DIAGNOSTICS
product development
Background:
QSOX1 has been confirmed as a biomarker in tissue biopsies for the following cancers: breast, pancreatic, lung, prostrate, melanoma, renal, kidney bladder. Furthermore and very importantly, a consensus is building that QSOX1 over-expression is important during tumor cell invasion, facilitating tumor cell migration at the tumor-stroma interface. As such, QSOX1, in addition to indicating when cancer is present, may be considered a prognostic indicator of metastatic potential.
Objective:
Create a Rapid Diagnostic Test early cancer detection device. This will require developement of three products, which as as follows:
IMMUNOHISTOCHEMISTRY (IHC) DIAGNOSTIC TEST
The Company is developing an IHC test using proprietary anti-QSOX1 polyclonal antibodies and novel monoclonal antibodies. The Company will test top 3-4 proprietary antibodies on different tumor types, utilizing commercial tissue arrays for rapid screening and discovery, and subsequently, collaborate with a Mayo Clinic pathology lab for evaluation.
UNIVERSAL COMPANION RAPID DIAGNOSTIC TEST (COMPANION RDT)
The Company has developed proprietary assays with high sensitivity (300 picograms/ml) for the purpose of detecting QSOX1 levels in patients undergoing cancer treatment. The Company has already tested over 200 bladder cancer samples seeking to establish a correlation of QSOX1 levels with tumor progression/regression. In addition, the Company’s RDT is currently the subject of an ongoing Clinical Trial relating to pancreatic cancer samples. Ongoing testing in vitro and in vivo will continue throughout 2020. The company has signed an agreement with Translational Drug Development, LLC (TD2) to conduct retrospective mouse studies to measure QSOX1 levels in tissue as well as blood as tumors continue to progress. Animal studies to commence 3rd quarter with expected duration of 4-6 weeks.
UNIVERSAL CANCER BIOMARKER
The Company continues research and development relating to QSOX1 with the objective of studying QSOX1 levels in blood at various stages of cancer. QSOX1 overexpression in tissue of cancer patients has been documented in various studies, but additional work is required with the blood of cancer patients to make the correlation of QSOX 1 levels with various cancer disease stages. The ultimate goal is to validate QSOX1 as a blood biomarker for cancer. Various validation studies are planned for 2020 and into 2021. In particular, the company aims to develop a blood-based RDT for tumors that do not have biomarkers, especially aggressive cancers such as triple negative breast cancer using serum samples, including kidney, renal pathology lab for evaluation.