Recent study in the Journal of Urology shows PredicineCARE urine-based liquid biopsy test provides non-invasive molecular profiling for patients with bladder cancer
Results from the study utilizing the PredicineCARE liquid biopsy assay evaluate the concordance of somatic alterations identified by standard tissue testing to those identified by analysis of urinary circulating tumor DNA in patients with urothelial bladder cancer.
HAYWARD, Calif., Sept. 29, 2021 /PRNewswire-PRWeb/ -- Predicine, Inc. announces results from a study demonstrating the concordance between tissue testing and analysis of urinary circulating tumor DNA (utDNA) while utilizing the PredicineCARE liquid biopsy NGS assay to detect somatic cancer variants in patients with urothelial bladder cancer (UBC).
The study published in the Journal of Urology evaluates the concordance between the "gold standard" of tumor tissue DNA (tDNA) with blood circulating tumor DNA (ctDNA) and urinary circulating tumor DNA (utDNA). The study is entitled "Urinary Molecular Pathology for Patients with Newly Diagnosed Urothelial Bladder Cancer." The study utilized PredicineCARE, a 152-gene next-generation sequencing assay that evaluates somatic cancer variants.
The study found that a wide range of quantitative metrics such as cancer cell fraction, variant allele frequency, and tumor mutation burden were concordant between tDNA and utDNA, but not ctDNA. Using tDNA as the gold standard comparison, utDNA analysis achieved a specificity of 99.3%, a sensitivity of 86.7%, a positive predictive value of 67.2%, a negative predictive value of 99.8%, and a diagnostic accuracy of 99.1%. The utDNA assays outperformed ctDNA assays across all these metrics. Of note, the study found that higher levels of preoperative utDNA levels were associated with worse relapse-free survival. Finally, actionable variants, including alterations in FRGR3 and ERBB2 amplification, were identified in utDNA, which could help guide targeted therapies for patients.
"This study demonstrates the clinical value of urine-based liquid biopsy testing to provide a non-invasive and highly accurate option to assess somatic alterations and to identify potential targeted therapies in patients with newly diagnosed urothelial bladder cancer," 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. 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/
About Predicine
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.
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SOURCE Predicine
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