HAYWARD, Calif., April 05, 2024 (GLOBE NEWSWIRE) — Predicine, Inc., a leading molecular insights company, announced the release of its innovative PredicineCARE™ NGS Kit. This offering presents a research-use-only (RUO) next-generation sequencing (NGS) kit packaged for genomic profiling across various cancers, facilitating global applications in clinical trials, companion diagnostics (CDx) development, and patient testing.
The PredicineCARE™ NGS assay was granted Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) on August 23, 2022. This newly introduced PredicineCARE™ NGS kit integrates a comprehensive, state-of-the-art NGS assay capable of detecting point mutations, indels, fusions, amplifications, and deletions in key cancer-associated genes. It harnesses cell-free DNA (cfDNA) from liquid biopsy samples such as blood and urine, along with genomic DNA from FFPE tissues.
“We are delighted to present the PredicineCARE™ NGS Kit specifically tailored to address the evolving needs of pharmaceutical companies and testing laboratories seeking decentralized lab testing options,” said Dr. Shidong Jia, Predicine’s Founder, Chairman, and CEO. “Predicine’s centralized global lab network coupled with the decentralized kitted offering provides a standardized approach to support clinical trials, CDx development and patient testing on a global scale.”
About PredicineCARE™ NGS Kit
The PredicineCARE™ NGS Kit comprises a comprehensive, state-of-the-art NGS assay that interrogates point mutations/indels, fusions, amplifications, and deletions in key cancer-associated genes using cell-free DNA (cfDNA) from liquid biopsy samples such as blood and urine, along with genomic DNA from FFPE tissues. The PredicineCARE™ NGS Kit is coupled with sequencing data analysis software.
About Predicine
Predicine is a leading molecular insights company committed to advancing precision medicine in oncology. Predicine has developed a proprietary cell-free DNA and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection. The Predicine portfolio comprises state-of-the-art blood, urine, and tissue-based Next-Generation Sequencing (NGS) assays designed for harmonized global use in research, clinical development, companion diagnostic (CDx) development, and patient testing. With operational hubs in Silicon Valley, Houston, Chicago, and Shanghai, Predicine collaborates with leading biopharma companies, institutions, and governments in personalized healthcare on a global scale. For more information, please visit us on http://www.predicine.com and follow us on LinkedIn or Twitter (X).
Contact Information:
Predicine, Inc.
[email protected]
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/28ffe620-866f-47fd-9028-dad9d75f9f82
