Genclis selected to present its diagnostic technology Severidia(R) at the St. Gallen International Breast Cancer Conference

NANCY, France, Jan. 9, 2015 (GLOBE NEWSWIRE) -- Genclis, a molecular diagnostic company in the fields of allergy and cancer, today announced that its communication on "using next generation sequencing to predict triple-negative breast cancer outcome" has been selected for poster presentation at the upcoming 14th St. Gallen International Breast Cancer Conference, to be held in Vienna, Austria, on March 18-21, 2015.

In 2014, Genclis presented the first clinical data for Severidia®, its molecular diagnostic test developed in non-metastatic triple-negative breast cancer patients. These data were based on a robust retrospective study conducted on a sample of 65 patients from 11 different clinical centers and for which a genomic sequencing was performed through NGS technology. Twenty patients were used in a training set and 45 patients, with a similar profile, were used in blind replication.

Patients from the training set were effectively (> 90 % accuracy) separated according to their good or poor clinical outcome based on either somatic mutation rate (SM), expression profiling (EP) and RNA/DNA divergences rate (the "RDD Model"). However SM and EP model performances dropped dramatically after cross validation while RDD Model retained greater than 90 % accuracy. Accordingly, blinded application of the 3 models to the 45 patients of the replication set yielded non-significant predictive value in Kaplan Meier analysis for the SM and EP models but the RDD Model effectively predicted clinical outcome. The probability of survival at 2,500 days is estimated to be 100% for patients predicted with good outcome and only 24% for those predicted with poor outcome.

Dr. Bernard Bihain, Chairman of the Board and CSO of Genclis, said: "RNA/DNA divergences are previously unsuspected molecular events that are strongly associated with the severity of the diseases. Analysis of the molecular events causing RDD and expending the finding to larger cohort of TNBC patients are the next steps in the development of this novel concept".

Stéphane Boissel, CEO of Genclis, said: "2015 should be a great year for Severidia®, our molecular diagnostic test initially developed in non-metastatic triple-negative breast cancer patients. We are currently working on adding between 200 and 300 patients samples sequencing in two or three different additional retrospectives studies in this indication as well as preparing for the start prospective studies in the US as soon as from 2015".

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/Neu, the 3 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 Severidia®:

Severidia® is the first diagnostic product from the pioneering work on transcription infidelity by Genclis. This work was patented (issued in the USA and Europe) and published (in PNAS) in 2007. Genclis has now demonstrated that the level of divergence between RNA and DNA correlates with clinical outcome of cancer patients.

By measuring precisely the divergence between DNA and RNA (the RNA/DNA Divergence Rate, or "RDD Rate"), Severidia® assess the risk of cancer relapse at a robustness level unseen in solid tumors as it does not prejudge of genes involved in the disease (a poorly documented information in solid tumors) but instead measures a biological phenomenon universally found in any given cancer.

This is why Genclis believes it could make of Severidia® a scientific and technological gold standard of cancer prognostic biomarkers as the only test capable of classifying the "hard-to-classify" cancers.

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.


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

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

ATCG Press: Marielle Bricman, +33 6 26 94 18 53 or Judith Aziza, + - press@atcg-partners.com

PR Conference http://hugin.info/164309/R/1885533/666473.pdf


Source: Genclis SAS