SAN FRANCISCO--(BUSINESS WIRE)--IncellDx announces the patent filing with the USPTO and the Pre-EUA with the FDA for CCL5/RANTES Utility as a Diagnostic, Prognostic, and Therapeutic Biomarker in COVID-19. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of a novel coronavirus disease 2019 (COVID-19), is now a global pandemic. Growing information has demonstrated that a dysregulated and/or hyper-immune response causes a “cytokine storm” with massive increases in cytokines and chemokines which leads to infiltration of immune cells in multiple organs driving the significant co-morbidity and mortality in severe COVID-19. CCL5/RANTES is a chemokine that binds to the chemokine receptor CCR5. CCR5 is expressed on immune cells such as T-lymphocytes, macrophages, and NK cells. CCL5/RANTES acts like a magnet for these cells expressing CCR5. Thus CCL5/RANTES is a marker for the early stages of immune dysregulation in COVID-19 and as a possible therapeutic marker to determine when and how long therapy targeting CCR5 or RANTES should be continued. Other Cytokines included in the COVID-19 Cytokine Panel can be used to monitor other COVID-19 therapeutic approaches targeting other cytokines involved in the cytokine storm.
Dr. Bruce Patterson, chief executive officer of IncellDx, commented, “When we were developing a cytokine quantification assay for possible COVID trials in China, we discovered that infected patients had consistently high levels of CCL5/RANTES in plasma which in some cases was 100 times normal depending on the severity of the disease. Other reports in the literature demonstrated that CCL5/RANTES can be elevated in renal failure, liver failure, coagulopathies, and in Kawasaki’s disease, all co-morbidities seen in COVID-19. Therapies targeting CCR5 are currently in trials against COVID-19 and we are extremely excited about filing an initial inquiry with the FDA concerning the potential use of a battery of companion tests to monitor the efficacy of drugs in the fight against this virus. It makes sense that we have diagnostics for the presence or absence of virus, exposure to the virus, and the next round of diagnostics should be personalized medicine approaches to determining the efficacy of COVID-19 therapies.”
Dr Patterson is the primary author of the pre-print Disruption of the CCL5/RANTES-CCR5 Pathway Restores Immune Homeostasis and Reduces Plasma Viral Load in Critical COVID-19 currently undergoing peer review.
Company files Pre-EUA with FDA for CCR5 receptor occupancy and a COVID cytokine panel including IL-6, IL-8,TNF-a, GM-CSF, and CCL5/RANTES.