SILICON VALLEY, Calif., Aug 09, 2022 / Predicine, Inc., a global molecular insights company, has launched its CE-marked PredicineCARE™ for genomic profiling in blood and urine. The PredicineCARETM cell free DNA (cfDNA) assay is a targeted Next-Generation Sequencing (NGS) assay for the detection of single nucleotide variants (SNVs), insertions and deletions (Indels), DNA re-arrangements (fusions) and copy number variations (CNVs) in patients diagnosed with cancer.
PredicineCARE™ is a comprehensive CLIA-certified liquid biopsy assay that targets 152 genes, including guideline recommended gene targets that are known to be actionable and linked to available therapies or clinical trials. PredicineCARE™ has been utilized by leading biopharmaceutical companies and key opinion leaders (KOLs) in global clinical trials, patient testing and the development of companion diagnostics (CDx).
With this CE mark, Predicine can provide PredicineCARE™ as a commercialized in vitro diagnostic (IVD) in the European market. PredicineCARE™ is the first urine-based cfDNA assay that is characterized by exceptional analytical performance and thus will provide great value to patients in Europe.
“Launching PredicineCARE™ as the first CE-IVD marked product is a significant milestone and aligns with the organization’s strategy to provide affordable and accessible molecular testing solution in the European Market” said Shidong Jia, Predicine’s Founder and Global CEO.
Predicine will be attending the 2022 European Society for Medical Oncology (ESMO) conference (booth #454) in Paris, France from September 9th to September 13th to present 4 abstracts and other key data on the company’s liquid biopsy
Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology and infectious diseases. Predicine is developing proprietary cell-free DNA- and cell-free RNA-based liquid biopsy technologies to enable minimally invasive molecular diagnosis for early cancer detection, treatment selection, therapy response, minimal residual disease monitoring and disease progression. The Predicine portfolio includes blood-, urine-, and tissue-based NGS assays designed for global harmonized use in research, clinical investigation, and CDx development. Through its business operations in Silicon Valley, Houston, Chicago, Los Angeles, Boston, Shanghai, Berlin, Singapore, Beijing, Suzhou, and Harbin, Predicine is partnering and collaborating with leading biopharma companies, institutions, and governments to support personalized healthcare on a global scale. Further information is available on the company’s website, http://www.predicine.com. Stay in touch on LinkedIn or @Predicine on Twitter.