, so every reading could be checked against a lab.
Deepika Bodapati worked the table. Tanay Tandon watched the images come up on a laptop next door. For days the counts landed where counts land, between 6,000 and 8,000 white blood cells. Then one patient, in for a routine appointment, pricked a finger on a whim, and the number came back above 40,000. The cells were immature, which meant they were being produced in bulk.
The device had no clearance to diagnose anything, so the founders could not tell the patient. They told the hospital staff instead. It took three more weeks to confirm what the two of them had seen in minutes: leukemia.
The monitoring tax
The problem Athelas ended up solving is logistical, not diagnostic.
Clozapine is the most effective antipsychotic for treatment-resistant schizophrenia, and it can suppress neutrophils to the point of danger. A monitoring rule came attached: a blood draw weekly for six months, every two weeks for the next six, then monthly for as long as the patient takes the drug, which for most people is the rest of their life. Every draw is a trip, an appointment, a phlebotomist and a courier. Chemotherapy patients pay the same tax: a low count delays a cycle, and the count is known only after the sample has gone away and come back.
Deanna Kelly, who directs the Treatment Research Program at the Maryland Psychiatric Research Center, had spent two decades on clozapine and was hunting for a point-of-care answer. She found Athelas through its support inbox, and kept writing in.
Two competitors from the science fair circuit
Tandon and Bodapati met as teenagers on the science fair circuit. Tandon began the work that became Athelas in 2014, at 17, on a smartphone attachment meant to spot malaria. That version did not work. The idea of a cheap camera pointed at blood did. Bodapati had interned in the Stanford molecular imaging lab of her uncle Sanjiv Gambhir, who spent his career on early cancer detection.
Tandon left Stanford and Bodapati left USC. Their first test user was Michael Morris, a Stanford basketball player and cancer patient who turned up at their Mountain View office, a barely converted liquor store, and asked to be the guinea pig. Watching his own counts, Morris saw his therapy stop working. He died in 2017.
How a blood analyzer became a billing company
The first clearance came in November 2018, for Athelas One. A second, for the home version, came in March 2022. By then the company had become something else.
During the pandemic Bodapati asked a psychiatrist customer what his non-clozapine patients needed, and the answer was weight, glucose and blood pressure monitoring nobody was doing. Athelas shipped connected cuffs, scales and glucometers, then a pill tracker, then an app. Average deal size went from 10 patients to 600. When the company tried to bill for it, billing turned out to be the harder problem, and revenue cycle management became the business.
In January 2022 Athelas raised $132 million across two rounds at a $1.5 billion valuation, General Catalyst leading one and Tribe Capital the other. In October 2023 it combined with Commure, hatched by General Catalyst in 2017. The merged entity kept the Commure name and a reported $6 billion valuation, with Tandon as CEO and Bodapati as COO. Commure then bought Augmedix for about $139 million in 2024 and Memora Health that December, took $200 million of non-dilutive growth financing in June 2025, and raised $70 million at a $7 billion post-money valuation in May 2026.
What the name covers now
Three things are called Athelas. Athelas Inc. remains the FDA applicant of record on all three clearances. Athelas is also Commure’s brand for revenue cycle, ambient AI and diagnostics sold to clinics. Commure is the company: the parent, the balance sheet, the thing investors buy.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA 510(k) K181288 | Athelas One cleared Nov 5, 2018. Class II automated differential cell counter, product code GKZ, predicate Sysmex XE-5000. Method comparison at three US sites, 312 samples: correlation 0.99 for white blood cell count, 0.96 for neutrophil percent. Flagging of abnormal samples: 90.91% sensitive, 96.71% specific. | Public record |
| FDA 510(k) K200828 | Athelas Home cleared Mar 22, 2022 for patients and caregivers at home. Identical hardware and core software to Athelas One, plus remote lockout, with results routed to the clinician rather than the patient. | Public record |
| FDA 510(k) K243348 | Cleared Feb 6, 2026, adding multiple-patient point-of-care use. At-home comparison against Athelas One on 165 samples: correlation 0.97 for white blood cells, 0.92 for neutrophil percent. Over 94% ran with no error. | Public record |
| Cleared measurands | Still only white blood cell count and neutrophil percent, adults 21 and older, prescription only, on all three clearances. | Public record |
| The CLIA waiver claim | The February 2026 release and the product page describe “an FDA-cleared, CLIA-waived hematology analyzer” and trade outlets repeated it. FDA lists all three Athelas submissions as Traditional 510(k)s, no CLIA Waiver by Application appears under the company name, and the K243348 letter and summary never mention CLIA. | Claim differs from the record |
| Peer-reviewed evidence | Kelly et al., Annals of Clinical Psychiatry, 2021: feasibility and satisfaction using Athelas One for clozapine monitoring. Foo et al., Community Mental Health Journal, 2026: uptake at two clinics of 22% (10 of 45) and 60% (120 of 199) of clozapine patients, with provider burden and no reimbursement named as barriers. | Independent |
| The standard of care claim | The 2022 company announcement states: “Today, the Athelas Home platform is standard of care for Clozapine treatment.” The 2026 study is the closest independent measure, and it shows uptake between a fifth and three fifths. | Claim differs from the record |
| Wider blood panel | The same announcement said the platform could also measure platelets, hemoglobin, a full differential, malaria and blast cells, “all currently in clinical trials or FDA review.” No clearance for any appears in the FDA database as of Sep 22, 2026. | Not found |
| Early regulatory claim | TechCrunch reported in August 2017 that “The device is also FDA-approved under a class 1 registration.” The first 510(k) came 15 months later, and the device is Class II. | Claim differs from the record |
| Scale | Commure reports over 500 healthcare organizations, 3,000 or more sites of care, and 130 or more large health systems including HCA and Tenet. The product page reports 40,000 patients and 1,000,000 tests. None is audited. | Company-stated |
Read plainly: the device is well documented. Three clearances, a named predicate, correlation coefficients in the FDA file, one independent paper on feasibility and one on uptake. Outside the record sits the marketing layer. The CLIA claim, the standard of care claim and the 2022 list of forthcoming measurands all run ahead of the FDA database. That gap matters here, because diagnostics is now the smallest part of a company whose valuation rests on billing software.
What to watch
- Whether a CLIA Waiver by Application ever appears in the FDA record for Athelas Home.
- A fourth 510(k) covering platelets, hemoglobin or a full differential, promised in 2022 and not yet filed.
- Reimbursement for point-of-care fingerstick testing, which the 2026 study names as a barrier.
- Whether diagnostics survives inside Commure. Tandon has said the company will likely be IPO-ready by 2027.
- The next Form D. Commure has filed none, and the only Athelas filings belong to outside vehicles.
In their words
“It’s this concept of making tools so cheap, so usable, that people can do it all the time. Only then can you actually get preventive care.”
Deepika Bodapati, co-founder, Sequoia, 2022 · Investor profile
“There would be no company if there was no trial.”
Deepika Bodapati on the first trial, Sequoia, 2022 · Investor profile
“Once I heard about Athelas, I was like, I don’t know if this is too good to be true.”
Deanna Kelly, Maryland Psychiatric Research Center, 2022 · Independent
“One of our goals is to become a companion diagnostic for a lot of these interesting drugs.”
Tanay Tandon to TechCrunch, August 2017 · Independent
“It’s clear that there’s going to be definitive, enduring businesses built during this time that transform the economy.”
Tanay Tandon to Fierce Healthcare, October 2023 · Independent
“We have spent years working through the FDA regulatory process to prove that AI can deliver lab-grade results in any environment.”
Tanay Tandon, February 2026 clearance release · Company release
“This technology has enabled clozapine for patients who had no other options.”
Nicholas Eisemann-Astone, Cactus Garden Mental Health Services, 2026 · Company release
Related companies
Sources
- Public recordFDA 510(k) decision memorandum, K181288
- Public recordFDA 510(k) decision summary, K200828
- Public recordFDA 510(k) letter and summary, K243348
- Public recordForm D, Athelas Inc., CIK 0001857376
- Public recordForm D, Athelas Investors LLC and Athelas Investors II LLC
- IndependentFeasibility and patient-reported satisfaction using a novel point-of-care fingerstick method
- IndependentImplementing Point-of-Care Fingerstick Testing for Clozapine Safety Monitoring
- IndependentAthelas hits unicorn status with $132M raised
- IndependentAthelas is an at-home blood testing device made for cancer patients
- IndependentCommure, Athelas unveil merger plans
- IndependentCommure raises $70M, valuation to $7B
- InterviewDeepika Bodapati and Tanay Tandon of Athelas: The Listeners
- CompanyAthelas Home Expands AI Diagnostics to the Point of Care
- CompanyAnnouncing the landmark FDA Clearance of the Athelas Home
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
