Predicine’s Liquid Biopsy Next-Generation Sequencing (NGS) Assay is Granted Breakthrough Device Designation by U.S. Food and Drug Administration
SILICON VALLEY, Calif., (September 20, 2022) – Predicine, Inc., a global molecular insights company committed to advancing precision medicine in oncology and infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation to the PredicineCARE™ cfDNA Assay, a Next-Generation Sequencing (NGS) assay for tumor mutation profiling in cfDNA isolated from liquid biopsy samples from cancer patients.
The PredicineCARE cfDNA Assay is a comprehensive CLIA-validated assay that targets variants in 152+ genes, including single nucleotide variants (SNVs), insertions and deletions (indels), DNA re-arrangements (fusions), and copy number variations (CNVs) that are known to be clinically relevant. The PredicineCARE cfDNA Assay is being developed to identify biomarker-eligible cancer patients with select indications who may benefit from treatment with targeted therapy.
“We are excited about FDA’s decision to grant Breakthrough Device designation to the PredicineCARE cfDNA Assay,” said Shidong Jia, Predicine’s Founder and Global CEO. “This is a significant milestone achievement in our journey to advancing liquid biopsy precision medicine and accelerating accessibility for cancer patients. We look forward to further developing the PredicineCARE cfDNA Assay as a potential companion diagnostic test under the Breakthrough Devices Program.”
The FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.[1]
About Predicine
Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology, and infectious disease diagnostics. 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. Reach out to us at media@predicine.com.
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Predicine, Inc.
media@predicine.com
[1] https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#s1