Shihe Gene Achieves Perfect Score in CAP Certification, Joining Global Elite in Genomic Testing

As the life and health industry experiences rapid growth, gene sequencing technology—the key to unlocking life’s “code”—is increasingly becoming part of everyday life. Recently, Geneseeq, based in the Nanjing High-Tech Zone Bio-Medicine Valley, announced that it had passed the inspection and accreditation of the College of American Pathologists (CAP), an internationally authoritative clinical laboratory quality certification system, with a rare flawless perfect score.

Obtaining CAP accreditation from the United States means that the test reports issued by Geneseeq’s clinical laboratory will have global comparability and mutual recognition, indicating that its gene sequencing laboratory is entering the ranks of world-class facilities.

Geneseed Biotech, founded in 2013, is a cancer genetic testing service company. As early as 2008, the company began applying next-generation high-throughput sequencing (NGS) to research in personalized medicine. It has completed high-throughput sequencing for over 15,000 tumor tissue samples and 5,000 ctDNA samples, establishing itself as a representative enterprise in China’s fields of tumor high-throughput sequencing and ctDNA liquid biopsy. In June 2016, the company secured Series B financing, with its Series A investors increasing their investment by RMB 30 million, and an additional RMB 30 million coming from Oriental Venture Capital and Oriental Fund.

The company is dedicated to the clinical translation and scientific research of “precision medicine” in oncology. It has established multifaceted collaborations with 150 top-tier hospitals across China and several internationally renowned pharmaceutical companies, and operates R&D centers in Nanjing (China), Toronto (Canada), and Stanford (USA). Headquartered in Nanjing, China, the company’s laboratory and office spaces cover a total area of over 6,000 square meters. According to Zhao Minchao, Chief Operating Officer of Geneseeq Technology, their laboratory utilizes the state-of-the-art Illumina HiSeq X10 “super” sequencing platform, which can sequence the entire genome of a healthy individual in just three days at a cost of only $1,000.

In the second half of last year, Geneseeq participated in the College of American Pathologists’ (CAP) first-ever global proficiency testing for high-throughput gene sequencing. The assessment evaluated the detection capabilities of 135 leading genetic testing laboratories worldwide across nearly 100 mutations in 15 genes commonly associated with solid tumors. Geneseeq successfully passed all three certifications with outstanding results, “indicating that our quality control standards and sequencing technologies have reached internationally advanced levels.” In addition, Geneseeq has also passed multiple high-throughput sequencing proficiency assessments conducted by the European Molecular Genetics Quality Network (EMQN) and the National Center for Clinical Laboratories (NCCL) under the Chinese Ministry of Health.

CAP is the world’s premier medical laboratory accreditation organization, and CAP accreditation is internationally recognized as the most suitable laboratory standard for clinical testing laboratories worldwide. BGI Genomics obtained this accreditation as early as July 2015, and Yizhen Biology successfully passed the assessment this February. Gene+’s recent perfect-score passage of the accreditation signifies that its sequencing laboratory has reached a leading level. It is reported that the CAP headquarters will soon issue the official certificate of accreditation to Gene+.

Source: China Pharmaceutical Network