SERENITY, early detection of genetic predisposition to breast and ovarian cancer, widely accessible in Europe by May's end
Geneva, Switzerland - 14 April 2015
ESPERITE launches its oncology genetic tests with SERENITY; the risk-free, convenient, and accurate test that screens the entire coding regions of the BRCA1 and BRCA2 genes, detecting all variants and reporting results in less than 15 days. ESPERITE's local commercial structures will make SERENITY widely accessible throughout Europe at an end-user price of 520 euros. The fully validated SERENITY test has already confirmed its market potential with oncologist, gynecologists and customers in five countries.

Sophia Genetics' bio-informatics platform ensures SERENITY top analytical performance and the highest specificity and sensitivity in the market. SERENITY provides the most comprehensive genetic information to ascertain the risk of breast and ovarian cancer, and address it most effectively. Early detection and precise identification of BRCA1 and BRCA2 variants saves lives. SERENITY empowers clients and doctors to take preventive personalized actions best-suited for the identified mutation, resulting in vastly improved survival rates and better quality of life.

Genoma, proteomics and genetic predictive medicine division of ESPERITE, primes SERENITY with the most advanced features for commercial leadership: CE-IVD and ISO13485 certified processes, fully validated accuracy and reliability, and compliant with the most stringent quality standards, laws and directives in the EU and Switzerland.

SERENITY is performed in Genoma's state-of-the-art lab in Geneva, the largest clinical genetic center in Europe, with Next Generation Sequencing (NGS) technologies. Genoma's world-class experts with extensive experience in BRCA analysis by NGS produce the genetic information that is interpreted by Swiss State-certified expert onco-geneticists.

Breast cancer is the most common cancer among European women with growing incidence rates (499,560 in 2012). The global market for breast cancer diagnostic and drug technologies was about $20.8 billion in 2012 and is expected to reach $27 billion in 2019. Ovarian cancer was diagnosed in 65,538 women in Europe in 2012. There is an increasing demand for genetic testing as product awareness permeates society and larger segments move into predictive and preventive medicine. Strong growth is benchmarked for SERENITY, a high-profit-generating product.

BRCA1 and BRCA2 discoveries have fundamentally changed the management of hereditary breast and ovarian cancer. BRCA1 and BRCA2 are tumor suppressor genes that help to ensure the stability of the cell's genetic material. When either of these genes suffers a mutation, DNA damage may not be repaired properly, and cells are more likely to develop additional genetic alterations resulting in cancer. Certain mutations in BRCA1 and BRCA2 genes predispose to greatly increased risks of up to 80% for breast cancer and up to 50% for ovarian cancer. BRCA mutations account for 5-10% of all breast cancers and 10-15% of all ovarian cancers.

About 50% of women with mutations in BRCA1 or BRCA2 have no family history of breast or ovarian cancer and ignore they carry cancer-causing mutations. A survey revealed that only 19% of US primary care physicians accurately assessed family history for BRCA1 and BRCA2 testing (AmJ PrevMed. 2011;40(1):61-66). Absent population-wide screening, many women with BRCA1 or BRCA2 mutations would not be identified until they developed cancer, because standard diagnostics only detect already present changes in the tissue.

Leading scientists advocate for BRCA1 and BRCA2 genetic screening for every woman at about age 30 as part of routine medical care. SERENITY will facilitate the medical community's ongoing shift towards broader genetic screening policies. Most types of inherited breast and ovarian cancer can be prevented, if early detected: SERENITY makes it possible. Other genetic tests don't screen the entire BRCA1 and BRCA2 genes and/or can only detect certain mutations, or screen other genes which provide information with no preventive value.

Frederic Amar, CEO of ESPERITE group: "SERENITY materializes our commitment to improve health in society by reducing cancer morbidity and mortality. Accessible throughout Europe at an affordable price, SERENITY reflects as well our commercial strategy and competitive advantage. SERENITY is a quality milestone in preventive medicine, and positions Genoma as a reference in the fast-growing oncology genetic screening market."