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Genclis SAS Releases First Data for Severidia(r) Molecular Diagnostic in Triple-Negative Breast Cancer

NANCY, France, Oct. 29, 2014 (GLOBE NEWSWIRE) -- Genclis, a molecular diagnostic company in the fields of allergy and cancer, announced today the presentation of the first clinical data for its molecular diagnostic test Severidia® in non-metastatic triple-negative breast cancer patients in the context of the Personalized Diagnostics Today virtual conference organized by the American Association for Clinical Chemistry (AACC).

The poster is available on the Company's website (www.genclis.com).

These data are based on a robust retrospective study conducted on a sample of 52 patients from 10 different clinical centers and for which a genomic sequencing was performed through NGS technology. Twenty patients were used in a training set and 32 patients, with a similar profile, were used in blind replication. Data showed that Genclis' proprietary algorithms were able to predict individual patient cancer severity with greater than 90 % accuracy: i.e. 100% of patients classified in the "good outcome" subgroup (2/3 of patients in the replication set) were alive after 2,500 days.

"Triple-negative breast cancer is the most severe form of breast cancer, for which current treatment options are radiotherapy and conventional chemotherapy. Clinicians know that a majority of patients do not truly benefit from this standard of care. At this stage, there are no methods to identify patient with the less severe forms of TNBC, hence it is expected that many patients received treatment with serious side effects that may not be truly useful." said Stéphane Boissel, CEO of Genclis. He added: "This first presentation of data for Severidia® is a very important step for Genclis. The market for tumor prognostic biomarker is set for a rapid growth and, once these NGS data will have been validated in larger clinical trials, Genclis could position its solutions as a new prognostic standard for clinicians".

"It is a very good day for Genclis since, 7 years after discovering and patenting the DNA/RNA transcription infidelity principle, we are able to present the first example of the clinical utility of the concept." said Dr. Bernard Bihain, CSO and Chairman of the Board of Genclis. He added: "Today, we are developing Severidia® test in triple-negative breast cancer as well as in a type of lung cancer. The first data warrants conducting additional clinical studies in these indications as well as the development of Severidia® in other cancers with the objective of reaching the highest level of evidence in each indication that we address".

An oral presentation of the TNBC results will take place at the 4th Munich Biomarker Conference, November 25-26, 2014, Munich, Germany.

About triple-negative breast cancer ("TNBC"):

Breast cancer has a global incidence of 1.677.000 new cases per year, including 794.000 new cases in developed countries (source: Globocan), of which 233.000 new cases in the USA and 367.000 new cases in the European Union. Breast cancer is qualified as "triple-negative" when estrogen, progesterone and HER2, the main targets of modern breast cancer therapeutic agents, are not overexpressed in these cells.

This type of cancer account for 15 to 25% of all breast cancers (source: Medscape), or between 120.000 and 200.000 new cases per year in developed countries. It is considered as the most deadly breast cancer form, with more than 25% of deaths within 5 years of diagnostic. Chemotherapy is used in around 50% of TNBC cancer cases. TNBC tumors respond to chemotherapy. However, they are genetically unstable and thus resistance to chemotherapy treatment are developed in the first five years after chemotherapy. It is known that around 2/3 of TNBC are non-severe TNBC. However, without any proper tool to segment patients based on the severity of their cancer, most patients undergo chemotherapy. It is commonly known that costs of care for TNBC are 80% above average breast cancer costs.

About Genclis:

Genclis is a molecular diagnostic company in the fields of allergy and cancer. Started in 2004, the Company initiated the commercialization of its allergy molecular diagnostic tests in 2014.

In the field of cancer diagnostic, Genclis based its development on the concept of DNA/RNA divergences due to transcription infidelity, an original, proprietary disruptive science. This science has already led to encouraging results in the severity prognostic of triple negative breast cancer ("TNBC"), a severe form of breast cancer. Genclis intends to rapidly impose its solution, Severidia©, as a standard for oncologists to offer their patients alternative treatment and monitoring options.

Based in Nancy and Paris, Genclis had 40 employees as of October 1, 2014. Please visit: www.genclis.com

Contacts:

Stéphane Boissel, CEO: +33.6.74.78.09.25 - sboissel@genclis.com

Bernard Bihain, Chairman and CSO: +33.6.33.02.90.88 - bbihain@genclis.com

ATCG Press: Judith Aziza, +33.6.70.07.77.51 / Marielle Bricman, +33.6.26.94.18.53 - presse@atcg-partners.com

Severidia first Data http://hugin.info/164309/R/1866794/655810.pdf

HUG#1866794

Source: Genclis SAS