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Clinical validation

Development

GynEC®-DX biomarkers were identified by gene expression screening comparing 52 endometrial carcinomas and 10 normal endometria.

To develop a minimally invasive screening test, biomarkers were tested on endometrial aspirates. The results demonstrated that uterine fluids are representative of the molecular alterations characterizing the primary tumours.

GynEC®-DX biomarkers showed high sensitivity and specificity for uterine aspirates corresponding to initial stages of endometrial carcinomas. Results were published in International Journal of  Cancer (2011) 129: 2435-2444.

Clinical validation

El uso de ha sido validado en un estudio clínico multicéntrico con doble ciego en el que han participado 14 hospitales españoles.

The use of GynEC®-DX was validated in a double blind, prospective, multicenter study involving 14 Spanish hospitals.

Population: 514 pre- o post-menopausic patients wpresenting abnormal uterine bleeding were recruited. In this particular age stratum, the vast majority of women do not have endometrial cancer and it is essential to rule out cancer as soon as possible with a minimal discomfort to the patients.

Study control: An external clinical organization (CRO) carried out quality control and monitored the study, and an external statistician independently analyzed the data on the performance of the molecular classifiers.

Results: The study demonstrated that the combination of GynEC®-DX with histological analysis has a sensitivity (91%) equal to the hysteroscopy and excellent specificity (97%).

GynEC®-DX has a positive predictive value of 75% & a negative predictive value of 99% allowing excluding endometrial cancer early.

The molecular test allowed the identification of six cases of endometrial cancer that were erroneously classified as negative or inconclusive by histology in uterine aspirate samples, one case was not detected by hysteroscopy and another was detected only after surgery.

Somes cases classified as positive by GynEC®-DX have not been confirmed by the pathologist. These may be pre-neoplastic lesions that need longer follow-up.

In addition to its international coverage through the International Journal of Cancer, GynEC®-DX is mentioned in the protocols for the diagnosis and screening of endometrial cancer of the Spanish Society of Gynaecology and Obstetrics (SEGO).