Certis PDX Solutions for Oncologists
Optimizing Patient Outcomes
Certis Oncology provides the world’s only orthotopic xenografts. These Orthotopic PDX models are proven to be the most clinically relevant PDX’s, enabling oncologists to personalize treatments.
Orthotopic PDX has been validated as the fastest and most accurate route to discovering the right drug for the patient. Our mouse models are proven to accurately reflect human metastasis, enabling positive outcomes.
A drug against metastasis provides clinical value.
In the largest STS Orthotopic PDX study to date, we demonstrated a 62% ER among untreated high-grade tumors with a median establishment time of 54 days. Neoadjuvant therapy, particularly radiation, and pathologic response to treatment were associated with a reduced rate of Orthotopic PDX establishment.
- Orthotopic PDX avoids the possible false positives and false negatives due to the tumor growing ectopically (the wrong place)
- Orthotopic PDX allows the potential to test drugs against metastasis, which appear to have a different drug response pattern than the primary tumor.
- We can help identify the ideal patient population for different drugs.
Concordance has been validated.
With Orthotopic PDX, what happens in the patient happens in the mouse. The technique has a very high genetic and histo correlation to the patient’s tumor. We typically see 3-4 months or faster establishments (vs 6-9 months for PDXs). The earlier we get patient tissue, the better we can address the 2nd line therapy (1st line is typically Standard of Care).
The Orthotopic PDX offer for oncologists and their patients.
Once we obtain your patient’s tumor, we will surgically implant it in our immuno deficient mice. Once the tumors grow, we will passage them multiple times to insure future growth [per our validated model]. We can use core needle biopsies or surgical samples.
After mouse implantation, we will cryo preserve these tumors. At any time, should the Standard of Care Therapy fail, they can be taken out of cryo, regrown in mice and used for future testing.
The benefit to you.
Certis Oncology will test patient tumors in animal models to determine the best course of therapy. These models simulate the human condition better than PDXs, due to our Surgical Orthotopic Implantation technique. The results are faster than other available models.
We have our vivarium and tumor bank on premises. Our lab is being prepped for compliance with CLIA [Clinical Laboratory Improvement Amendments]. Our immortalized tumors are in cryo-preservation in our lab.
Requirements: Certis Oncology requires patient consent, for which we provide forms. We are compliant with HIPPA privacy and confidentiality regulations.
Reasonable cost: Orthotopic PDX pricing is more reasonable than competitors. We will only charge if we have success implanting so we can proceed to testing.
IND Precedent: The Orthotopic PDX methodology is conducive for INDs. We leveraged our modeling data to obtain an IND at UCLA. This IND was for a drug not on the market. Through the data we collected, we obtained permission for compassionate use of a drug not yet FDA approved. The drug was highly effective for the patient.