EVRY, France--(BUSINESS WIRE)--Regulatory News:
IntegraGen (FR0010908723: ALINT - PEA-SME Eligible) (Paris:ALINT), a company specializing in the decoding of the human genome with a focus on producing interpretable genomic analyzes for academic and private laboratories and developing diagnostic tools in oncology, today announced that it has earned ISO 13485:2016 certification from Bureau Veritas. This certification indicates that the company’s quality management systems meet the specific standards required for the design, development, production and marketing of in vitro diagnostic kits, and lays the foundation for a continuous improvement process for in vitro diagnostic kits. It also demonstrates IntegraGen's commitment to a proper industrial approach through the adoption of international quality standards and demonstrates the company’s ability to best meet the needs of its academic and industrial customers.
“Achieving ISO 13485 certification is the result of over one year of continuous efforts and indicates that IntegraGen has taken the necessary steps to be compliant with regulatory requirements that govern the development and manufacturing of clinical diagnostic kits and that we are also committed to continuous quality improvement,” stated Bernard Courtieu, IntegraGen’s President and CEO. “It also demonstrates that our quality system ensures the in vitro diagnostics we develop and distribute, including our miRpredX kit which predicts the response to anti-EGFR treatments for patients with metastatic colorectal cancer, are manufactured in compliance with the highest standards for safety, product performance and reliability.”
IntegraGen is a company specializing in deciphering the human genome and producing relevant and easily interpretable data for academic and private laboratories. IntegraGen’s oncology efforts provide researchers and clinicians with sophisticated tools for analysis and therapeutic individualization of treatment approaches allowing them to tailor therapy to the genetic profiles of patients. As of December 31, 2017, IntegraGen had 38 employees and had generated revenue of €6.2 million in 2017. Based in Evry Genopole, IntegraGen also has an U.S. office in Cambridge, Massachusetts. IntegraGen is listed on Euronext Growth (ISIN: FR0010908723 - Ticker: ALINT - PEA-SME).
For more information, visit www.integragen.com