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The first in vitro molecular diagnostic test that can help diagnose early-stage endometrial cancer

Pressmeddelande   •   Jun 02, 2014 09:36 CEST

Bioglan AB (part of Reig Jofré Group) announces the Nordic launch of GynEC®-DX, the first in vitro molecular diagnostic test that can help diagnose early-stage endometrial cancer. 

GynEC®-DX is the first in vitro diagnostic test based on molecular analysis of uterine aspirate samples. GynEC®-DX identifies the absence of Type I and Type II cancer, and pre-neoplastic lesions in complex hyperplasia with atypia.

Endometrial cancer is the 5th most common cancer worldwide, comprising about 4% of all cancers in women. It is the most prevalent gynecological cancer, occurring predominantly after menopause. Common risk factors include hormone factors (therapy, estrogens, contraceptives), obesity, age and family history.

The current routine in the Nordic countries is to take an endometrial biopsy, send it for processing, and then it is visually assessed by a pathologist (pathological-anatomical diagnosis). It can take up to 4 weeks for these results. GynEC®-DX allows for precise diagnosis with molecular biology, allowing for an accurate and reliable result that is not based on subjective visual diagnosis. The results are available within 2-4 days. Furthermore, when taking an endometrial biopsy for visual assessment it is necessary to take a biopsy from the lesion in the endometrium to be able to detect/visualize cancer. This lesion can be missed if the biopsy is taken without visual aid (hysteroscopy). With GynEC®-DX, the uterine aspirate sample is representative of the entire endometrium as molecular biology allows for the detection of minute quantities of RNA. With the implementation of Pipelle and other methods for taking biopsies, general anesthesia is no longer required; however, this has resulted in specimens with insufficient tissue, resulting in problems in assessment and interpretation. Because molecular biology is used, the sample required for GynEC®-DX is much less than the sample required for pathological-anatomical diagnosis.

"There is a worldwide shortage of pathologists, leading to longer waiting times for cancer diagnosis. This is also the case in the Nordic countries," explains Jacqueline Kartberg, Nordic Market Product Manager. "GynEC®-DX is a powerful molecular tool that has important health economics aspects. It offers a negative predictive value of 97% with results within days, reducing patient discomfort and anxiety associated with uncertainty in lengthy diagnostic processes. When GynEC®-DX is combined with pathological-anatomical diagnosis the negative predictive value is 99%.”

In 2011, there were 189 full-time pathologists in Sweden while the need was estimated to be 291 full-time pathologists. With retiring pathologists and little recruitment, the role of GynEC®-DX would be to identify those patients who do not have endometrial cancer. Exclusion of these patients would alleviate the pathologists’ workload.

Jacqueline Kartberg continues, “The innovative GynEC®-DX can detect the absence of early stage cancer since molecular changes precede morphological changes. An early diagnosis can lead to a higher survival rate.”

Bioglan AB (part of Reig Jofré Group) will launch GynEC®-DX at the Nordic Federation of Societies of Obstetrics and Gynecologists (NFOG) meeting in Stockholm in early June.

About GynEC-DX
GynEC®-DX is an in vitro diagnostic test that quantifies the expression levels of a group of genes in samples of endometrial aspirate, translating them into a value indicating the absence of endometrial cancer. GynEC®-DX is indicated for use in pre-or post-menopausal women with abnormal uterine bleeding (AUB). It is a minimally invasive method which can be used in conjunction with other diagnosis techniques for confirming the absence or presence of endometrial cancer. GynEC®-DX identifies the absence of Type I and Type II cancer, and pre-neoplastic lesions in complex hyperplasia with atypia.

GynEC®-DX requires very little patient sample. The endometrial sample is introduced into a vial with preservation solution and is sent by express courier to the analysis laboratory. The sample is subjected to qRT-PCR and the data are analyzed. The results are available within 2-4 days.

Clinical trials have shown that GynEC®-DX has a negative predictive value of 97% (and 99% in combination with pathological-anatomical diagnosis), with a sensitivity of 81% and specificity of 96%.

For more information, visit http://www.gynecdx.se

Click here to read this information in Swedish.

References

1. Colas E, Perez C, Cabrera S, Pedrola N, Monge M, Castellvi J, Eyzaguirre F, Gregorio J, Ruiz A, Llaurado M, Rigau M, Garcia M, Ertekin T, Montes M, Lopez-Lopez R, Carreras R, Xercavins J, Ortega A, Maes T, Rosell E, Doll A, Abal M, Reventos J, Gil-Moreno A. Molecular markers of endometrial carcinoma detected in uterine aspirates. Int J Cancer. 2011 Nov 15;129(10):2435-44.

2. Rosell E, Pérez C, Ortega A, Nieto C, Doll A, Gil A, Ponce J, Abal M, Reventós J, Maes T. Development of a gene expression-based test for the detection of endometrial cancer in uterine aspirates. J Clin Oncol 28:15s, 2010 (suppl; abstr 5066).

3. Ponce J, Gil-Moreno A, Sanchez del Rió A, Garcia E, Fernández de Castillo L, Muruzabal JC, Alvarez E, Fiol G, González C, Torrejón R, Moral JE, Carreras R, Jiménez López J, Repollés M, Ortega A, Rosell E, Nieto C, Maes T, Pérez C, Abal M, Colas E, Reventós J. GynEC-DX, a new test to determine endometrial cancer from endometrial aspirates in patients with abnormal uterine hemorrhage. International Journal of Gynecological Cancer, Volume 21, Supplement 3, ESGO A-373, October 2011.

4. Perez-Sanchez C, Colas E, Cabrera S, Falcon O, Sanchez-del-Río A, Garciá E, Fernández-de-Castillo L, Muruzabal JC, Alvarez E, Fiol G, González C, Torrejón R, Moral E, Campos M, Repollés M, Carreras R, Jiménez-López J, Xercavins J, Aibar E, Perdones-Montero A, Lalanne E, Palicio M, Maes T, Rosell-Vives E, Nieto C, Ortega A, Pedrola N, Llauradó MRigau MDoll AAbal MPonce JGil-Moreno AReventós J. Molecular diagnosis of endometrial cancer from uterine aspirates. Int J Cancer. 2013 Nov 15;133(10):2383-91.

5. Assessment report of the diagnostic test for GynEC-DX detection of endometrial carcinoma in women with abnormal uterine bleeding. Fundació Barcelona Clinic.

Bioglan AB is a contract development and manufacturing organisation with more than twenty-five years of experience in research, development, manufacturing and marketing of pharmaceuticals. Bioglan provide support for pharmaceutical, healthcare and life science companies in all aspects of development and manufacturing of semi-solid and liquid products.

Bioglan is part of Reig Jofré Group, Spain.

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