Endometriosis is a chronic and disabling gynecological disease affecting 10% of women of reproductive age, representing 176 million patients worldwide. It is defined as the presence of endometrial-like tissue outside the uterus, capable of invading several organs. It is associated with acute symptoms, mainly consisting of severe pelvic pain and infertility, imposing an annual economic burden estimated at $77,46 billion in 9 European countries and $78.05 billion in the USA.
The current gold standard for diagnosis of endometriosis is an invasive surgical procedure performed under general anesthesia (laparoscopy). It enables the visualization of the lesions by the surgeon and their histological confirmation, usually with an average of 9 years of delay after disease onset. Once diagnosed, endometriosis management frequently combines surgery and non-specific hormonal therapies with limited efficacy. Since these treatments only address the symptoms and not the root causes, disease recurrence is frequent and occurs in up to 50% of the patients.
In close collaboration with international endometriosis experts, Endodiag has developed EndoSearch®, a unique noninvasive, rapid and cost effective diagnostic test. EndoSearch® differentiate patients versus controls and diagnose endometriosis with certainty based on the endometrium biomarkers, without surgery, helping the physician to take decisions on the most suitable patient management.
ENDODIAG (www.endodiag.com) is a biotechnology company developing biomarker-based endometriosis diagnostic products and services. We develop solutions to enable noninvasive and earlier diagnosis of endometriosis, guide treatment decisions, reduce surgical patient morbidity and mortality, prevent chronic effect of disease including pain and infertility, and monitor patient treatment and management.
With this research programme, Endodiag is addressing a major healthcare need, clearly identified as such by the European Community in its statement of June 2005 at the European parliament. EndoSearch® successful validation and deployment will improve the quality of life of millions of patients while significantly reducing endometriosis-associated healthcare costs.
Objectives:
The objectives of this specific project are aligned with the core mission and objectives of the company. We have defined a comprehensive 4-year plan within this project that includes 3 major parts.
Clinical objectives: Analytical and clinical validation of EndoSearch® based on international and prospective clinical studies conducted in 15 investigator sites. The weighing factors of the diagnostic signature for each EndoSearch® biomarker will be fine-tuned and a patent on EndoSearch® biomarker will be filled.
Technical objectives: IVD kit development, validation, and production, including insourcing and analytical validation of selected diagnostic antibodies and reagents, clinical utility demonstration, industrialization and production of the kit.
Regulatory/commercial and dissemination objectives: Ensure compliance of the company activities to ISO:13485 standard, lead an healtheconomics study, achieve CE-marking and FDA approval of the IVD kit. We also plan to expand our route-to-market strategy where we have identified key target markets and communicate with key regulatory and reimbursement authorities within each target market. Finally, we will disseminate our data to the scientific and medical communities through conferences, scientific publications with key opinion leaders, white papers and marketing leaflets, and a dedicated webpage.
