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21.07.2014 18:18:00

Genomic Vision Reaches Significant Milestones within the Framework of Its Collaboration with Quest Diagnostics, Triggering a Payment of €1.7M

Regulatory News:

Genomic Vision (Paris:GV) (FR0011799907 – GV / PEA-PME eligible), a molecular diagnosis company that specializes in the development of diagnostic tests for genetic diseases and cancers using the DNA molecular combing process, today announces that, during the first half of 2014, it has reached a number of significant technical and scientific milestones, as foreseen within the framework of its strategic partnership with American company Quest Diagnostics.

Validation of a diagnostic test for Lynch Syndrome
The test developed by Genomic Vision makes it possible to directly visualize all of the five major genes involved in hereditary nonpolyposis colorectal cancer (HNPCC, or Lynch Syndrome): MSH2 and its upstream gene EPCAM and the MLH1, MSH6 and PMS2 genes. It helps provide unambiguous information on structural variations in these regions. The test’s initial validation was achieved in collaboration with Dr Juul Wijnen’s team from the Human and Clinical Genetics department at LUMC (Leiden University Medical Center), in the Netherlands. The marketing of this test by Quest Diagnostics in the United States is due to be launched in 2015.

Validation of a new protocol for the Genomic Morse Codes for the diagnostic tests for breast and ovarian cancer (BRCA) and Lynch Syndrome
This milestone consists in the approval of a new protocol for detecting probes making up Genomic Morse Codes specific to the BRCA and HNPCC tests that is compatible with the new scanner. This fast and easy protocol is made possible by the new scanner’s performances, notably in terms of sensitivity and speed with a view to using high-volume tests. The optimization and automation of the DNA extraction protocol are continuing.

Launch of the production of the high-throughput scanner’s pilot instruments
Designed by Genomic Vision in partnership with ITL, a British company specializing in the development of laboratory instruments, this scanner is specifically devoted to molecular combing. The production of the pilot instruments follows the validation of two prototypes at the end of 2013. Quest Diagnostics is due to be equipped with the scanner’s pilot instruments in early 2015.

Reaching these milestones has resulted in Quest Diagnostics paying Genomic Vision €1.7 million in milestone payments.

Aaron Bensimon, Genomic Vision’s co-founder and Chairman, says: "I would like to thank all of our teams, as well as our external partners’ teams, who have contributed to us achieving these milestones defined within the framework of our partnership with Quest Diagnostics. Thanks to their high-quality work, we are in line with the schedule presented at the time of our IPO, which aims to equip Quest Diagnostics with our new high-throughput scanner by 2015 in order for it to be able to market the HNPCC and BRCA tests in the United States through its vast network of laboratories during the same year.

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ABOUT GENOMIC VISION
A spinoff of the Institut Pasteur, Genomic Vision is a molecular diagnostics company specialized in developing diagnostic tests for genetic diseases and cancers. Using "molecular combing”, an innovative technology that allows the direct visualization of individual DNA molecules, Genomic Vision detects quantitative and qualitative variations in the genome that are at the origin of numerous serious pathologies. Having benefited from the financial support of the Institut Pasteur, SGAM AI, Vesalius Biocapital and Quest Diagnostics, the Company is developing a solid portfolio of tests that notably target breast cancer and cancer of the colon. Since 2013, the Company has marketed the CombHeliX FSHD test for identifying a myopathy that is difficult to detect, Facio-scapulo-humeral dystrophy (FSHD), in the United States thanks to a strategic alliance with Quest Diagnostics, the American leader in diagnostic laboratory tests, and in France.

ABOUT MOLECULAR COMBING
DNA molecular combing technology considerably improves the structural and functional analysis of DNA molecules. DNA fibers are stretched out on glass slides, as if "combed”, and uniformly aligned over the whole surface. It is then possible to identify genetic anomalies by locating genes or specific sequences in a patient’s genome using genetic markers, an approach developed by Genomic Vision and patented under the name Genomic Morse Code. This exploration of the entire genome at high resolution via a simple analysis enables the direct visualization of genetic anomalies that are undetectable by other technologies.

For further information, please go to www.genomicvision.com

DISCLAIMER

This press release contains certain forward-looking statements concerning Genomic Vision and its business. Such forward-looking statements are based on assumptions that Genomic Vision considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the prospectus on which the French Financial Market Authority (AMF) granted its visa n° 14-087 on March 19, 2014 and to the development of economic conditions, financial markets and the markets in which Genomic Vision operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Genomic Vision or not currently considered material by Genomic Vision. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Genomic Vision to be materially different from such forward-looking statements.

This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Genomic Vision shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

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