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Genclis SAS : Confirms Potential of its Severidia(R) Test on 47 TNBC patients

  • 100% of patients classified with Severidia® in the "good outcome" subgroup were alive after 2,500 days
  • Improved p value (p < 10-5)

NANCY, France, Nov. 25, 2014 (GLOBE NEWSWIRE) -- Genclis, a molecular diagnostic company in the fields of allergy and cancer, today presents additional clinical data for its molecular diagnostic test Severidia® in non-metastatic triple-negative breast cancer patients in the context of the 4th Munich Biomarker Conference, to be held in Munich, Germany, on November 25 and 26, 2014.

In October 2014, Genclis presented the first clinical data for Severidia® at the Personalized Diagnostics Today session of the American Association for Clinical Chemistry (« AACC ») conference. These data were 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.

Data presented in Munich include 15 additional TNBC patients and as well as a longer duration of the clinical observation (+ 9 month) for the first 32 patients in the initial replication set. The 15 additional patients came from the same NCI biobank, had same inclusion criteria and had DNA and RNA sequencing under the same protocol.

In the larger population of 47 patients, the probability of survival after 2,500 days for patients classified with a good outcome was unchanged, at 100%, and the p value of the statistical observation improved by a log (p < 10-4 vs. p < 10-5).

Dr. Bernard Bihain, CSO and Chairman of the Board of Genclis said: "These additional clinical data confirm the robustness of the test as a diagnostic tool for severity of triple-negative breast cancer". He added: "They warrant a rapid development of Severidia®. We are currently starting additional studies to confirm the clinical utility of the biomarker".

Stéphane Boissel, CEO of Genclis, said: "In 2015, we should obtain additional data that would give Severidia® a level of evidence compatible with expectations in terms of both registration and reimbursement of the test". He added: "In parallel, we will be conducting clinical validation studies in other indications so as to validate the cross-functional feature of this disruptive, proprietary approach in the growing field of cancer prognostic biomarker".

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

The presentation made in 4th Munich Biomarker Conference will be posted on the Company's website from November 27, 2014.

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 DNA/RNA transcription infidelity by Genclis. This work was patented (granted in the USA and Europe) and published (in PNAS) in 2007. Whereas DNA/RNA transcription is almost a match in normal cells, it has been shown to be divergent in cancer cells. And Genclis has demonstrated that the level of divergence 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® could 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.

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 - presse@atcg-partners.com

PR Genclis result http://hugin.info/164309/R/1873825/660019.pdf

HUG#1873825

Source: Genclis SAS