Many novel pharmaceutical compounds fail late during drug development, because of in vivo genotoxicity and subsequent carcinogenicity in animal studies. Ideally, such compounds are already discarded early during drug development. However, the battery of assays currently available for detecting genotoxicity early during drug development gives inconsistent results and are very bad at predicting in vivo genotoxicity and carcinogenicity. These doubtful conclusions cost the pharmaceutical industry a lot of money, time, and frustration, as they trigger additional in vitro and animal testing, or the discontinuation of a novel drug without truly knowing its genotoxic potential.
GenomeTOX offers a single and rapid assay, based on whole genome sequencing and artificial intelligence-based mutational analyses of primary human hematopoietic stem cells, which assesses all types of genotoxicity across the entire DNA. We have unique expertise in analysing the genomes of human stem cells and our academic research group was the first to describe how lifelong mutation accumulation in different tissues contributes to carcinogenesis. At GenomeTOX, we use umbilical cord blood-derived stem cells, which have an extremely low background mutation burden and are therefore ideally suited to assess even the smallest genotoxic effects of tested compounds. We validated our assay on a compendium of antiviral compounds and show that our assay perfectly overlaps with in vivo carcinogenicity studies in rodents. Our assay can therefore, already early during drug development, predict if novel drugs will fail later in the process of drug development, saving our costumers the frustration of performing costly and time-consuming animal studies on drugs that will fail anyway. We have filed a patent application to protect the intellectual property of our assay.
The long-term vision of GenomeTOX is to become the one-stop-shop for genotoxicity testing and carcinogenicity prediction. Our knowledge on genome-wide mutation patterns allows us to infer mutagenic mechanisms and make predictions about how to modify compounds to lower their genotoxic potential. We are a multidisciplinary team, consisting out of an internationally leading genome biologist, computational and clinical scientists as well as a nutrition scientist with commercial start-up experience.
We require a minimal investment of €300,000 to start up and acquire paying consumers. We envision to break even 3 years after start and to reach a revenue of over €30 million 7 years after our start.