Cellgen will initially offer its EVAP (patent pending) technology as an LDT based, bio-analytical service to its partners that can be transitioned into assays that run on an FDA-approved PoC IVD if the therapeutic is approved through the various trial stages. The Cellgen business model allows trial sponsors to develop companion diagnostics at a pre-clinical stage without the concern of wasting millions of dollars due to early phase therapeutic failure. Cellgen’s EVAP (patent pending) technology’s competitive advantage lies in its low complexity, low cost and speed to result technology that is ideal for existing PCR and NGS assay developers to retrofit their assays to run on the biomarker agnostic EVAP platform. Cellgen is committed to developing its EVAP (patent pending) technology as the first in-house cancer diagnostic platform that will disrupt the field of personalized medicine.
Cellgen aims to become the partner of choice for small CRO organizations that are looking to gain a competitive edge or a medium/large CRO that has it’s own laboratory operations but could benefit from placing a single IVD platform at clinical tests sites in order to receive patient selection decisions at the point of care. Cellgen has a centralized laboratory with established best practices for running liquid biopsies because it’s difficult for multiple laboratories to have the same knowledge base from which to manage time-sensitive bio-fluids on new liquid biopsy platforms. Cellgen will adopt GxP and CLIA certified protocols and SOPs to ensure consistency in all aspects of sample handling processing storage and results interpretation.
Notwithstanding, Cellgen will also develop a portfolio of stand-alone diagnostic assays across a diverse set of major disease indications. Liquid biopsies are aggressively addressing the barriers of adoption for current molecular technologies and may help to revolutionize cancer research, patient treatment and survivor care.
The industry is expected to grow exponentially because of the breadth of potential cancer applications, which when considered with non-cancer applications, such as infectious disease, central nervous system, cardiovascular disease and inflammation is projected to grow beyond $10 billion by 2020. With Cellgen’s technology designed to run hundreds of different DNA and RNA based assays, the company’s future viability is exceptionally robust.