Certis Oncology Solutions, Inc.

Certis Oncology Solutions, Inc. is an oncology company in the Sorrento Valley district of San Diego, California, founded in 2016.^[S1][S2] Its work is built on one model type: orthotopic patient-derived xenografts, in which a piece of a patient tumor is surgically placed at the anatomically correct site in an immunocompromised mouse rather than under the skin.^[S3] The company pairs that with humanized versions for immunotherapy work, a searchable database of its own models, and a laboratory that holds both animal-welfare accreditation and a clinical laboratory certificate.^{[S4][S5][S7][S8]} This profile summarizes what could be confirmed from the company published material, and is explicit about what could not.

Services relevant to US drug developers

Orthotopic patient-derived xenograft studies

The company describes efficacy testing in orthotopic patient-derived xenograft models, abbreviated O-PDX, which the company abbreviates as O-PDX. A small tissue specimen from a patient tumor is engrafted surgically into the anatomically correct place in immunocompromised mice, producing what the company calls avatars of that patient cancer.^[S3] The orthotopic placement is the point of difference from a subcutaneous xenograft: the tumor grows in the tissue environment it came from, which is the argument for using it when the site of growth is expected to matter. Whether that difference changes the answer for a given compound is a question for the study design, and this profile does not evaluate the claim.

Humanized models for immuno-oncology

For immunotherapy programs, the company describes humanized orthotopic patient-derived xenograft models, abbreviated huO-PDX, as relevant to solid tumor immunotherapies and to mechanisms directed at the tumor microenvironment.^[S4] Support for evaluating cell therapies directed at solid tumors is described alongside this work.^[S4] Sponsors should confirm which human immune components are reconstituted in a given model and how they are sourced, since that determines what an immunotherapy readout in such a model can and cannot show.

Model library and database

Certis maintains a bank of patient-derived xenograft models and cancer cell lines with molecular characterization data, published through an online database it launched in October 2022 under the name BarneyOI.^[S5] The size of the collection is stated differently at different dates. An announcement in November 2023 cites a library of more than 450 characterized tumor models,^[S4] while the database announcement a year earlier describes hundreds of models and cell lines.^[S5] Both figures are given here with their dates; no current authoritative count was found in the sources reviewed. Sponsors selecting a model should ask for the passage number, the consent status and the molecular annotation of the specific model rather than relying on a library total.

Predictive analytics

The company markets a machine learning platform, CertisAI, which it describes as generating drug response predictions from gene expression signatures for model selection and as informing both preclinical model selection and clinical trial enrollment criteria.^[S4][S9] In February 2025 it announced that the United States Patent and Trademark Office had allowed a patent application covering the platform, with protection stated to run to March 2043.^[S9] This profile did not verify the current status of the application in the patent register, and the grant status was not checked against patent office records for this profile, so the platform is described here as the subject of an allowed application rather than as patented. The company own announcements also give different launch dates for the platform, so no launch date is stated here.

Quality, compliance, and animal welfare (as stated by the company)

Certis states that it was awarded AAALAC International accreditation in June 2022 and that it obtained an Animal Welfare Assurance with the Office of Laboratory Animal Welfare in February 2022, giving the assurance number D22-01133.^[S7][S8] The page carrying that number labels it an insurance identifier, which appears to be a typographical error, and it is reproduced here as written.^[S8] AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,^[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;^[R4][R5] none of these establishes GLP compliance, which applies to individual studies.^[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.^[R6] No GLP statement, USDA registration statement, or reference to an Institutional Animal Care and Use Committee was found in the sources reviewed for this profile.^[S1][S2] Given that the main service pages could not be read, sponsors requiring a GLP study should ask the company directly rather than treating the absence as an answer.^[R2]

Separately from animal work, the laboratory holds a certificate under the Clinical Laboratory Improvement Amendments, which the company states it has held since 2018 and recertified in November 2024 following an inspection with no deficiencies.^[S2][S7] That certificate governs testing of human specimens for clinical purposes and applies to laboratory testing of human specimens for health assessment or diagnosis. It is a different regime from the Good Laboratory Practice regulations that apply to nonclinical safety studies,^[R2] and one does not substitute for the other. For a sponsor, the practical relevance of the clinical certificate is that human specimens can be handled in the same laboratory as the animal models.

Company facts