Oncology diagnostics · Functional precision medicine
Known Medicine
A Salt Lake City company that grew hundreds of micro-tumors from one patient sample and dosed each, to tell an oncologist what would work. It raised $7.2 million, registered a 2,000 patient study, published no validation data, and was absorbed into Pathos AI in 2023.
Three hundred tumors from one
A surgeon takes out at least a cubic centimetre of tumor, or drains more than 100 millilitres of fluid from around a patient’s lung. Under the protocol Known Medicine registered, that tissue had to be moving toward Salt Lake City within 24 hours, in a kit the company mailed out, with a vial of the patient’s blood.
In the lab the tissue was washed and digested to single cells. Cancer cells were sorted from stromal cells, stained with a membrane dye and set into a 3D matrix in a multi-well plate. The cultures rested 48 hours. Then the drugs went in. Seventy two hours later a fluorescence camera read every well.
From one sample the company said it could build more than 300 micro-tumors and test more than 30 treatments, with the readout reaching the oncologist inside seven days, weeks before a sequencing report. That is the whole proposition: run the experiment on the tumor instead of on the patient.
The record this idea had to walk past
The idea is old and the evidence behind it has been unkind for a long time. Testing a patient’s own cancer cells against drugs in a dish has a name in the literature, the chemotherapy sensitivity and resistance assay. In 2004 the American Society of Clinical Oncology reviewed the field and advised against using it outside a trial, citing small samples, few prospective studies and low assay yield.
In 2011 an ASCO working group went back through everything published between December 2003 and May 2010. Of 11,313 articles, five randomised trials survived to data extraction. The conclusion was blunt. “Review of the literature does not identify any CSRAs for which the evidence base is sufficient to support use in oncology practice.” The recommendation followed: “The use of CSRAs to select chemotherapeutic agents for individual patients is not recommended outside of the clinical trial setting.” ASCO said it again in a 2014 breast cancer guideline: “in vitro chemoresistance assays should not be used to select treatment.”
Known Medicine’s answer was that the biology underneath had changed. The old assays grew cancer cells alone on flat plastic. Its M3DUSA model put cancer, stromal and immune cells together in a hydrogel scaffold built for robots, and read the result with machine learning on images rather than a live and dead count. Whether that is enough is an empirical question.
A thesis defence and a shutdown
Andrea Mazzocchi did a PhD in biomedical engineering at Wake Forest, in the institute that had built tumor organoids carrying the patient’s own immune cells. Katie-Rose Skelly studied computer science, took a master’s in biomedical informatics and went to Utah as a data scientist at Recursion. They met through a mutual friend there.
They applied to Y Combinator in March 2020. “I defended my thesis two days before I had to apply to Y Combinator, the day North Carolina shut down for coronavirus. It was the wildest three days,” Mazzocchi told Fierce Biotech that August.
Y Combinator put in $150,000. Altitude Lab, the incubator Recursion runs with the University of Utah, gave them free bench space, and they outgrew it. By early 2021 the team was four and had moved into Research Park. The company says it closed 2021 with 13 people, hundreds of patient samples processed and millions of images.
The round, then the exit
On August 25, 2021 Known Medicine announced a $7.2 million seed round led by Caffeinated Capital, with Khosla Ventures, Cota Capital, Kickstart, Forward VC, OATV and Y Combinator, plus angels Chris Gibson of Recursion and Nish Bhat of Color.
In April 2022 it posted its validation study to ClinicalTrials.gov: KM3D, up to 2,000 patients, with Mayo Clinic, Duke Cancer Institute and MD Anderson as collaborators and Mazzocchi as principal investigator.
In March 2023 Skelly told Utah Business the team was working toward its first peer-reviewed publication, the paper that would be proof of concept. Two months later, on May 23, 2023, the company announced it had joined Pathos AI, started out of Tempus by Eric Lefkofsky and Ryan Fukushima. Fukushima wrote that day that Pathos had “also acquired and integrated Known Medicine, a company that builds patient-specific 3D cell cultures & uses AI approaches to prospectively predict drug responses in patients.” No terms were disclosed. The paper never appeared.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| Registered study | NCT05338073, KM3D Multicenter Cancer Consortium, sponsor Known Medicine, Inc., protocol KM-20-001. Observational, case only, started Jan 12, 2021, posted Apr 20, 2022, up to 2,000 patients at Mayo Clinic, Duke Cancer Institute and MD Anderson. The Known 3Dx test is recorded as an FDA regulated device that is not approved. | Public record |
| What it was designed to settle | The protocol says hospital outcome data would allow “retrospective validation of tumor organoid sensitivity,” checked at 3, 6, 9 and 12 months. No study was registered in which treatment was assigned by the assay and compared against usual care. Nothing on record prospectively tests whether acting on a prediction helps a patient. | Public record |
| Study status | Last update posted Apr 24, 2023, a month before the acquisition. Status now unknown, last known recruiting. No results posted. | Public record |
| Peer-reviewed validation | None found. PubMed returns two papers with a Known Medicine affiliation, on a stem cell hydrogel and on estrogen receptor signalling. Neither reports platform accuracy. | Not found |
| Accuracy figures | The company said ODIN would “predict how well a patient’s tumor will respond to a specific treatment method before it is prescribed.” No sensitivity, specificity or concordance rate was ever published. | Not found |
| Federal and SEC record | No FDA 510(k) or premarket approval. No NIH or NSF award to the company. No EDGAR filer and no Form D. The seed round rests on a press release, not a Regulation D notice. | Not found |
| Where it went | Pathos AI announced the acquisition May 23, 2023, and has since raised a $365 million Series D at about $1.6 billion post-money. Its 2026 platform page describes a “lab-in-the-loop validation system” and never mentions organoids or 3D cell culture. | Acquirer-stated |
Read plainly: Known Medicine built a real laboratory process, ran real patient samples through it, and signed up three serious cancer centres to feed it tissue. What it never produced, in public, is the number that matters. No paper, no posted result and no accuracy figure shows how often a prediction matched what happened to the patient. The study it registered asked that question retrospectively. The stronger question, whether patients treated by the assay do better than patients treated the usual way, was never put on the record here.
What to watch
- Whether any KM3D data is ever published. The registry entry has not moved since April 2023 and carries no results.
- Whether Pathos AI names the organoid platform in its own scientific or regulatory disclosures. Its 2026 platform page does not.
- Whether NCT05338073 is ever updated, completed or withdrawn.
- Whether anyone in functional precision oncology runs the randomised trial ASCO has asked for since 2004. That, not another platform launch, would move the guideline.
In their words
“I defended my thesis two days before I had to apply to Y Combinator, the day North Carolina shut down for coronavirus. It was the wildest three days,”
Andrea Mazzocchi, co-founder and CEO, Fierce Biotech, 2020 · Independent
“We are adding another tool for physicians to make the best decision. We do that by modeling not just a patient’s cancer cell, but also a bunch of other cell populations,”
Andrea Mazzocchi, Fierce Biotech, 2020 · Independent
“It feels insane to test drugs on people with a coin-flip chance of success,”
Katie-Rose Skelly, co-founder and CTO, Utah Business, 2023 · Independent
“What we’ll be able to show is that we can look at the patient that donated the tissue, see what drug they were given, see how they responded and identify whether that matches what we would have expected,”
Katie-Rose Skelly, on the paper in progress, Utah Business, 2023 · Independent
“A projected 1.9 million Americans will be diagnosed with cancer this year, and current clinical diagnostics based on genetic testing will help less than 10% of patients find the most effective treatment for their cancer,”
Varun Gupta, partner, Caffeinated Capital, seed release, 2021 · Company release
“The use of CSRAs to select chemotherapeutic agents for individual patients is not recommended outside of the clinical trial setting.”
American Society of Clinical Oncology, guideline update, 2011 · Public record
“We are happy to have joined forces with Pathos, an AI-enabled drug development company with the shared goal to improve the lives of cancer patients.”
Known Medicine, company account, May 2023 · Company
Related companies
Sources
- Public recordClinicalTrials.gov NCT05338073, KM3D Multicenter Cancer Consortium
- Public recordASCO guideline update on chemotherapy sensitivity and resistance assays
- Public recordASCO Technology Assessment on the same assays
- Public recordASCO guideline, advanced HER2-negative breast cancer
- Public recordPubMed, NIH RePORTER and SEC EDGAR searches
- IndependentY Combinator startup grows mini-tumors to take the guesswork out of cancer treatments
- IndependentKnown Medicine is using machine learning to cure cancer
- IndependentKnown Medicine Closes $7.2M Seed Funding Round
- IndependentRe-engineering drug development for Precision Medicine
- IndependentPathos AI Secures $365 Million in Series D Financing
- IndependentChanging Cancer Care, One Organoid at a Time
- CompanyKnown Medicine Raises $7.2 Million Seed Round
- CompanyKnown Medicine story, application and home pages
- CompanyPosts on the Pathos acquisition
- CompanyOur Platform, Pathos AI
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
