New developments | GynEC-DX

Since 2013, Reig Jofre has been leading new developments around GynEC^®-DX to extend its application range. These activities are essentially focused on biomarker-guided surveillance of asymptomatic women at high risk for endometrial cancer; a market segment with high potential and short-term clinical uptake.

GynEC^®-DX offers a better precision than the diagnostic techniques based on histological classification. It strengthens the decision making confidence of clinicians, especifically in cases of suspicion of endometrial cancer in the peri- and post-menopausia. These suspicious profiles include cases of recurrent bleeding, patients with hyperplasia (simple or complex, with or without atypia), endometrial polyps or irregular endometrial line with no clear histological result, and patients with Lynch syndrome.

To strengthen the use of GynEC^®-DX in populations at higher risk of endometrial cancer, phase IV clinical trials have been initiated in collaboration with reference centers:

Asymptomatic Endometrial Polyps
This clinical trial tests the ability of GynEC^®-DX to identify neoplastic lesions in patients with asymptomatic endometrial polyps. Its objective in the medium term is to modify the therapeutic attitude avoiding unnecessary surgeries. Centers involved: Araba-Santiago (Álava), Bellvitge (Barcelona) and La Candelaria (Tenerife) (university hospitals , the hospital complex of Ourense (Orense), La Zarzuela (Madrid), Requena (Requena), Álvarez Buylla and San Carlos (Madrid) hospitals and the Jiménez Díaz Foundation (Madrid).

Síndrome de Lynch
This clinical study, initiated in 2015 and led by the La Paz hospital (Madrid), aims to validate the use of GynEC^®-DX in the biomarkers-guided surveillance of patients with Lynch syndrome. Preliminary results have been presented at 33^rd National Congress of the Gynecologic Oncology Section of the Spanish Society of Gynecology and Obstetrics (SEGO) hold in November 2016 in San Sebastián.

In parallel, the diagnostic efficiency of GynEC^®-DX is being demonstrated in comparison with conventional techniques based on histological classification:

Inconclusive or insufficient samples in Anatomy-Pathology
Current diagnostic methods such as anatomopathological analysis on endometrial aspirate or hysteroscopy guided biopsy are not 100% sensitive nor free of potential complications for patients. Furthermore, the rate of insufficient samples for endometrial aspirate reaches 30% and the overall rate of failure to obtain a diagnosis can exceed 40%. A recent multicenter study led by the Jiménez Díaz Fundation (Madrid) has evaluated the use of GynEC^®-DX molecular test in the diagnosis of endometrial cancer on samples of endometrial aspirates in which the pathologist could not obtain a diagnosis through histological analysis (Sanz, 2016). The study concluded that GynEC^®-DX yields a conclusive result in 88.9% of the samples. In addition to the fact that the amount of specimen required is less than that required for histological diagnosis, the high negative predictive value of GynEC^®-DX allows the avoidance of invasive diagnostic methods in a large number of patients and represents a saving for the public health system.
Referencia: Sanz Baro, R. (2016) “Estudio en fase IV del test de diagnóstico molecular de cáncer de endometrio GynEC^®-DX sobre muestras insuficientes o no concluyentes”. PhD thesis, Autonomous University of Madrid.