IntegraGen and GoPath Laboratories Sign Licensing Agreement for the Commercialization of miR-31-3p Test in North America

Regulatory News:

INTEGRAGEN (Paris:ALINT), a company specializing in the transformation of data from biological samples into genomic information and diagnostic tools for oncology, and GoPath Laboratories, a state-of-the-art CAP-accredited, CLIA-certified molecular diagnostic laboratory providing anatomic pathology, hematopathology, and cancer testing for clinicians, hospital systems, and pharmaceutical firms, announced today the signing of a non-exclusive licensing agreement allowing GoPath to develop and provide a test based on IntegraGen’s proprietary miR-31-3p biomarker to physicians in the United States and Canada. The test will complement GoPath’s specialized molecular diagnostic testing portfolio for cancer and enable clinicians to identify metastatic colorectal cancer patients who have a higher likelihood of response to anti-EGFR therapy.

"Based on published clinical data which demonstrates the ability of miR-31-3p to proactively identify RAS wild-type metastatic colorectal cancer patients who will have increased benefit from treatment with anti-EGFR therapy, we feel the miR-31-3p expression test will complement our existing test offering for this patient population,” stated Jim Lu, M.D., Ph.D., Founder and CEO of GoPath Laboratories.” We look forward to making this test available to clinicians in 2018, once we have completed the validation steps in our laboratory.”

"From a clinical perspective, miR-31-3p represents an additional biomarker oncologists will be able to utilize to properly select a potential treatment approach for metastatic colorectal cancer patients. said Zev Wainberg, M.D., Associate Professor at the UCLA School of Medicine and Co-Director of the UCLA Gastrointestinal Oncology Program. "This is one more step towards realizing the promise of personalized medicine by treating patients with the most appropriate drug according to their molecular profile.”

"This partnership with GoPath is a significant step for IntegraGen Diagnostics since it will enable physicians in the U.S. and Canada to utilize miR-31-3p testing to assist with personalizing their approach to the treatment of patients with metastatic colorectal cancer,” added Bernard Courtieu, IntegraGen’s CEO. "With over five years of research and development efforts and published results from multiple clinical studies, miR-31-3p expression testing represents a major improvement for treating cancer patients.”

About Metastatic Colorectal Cancer

Colorectal cancer is third most common cancer in men and second most common in women with over 1.3 million new cases annually on a worldwide basis. This includes over 345,000 new cases in Europe and 135,000 new cases in the United States on an annual basis.¹ An estimated 25% of patients with colorectal cancer will present with metastatic disease at the time of diagnostic with up to an additional 50% of patients developing mCRC following initial diagnosis.² An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.¹ Approximately 50% of patients with metastatic colorectal cancer, representing 347,000 patients worldwide, have RAS wild-type tumors.³

1. World Health Organization – International Agency for Research on Cancer, 2017

2. Van Cutsem E, Cervantes A, Nordlinger B, Arnold D for the ESMO Guidelines Working Group. Metastatic colorectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014; 25 Suppl 3:iii1-9.

3. Peeters M, et al. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015; 51:1704-13.

About GoPath Laboratories

GoPath Laboratories is a state-of-the-art molecular diagnostics laboratory offering anatomic pathology, hematopathology, and hereditary cancer testing services for clinicians, hospitals, and pharmaceutical firms. The company employs the latest molecular technology platforms including NGS, FISH, and microarray analysis to provide our clients with a better-defined diagnosis, personalized treatment options, risk prediction for cancer recurrence, and stratified immunoresponse in pharmaceutical research. GoPath takes pride in offering unparalleled TATs, exceptional customer service, and 24/7 access to reports.

About IntegraGen

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, 2016, IntegraGen had 38 employees and had generated revenue of €6.0 million in 2016. 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

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