Predicine Establishes Dual CAP Accreditation for its Genomic Sequencing Laboratories in US and China to Support Global Clinical Trials

Thursday, October 18, 2018 General News
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Predicine has established a unified global quality management system through its CAP/CLIA facility in the San Francisco Bay Area and CAP facility in Shanghai, China to offer cross-border harmonized biomarker assays for global clinical trials.

HAYWARD, Calif., Oct. 18, 2018 /PRNewswire-PRWeb/ -- Predicine, a molecular insights company, announced today that its

CLIA-certified genomic sequencing laboratory in the San Francisco Bay Area has received accreditation from the College of American Pathologists (CAP) for meeting the highest standards in quality, operations, and patient safety.

Predicine received CAP accreditation for its Shanghai facility last month. The current dual CAP accreditation of its laboratories in U.S and China enables the company to offer harmonized biomarker assays to its biopharma partners to support clinical trials in China and worldwide. In this setting, all patient samples collected in China will be locally processed in the Shanghai laboratory and samples collected outside of China will be shipped to and processed in the Hayward, California laboratory.

"The dual distinction of being CLIA-certified and CAP-accredited demonstrates our commitment to uphold the industry's most stringent requirements in laboratory testing for our harmonized assays," said Dr. Shidong Jia, Founder and CEO of Predicine. "Gaining identical CAP accreditation for both our Shanghai and Hayward facilities enables us to provide a unified quality management system to fully support our partners' global clinical trials."

Predicine has developed a propriety GeneRADAR liquid biopsy technology to detect genetic cancer variants in circulation using blood and urine samples. Most recently, Predicine launched an RUO 600-gene TMB liquid biopsy panel at AACR and partners with world-leading biopharmaceutical companies to support global clinical trials in U.S., Europe, Australia, and China.

About Predicine

Predicine is a molecular insights company that is committed to developing the best-in-class precision diagnostics and precision medicine portfolio to address the unmet medical needs worldwide. Predicine's proprietary GeneRADAR technology is the industry's first ctDNA+ctRNA combo liquid biopsy test to provide a comprehensive understanding of the molecular alterations in cancer. Through its integrated one-stop biomarker service facilities in US (California) and China (Shanghai, Harbin), Predicine partners with leading biopharma companies and hospitals to support global clinical trials, early cancer screening, and targeted therapy. For more, please visit predicine.com and follow Predicine on Twitter @Predicine.

 

SOURCE Predicine



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