HAYWARD, Calif., Sept. 27, 2021 /PRNewswire-PRWeb/ -- Predicine, Inc. announces results from a study demonstrating the concordance between their tissue and blood-based liquid biopsy assays, and the clinical application of utilizing the PredicineATLAS liquid biopsy NGS assay to detect somatic mutations and tumor mutation burden (TMB) in patients with metastatic urothelial carcinoma (mUC).
The study presented at ESMO compared the concordance of paired blood and tissue samples in evaluating TMB and somatic variants. The genomic alterations were correlated with clinical outcomes for patients with mUC who were treated with toripalimab (anti-PD-1). The study is entitled "Longitudinal circulating tumor DNA profiling of metastatic urothelial carcinoma in the open-label Phase II POLARIS-03 trial." PredicineATLAS is a 600 gene next-generation assay that evaluates somatic variants and assesses TMB. The assay was utilized at baseline and then every two cycles while a patient was on treatment.
The study found that the TMB calculated from ctDNA in blood samples (bTMB) was in concordance with TMB calculated from matched tumor samples (tTMB). Correlating genomic alterations with clinical outcomes demonstrated that a high level of bTMB prior to treatment predicted response to toripalimab and was associated with increased progression-free survival. Additionally, the study demonstrated that early clearance of ctDNA levels after the onset of treatment was useful in identifying patients who would respond to anti-PD-1 therapy. Of note, two out of three patients with FGFR3-TACC3 gene fusions achieved a partial response.
"This study demonstrates the clinical value of utilizing PredicineATLAS to assess somatic mutations and TMB in patients with metastatic urothelial cancer. Serial monitoring of ctDNA levels can help to more quickly identify those patients who are benefitting from anti-PD-1 therapy," said Dr. Shidong Jia, Founder and CEO at Predicine. "We are pleased to provide a range of next-generation liquid biopsy solutions that may have profound clinical implications including predicting patient survival, selecting therapies for treatment, monitoring for treatment response, and understanding subsequent resistance. Predicine was founded to address unmet clinical needs. Our goal is to detect cancer early, treat early stages of cancer, and improve care for all patients with cancer."
The publications can be found online at: https://www.predicine.com/publications/
Predicine is a molecular insights company in Silicon Valley that is committed to advancing biomarker-driven precision medicine. Predicine has developed a breakthrough cell-free DNA and cell-free RNA based liquid biopsy technology for non-invasive cancer profiling, disease monitoring, assessing minimal residual disease, and early cancer detection. The company has launched a portfolio of blood-based and urine-based assays for solid tumors and hematologic malignancies. Through its CLIA and CAP facilities in the US and China, Predicine partners with leading biopharma companies and hospitals to support global clinical trials, CDx development and personalized cancer care. Further information is available on the company's website, http://www.predicine.com. Stay in touch on LinkedIn or on Twitter @Predicine.
Brian Strike, Predicine, +1 (615) 218-6234, [email protected]