What is GynEC®-DX?
GynEC®-DX is an early detection test primarly aimed at gynecologists and/or pathologists who want to rule out endometrial cancer in at-risk patients. It is a non-invasive test performed on endometrial fluid collected through an aspiration cannula during a routine gynecological examination.
GynEC®-DX is an in vitro medical device based on the quantification of the expression of five biomarkers in relation to a reference gene. From these data, the GynEC®-DX decision algorithm generates a value indicative of the presence or absence of cancer.
How did we develop GynEC®-DX?
GynEC®-DX biomarkers were identified by gene expression screening comparing 52 endometrial carcinomas and 10 normal endometria.
To develop a non-invasive test the biomarkers were tested on endometrial aspirate samples. The results showed that uterine fluids were representative of the molecular alterations that characterize primary tumors.
GynEC®-DX biomarkers showed high sensibility and specificity for uterine fluids that correspond to the initial stages of development of endometrial carcinomas.
Results were published in International Journal of Cancer (2011) 129: 2435-2444.
How did we validate GynEC®-DX?
The product was validated in a double blind, prospective, multicenter study involving 14 Spanish hospitals.
514 pre- post-menopausic patients resenting abnormal uterine bleeding were recruited. An external clinical organization (CRO) carried out quality control and monitored the study. An external statistician analyzed the data.
Results were published in International Journal of Cancer (2013) 133: 2383-2391.
How do we commercialize GynEC®-DX?
GynEC®-DX is commercialized in Spain using a business model based on a central laboratory. The sample collection kits are distributed by Reig Jofre and its clinical laboratory performs the analysis.
The aspirate is collected with a Cornier pipelle in the same way as it is done for an anatomopathological analysis and is introduced into a tube containing a preservative. The kit contains the instructions for use, the application form and an envelope for transporting the sample. Results are sent to the doctor by email within 5 business days from the date of reception of the sample.