Personalized in vivo testing is a two-phase, multi-step process.
Phase One: Study Initiation
The purpose of the Study Initiation phase is to establish human tumor tissue in immunocompromised mice, and to expand (grow) adequate tissue volume to support a Pharmacology Study. Depending on the size of the sample that Certis receives, the individual’s tumor tissue will be implanted in up to five (5) immunocompromised mice, usually in multiple anatomic (relating to anatomy) locations to increase chances of successful establishment. This first cohort (group) of mice is referred to as the F1 generation. In some cases, particularly in those involving slow-growing tumors, a second passage ( re-implantation into new hosts) may be required to create sufficient tissue volume. This involves harvesting tumor tissue from F1 generation mice and engrafting it into a second cohort of mice (the F2 generation).
Phase Two: Pharmacology Study
When Study Initiation is successful, Certis can proceed to the second phase of testing: the Pharmacology Study. This involves developing a sufficient number of orthotopically engrafted mice to support the agreed-upon study design, then dosing orthotopic patient-derived xenograft (O-PDX) mouse models with selected therapies to simultaneously evaluate tumor response to in each.