Veterinary oncology · Precision medicine
FidoCure
A tumor sequencing service that routes dogs with cancer toward human targeted therapy drugs, compounded to canine doses. Four peer reviewed papers, one US patent, and no FDA approved animal drug of its own.
The dog that started the pitch deck
In 2018 Kathy Guptill came home to find her eleven year old Maltipoo, Lulu, limping. The diagnosis was myxosarcoma, a high grade soft tissue cancer, and the left hind leg came off. Lulu’s oncologist, Aarti Sabhlok, sent the biopsy tissue to a startup called One Health. It came back with a map of the mutations in the tumor and a list of human cancer drugs matched to them. One drug Sabhlok would have reached for first turned out to be a poor fit.
“They use gene mapping, they give me the receptors and the drugs that are gonna work against those receptors,” Sabhlok told CNBC in April 2019. She had used the service on eight patients in twelve months. By December she was an advisor, holding stock.
One approved drug, for one cancer
In 2009 the FDA approved Palladia, a tyrosine kinase inhibitor from Pfizer, for canine cutaneous mast cell tumors: the first drug developed specifically to treat cancer in dogs. Bernadette Dunham of the FDA said at the time that “Prior to this approval, veterinarians had to rely on human oncology drugs, without knowledge of how safe or effective they would be for dogs.”
Seventeen years later the shelf is still nearly bare. Writing in dvm360 in 2022, veterinary oncologist Mona Rosenberg noted that more than 200 targeted therapies have FDA approval in human medicine, and “In veterinary medicine we are way behind with only 2 drugs (Palladia and Apoquel) to target disease in dogs.” Roughly six million US dogs are diagnosed with cancer each year, and fewer than 500 board certified veterinary oncologists practice.
A private equity director and a vet school dropout
Christina Lopes and Benjamin Lewis met in Sao Paulo in 2012. She was a managing director at Cerberus Capital; he ran a distributor of veterinary supplies in Brazil. They married in 2013 and founded One Health in 2016. Reports differ on where: Forbes says San Francisco, CFI says Philadelphia before a 2017 move to Palo Alto. Y Combinator followed in Winter 2018.
Lopes lost her father to terminal lung cancer. Lewis, a former US Olympic team kayaker, lost a dog to cancer. Andreessen Horowitz, which led the seed round, described Lewis as a bioengineer turned veterinary school dropout, and he has said he intends to finish the degree. A 2022 CFI profile called him a vet, which the record does not support.
The framing Lopes uses is reciprocity. “Everything’s tested on the dog for the human R&D paradigm,” she told Forbes in 2020. “And it never comes back. So the dog remains the subject in this arc.”
How the drugs actually reach the dog
FidoCure sequences 48 cancer genes from fixed tumor tissue in a CLIA certified laboratory and returns a report to the veterinarian. It does not make drugs and it does not prescribe. The therapies are small molecule inhibitors approved by the FDA for people: imatinib, lapatinib, sirolimus, sorafenib, trametinib, vorinostat, dasatinib, toceranib, palbociclib, olaparib.
Prescribing a human drug to a dog is lawful: the Animal Medicinal Drug Use Clarification Act of 1994 permits extralabel use by a veterinarian inside a valid relationship with client and patient. But a dog cannot swallow a human tablet, so the drugs are remade at canine doses by a compounding pharmacy. Ben Lewis named the partner in 2020: “We work with Wedgewood Compounding Pharmacy.”
That last step is where a distinction matters. FDA’s Center for Veterinary Medicine is unambiguous on whether a compounded animal drug is approved. Its answer is no. Even when a compounder starts from an approved drug, the agency says, “the resulting product is not FDA-approved.” Compounding from an approved finished drug is permitted under the extralabel rules. Compounding from a bulk drug substance is a stricter regime, covered by Guidance for Industry 256 of April 14, 2022, under which the product is an unapproved drug that FDA may decline to act against only in described circumstances, and only with a patient specific medical rationale from the veterinarian. Which source material FidoCure’s pharmacies use is not documented publicly.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| Pan cancer outcomes paper | npj Precision Oncology, Jan 19, 2023. Survival for 2,119 dogs, genomics for 1,108, treatment data for 792. Retrospective Cox modeling, no untreated control arm. Four gene and drug pairs reach hazard ratios below one, each on small numbers. | Public record |
| Hemangiosarcoma paper | Scientific Reports, May 14, 2025. 508 dogs after splenectomy. Median survival 211 days for surgery plus chemotherapy plus targeted therapy, 149 days for surgery plus targeted therapy, 81 days for surgery alone. Retrospective, and the authors discuss the risk that adjuvant therapy only reaches dogs who live long enough to get it. | Public record |
| Mutation landscape paper | Scientific Reports, Jul 6, 2023. 671 dogs, 23 tumor types. TP53 mutated in 22.5% of tumors. Hotspots shared with human tumors in PIK3CA, KRAS, NRAS, BRAF, KIT and EGFR. Descriptive, not a treatment study. | Public record |
| Prospective or randomized trials | None registered. Trial registry searches returned no FidoCure or One Health Company entries as of Sep 23, 2026. | Not found |
| FDA approved animal drug | None. No new animal drug approval, no conditional approval, no index listing. In August 2024 the company said it would seek FDA approval for products. | Public record |
| Marketing language on approval | The veterinarian page states that “Recommended therapies are FDA-approved.” FDA says a compounded animal drug is not FDA approved, and one made from a bulk substance “is not equivalent to an FDA-approved drug, even if they contain the same active ingredient.” The molecules are approved for humans. The compounded canine product is not. | Differs from FDA |
| Patent | US Patent 12036281-B2, granted 2024, on a mutation guided approach to canine bladder cancer. Lopes and Lewis named as inventors. Eight applications reported pending. | Public record |
| Network size | Figures do not reconcile: more than 200 vets in all US states (2020), about 200 in 32 states (2022), 1,350 clinics (2024), 143 clinics and 180 oncologists (accelerator profile). | Company-stated |
| Independent field assessment | A September 2026 review in Veterinary and Comparative Oncology, by authors at Colorado State, TGen, Natera and Vidium, finds genomic testing in veterinary oncology “remains underdeveloped, with limited standardisation, sparse species-specific validation.” | Independent |
| Commercial partners | IDEXX Reference Laboratories began offering the test to US and Canadian clients in January 2022. Thrive Pet Healthcare, more than 350 clinics, signed in June 2022. VolitionRx names One Health Company (Fidocure) as a veterinary competitor in its annual reports, 2022 through 2026. | Public record |
Read plainly: the biology is real and the genomics are solid. The treatment claims rest on retrospective analyses of the company’s own customers, where the dogs who got targeted therapy are the dogs whose owners could pay. The 2025 hemangiosarcoma paper is the strongest result on record. What does not exist is a randomized comparison. Until one runs, the survival numbers are a signal, not a finding.
What to watch
- Whether the patented bladder cancer therapy enters the FDA pathway. Expanded conditional approval is the plausible route: it allows sale for up to five years on a reasonable expectation of effectiveness while substantial evidence is assembled.
- Any prospective controlled study. Every outcomes paper to date is retrospective.
- Whether the source material for the compounded drugs is disclosed, which determines whether GFI 256 applies.
- A Series B. The last announced round closed in October 2020.
In their words
“There is a spirit of the intention of it being a bit safer, gentler and more efficacious. Of course, it’s still cancer therapy, not Advil.”
Christina Lopes, founder and CEO, CNBC, April 2019 · Independent
“they’re all human FDA approved cancer therapies that we’ve brought back into the veterinary space via one of our partners that’s a compounding pharmacy”
Ben Lewis, co-founder, Dog Cancer Answers, 2020 · Interview
“So we don’t have good studies that show the positive or the negative effects. We have some good anecdotal reports, but we really need some large, well done studies to understand if this is an improvement of care.”
Nancy Reese, DVM, who had not used the service, Dog Cancer Answers, 2020 · Independent
“Precision medicine is certainly the wave of the future, but I think right now we’re still in information gathering phase. So I don’t want to add any quote, false hope for guardians.”
Nancy Reese, DVM, Dog Cancer Answers, 2020 · Independent
“Bladder cancer in dogs is an unmet need as traditional chemotherapy and radiation therapy are often ineffective, cause toxic side effects, and are expensive.”
Gerald Post, DVM, chief medical officer, August 2024 · Company release
“And being just sort of giddy that, you know, finally somebody was getting it.”
Mona Rosenberg, DVM, on her first conversation with Lewis, Forbes, October 2020 · Independent
Related companies
Sources
- Public recordCanine cancer mutations and treatment outcomes, 2119 dogs
- Public recordGenomic biomarkers and outcomes in canine hemangiosarcoma
- Public recordShared hotspot mutations in oncogenes in canine tumors
- Public recordAnimal Drug Compounding and Q&A on GFI 256
- Public recordConditional Approval Explained
- Public recordUS Patent 12036281-B2
- Public recordVolitionRx Limited annual reports on Form 10-K
- IndependentCritical Questions in Genomic Diagnostics for Veterinary Oncology
- IndependentSilicon Valley start-up makes dog cancer treatment more precise
- IndependentThe married couple who raised $10 million for dog cancer
- IndependentPrecision medicine: a new frontline attack on canine cancer
- IndependentFDA approves Palladia for mast-cell tumors in dogs
- InterviewWhat is FidoCure? Ben Lewis, with Nancy Reese and Trina Hazzah
- IndependentChristina Lopes, One Health Company CEO and co-founder
- CompanyThe One Health Company seed announcement
- CompanyFidoCure website: About, For Veterinarians, FAQ, press disclaimer
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
