Providing applications throughout the drug development continuum
The Cellgen Platform provides value to our partners throughout the development
continuum. Initially provided as an LDT based service and then as an FDA approved IVD
Liquid biopsy technology within oncology research has applications across the entire drug development continuum… from screening patients for clinical trial enrollment and selecting treatments, to monitoring therapeutic effectiveness such as drug resistance or tumor growth, to guiding therapy decisions and disease recurrence post treatment, and ideally, to finding cancers in their most embryonic stages.
Cellgen’s EVAP (patent pending) technology extends its business model beyond the drug development continuum into providing Point of Care (PoC) based companion diagnostics in partnership with its sponsoring partners.
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. No other liquid biopsy provider in the industry has a product roadmap that includes a PoC IVD.
Historically, multiple barriers to entry have limited the commercial success of molecular PoC diagnostics, such as price points, technical complexity, invasiveness and the ability to develop a broad menu of diagnostic tests to run on a single platform. Cellgen’s EVAP(patent pending) technology will remove those entrance barriers with its low complexity, low cost and near real-time technology that is suited to become an “in house” companion diagnostic platform.
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.