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A unique noninvasive diagnostic test based on endometrium tissue analysis, which assesses the presence or absence of endometriosis without surgery, helping the physician to make his diagnosis rapidly

Periodic Reporting for period 3 - EndoSearch (A unique noninvasive diagnostic test based on endometrium tissue analysis, which assesses the presence or absence of endometriosis without surgery, helping the physician to make his diagnosis rapidly)

Reporting period: 2019-09-01 to 2020-10-31

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.
During this third year of the project, all clinical, technical and regulatory parts have been continued and work carried out as forecasted for most of the tasks when we were not on lockdown due to the Coronavirus pandemy. An amendment to extend the project of one year was approved mid 2020.
The first clinical study was finished in July 2019, with the recruitment of more than 600 endometriosis patients and 200 controls throughout 20 centers worldwide. During the third year, 4 new KOL/Centers have joined our project, 3 others are in advanced discussions
For technical objectives, we have dedicated this year to the samples and biomarkers analysis, and the analytical validation. Next step will be to analyse all the samples collected and launch a final statistical analysis to validate the biomarkers and launch the next industrialization phase.
For the regulatory part, Endodiag moves towards an ISO 13485 certification process for its Quality Management System according to the progress of EndoSearch's research activities. in the same time, we are also continuing discussions with IVD companies and Large Central Labs in order to evaluate potential collaboration about promotion and sales organisation for our IVD kit, preparing the future marketing strategy of our IVD kit. To do so we benefit from the help of our H2020 coach and from the support consultants expert in strategy and market access in particular health economics experts who are supporting us in order to set up our reimbursement strategy in Europe.
Finally, we also communicated and disseminated our work and progress, mainly with clinical investigators but we also presented an oral communication at AAGL (American Association of Gynecology Laparoscopy) in November 2019 in Vancouver. Unfortunately, due to COVID all our 2020 Congresses have been cancelled and no more communication has been possible. Cecile Real was again finalist of the Women Innovator Prize 2020 with Special Mention Prize from the jury and Endodiag has been nominated amongs the 3 finalists at the prestigious Prix Galien Medstartup 2020.
EndoSearch® is a new diagnostic test, non invasive, cost effective and reliable with a high specificity and sensibility. This panel of biomarkers promises earlier diagnosis and prevention of disease progression using a noninvasive sampling method.

EndoSearch® will thus help physicians in their daily practice, to confirm a suspicion of endometriosis very quickly and easily. EndoSearch® only requires a biopsy of endometrium which can be done during an in office sampling procedure. The sample is then sent to a clinical laboratory like for pap smear and processed according to the EndoSearch® kit instructions. Based on the detection of specific endometriosis biomarker found in the endometrium of patient with endometriosis, EndoSearch® can confirm in a few days the diagnostic of endometriosis.

EndoSearch® enables an early diagnostic of endometriosis with certainty and make a real difference for the physician who can effectively manage patient-care accordingly to the test result. With EndoSearch® diagnostic test, all symptomatic women who have pelvic pain and/or subfertility could be screen for endometriosis and according to EndoSearch® results efficiently treated, preventing endometriosis progression and damages to other organs but also increasing IVF success rates. EndoSearch® impact on patients will be substantial and will benefit to millions of women.

Finally, we are convinced that EndoSearch® will contribute to significantly reduce the endometriosis-associated costs by reducing the number of prescriptions of unsuitable treatments and by limiting the number of surgeries. Screening costs would only represent 2,3% and 3,8% of the economic burden of endometriosis in the US and Europe respectively.
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