Besides, given GBM's heterogeneity, I am not sure it's clear which cells you are growing and how representative they are.
Is this FDA-approved?
We started with the basis that all brain cancer patients receive a standard of care that will do little to extend their lives. Only about 10% enroll in clinical trials in the US, which only test one drug at a time. Most of the clinical trials are performed on patients who have a regrowth of their tumor, which has little chance of responding to treatment.
309 Currently Open Trials for Glioblastoma, but only 75 for newly diagnosed patients. https://clinicaltrials.gov/ct2/results?term=glioblastoma&rec...
With 90% of the patients not enrolled in a clinical trial we wanted to design a commercial solution that could help patients today rather then relying on the standard of care.
We have collaborations with academic labs that are studying the heterogeniety of neurospheres cultured from multiple sites from the same patient's tumor. Ideally to get a more representative sample you would be able to obtain multiple samples from the same patient and derive a separate culture from each one.
We will not be seeking FDA approval for our service as it is not a drug or diagnostic for a disease. The pathway for us is as a CLIA certified service similar to other personalized genomics companies in cancer like Foundation Medicine.
Clinical trials in the US test drug combinations and not just single drugs.
> With 90% of the patients not enrolled in a clinical trial we wanted to design a commercial solution that could help patients today rather then relying on the standard of care.
In other words, you are enrolling them in your own clinical trial without calling it such. Clinical trials are not perfect, but it's the best way we have to guarantee safety and efficacy.
> The pathway for us is as a CLIA certified service similar to other personalized genomics companies in cancer like Foundation Medicine.
Actually, it's very different. Foundation Medicine looks for known genetic variants and offers suggestions based on those. It is not offering novel or untested solutions. Their report is actually very poor if you are looking to make new discoveries.