FDA Cleared Platform

Advancing predictive oncology research

Breakthrough therapeutics take too long and cost too much to develop. Most fail before ever reaching patients. Sus Clinicals offers a better way. Our innovative Oncopig® platform uses genetically modified pigs to bridge the gap between mice and human trials. We create tumors and co-morbidities on-demand, allowing researchers to test drugs, devices, and diagnostics in a more predictive and cost-effective way.

Platform
FAQs

100%

Tumor success rate

Across all validated models

1-2

Weeks to measurable tumor formation

0.5-2 cm range

8+

Validated tumor models

FDA-cleared platform

95%+

Histological concordance

With human counterparts

2022

FDA clearance received

Enforcement discretion granted

50+

Peer reviewed publications

Nature, Cancer Research, others

The Oncopig® Platform

Our CRISPR-engineered porcine model enables controlled induction of genetically defined tumors across multiple organ systems. Each model undergoes rigorous molecular and phenotypic characterization to ensure translational fidelity.

"Oncopig tumors were virtually indistinguishable from their human counterparts in blinded pathological examination, demonstrating remarkable histological and molecular concordance."
Nature Biotechnology, 2024 | Schachtschneider et al.
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  • Hepatocellular Carcinoma
  • Lung Adenocarcinoma
  • Colorectal Cancer
  • Glioblastoma
  • Pancreatic Ductal Adenocarcinoma
  • Urothelial Carcinoma
  • Soft-Tissue Sarcoma
  • Renal Cell Carcinoma

Comprehensive Preclinical Solutions

From therapeutic screening to device validation, our platform supports rigorous preclinical evaluation across the full spectrum of oncology research and development needs.

Across all validated models

100%

Tumor success rate

Across all validated models

8+

Validated tumor models

FDA-cleared platform

95%+

Histological concordance

With human counterparts

50+

Peer reviewed publications

Nature, Cancer Research, others

Frequently asked questions

Yes, the Oncopig has been cleared for use by the U.S. Food & Drug Administration. More information is available here.

Our success rate for tumor induction in any test animal is 100%. We do typically induce in multiple sites, to ensure that at least one of the sites generates a tumor.

We typically see tumors of 1-3 cm within two weeks of the tumor induction procedure.

Tumors generated in the Oncopig are virtually indistinguishable from their human counterparts. In blind examination by an expert pathologist, Oncopig liver tumors were identified as a human tumor. Histology, imaging and other assessment tools confirm that Oncopig tumors recapitulate their human counterparts.

Oncopig tumors have been successfully induced in the following:

  • Bladder
  • Brain (glioblastoma)
  • Colon/Rectum
  • Kidney
  • Liver (non-specific and HCC)
  • Lung
  • Pancreas
  • Kidney

Generally yes. Sus Clinicals has an overall quality management system (QMS) and documented procedures in place to allow for conducting many studies under GLP. It is possible that procedures required for a specific study many not have yet been documented via our QMS, and thus would need to be codified and approved, which is generally possible depending on the client’s timing requirements. Note that additional charges apply for conducting studies under GLP.

In order to conduct a range of preclinical testing services via the Oncopig, Sus Clinicals has access to a roster of procedural experts, covering interventional radiology, pulmonology, urology and more. We also have ongoing veterinary care support.

Sus Clinicals has master service agreements with top-tier research institutions, where we conduct preclinical testing services. We also partner with service providers for the breeding and care of our Oncopigs. All of these entities operate under their applicable accreditations or certifications, including the American Association for Laboratory Animal Science (AALAS), the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), and the U.S. Department of Agriculture (USDA). All studies are conducted under appropriate Institutional Animal Care & Use Committee (IACUC) approvals.

Please contact our team and we can arrange an introductory call to discuss your research needs and whether/how our platform can advance your work.