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Igenomix laboratory: the first accredited for the endometrial receptivity test

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30 June 2021 Industries

ENAC has granted Igenomix the first accreditation according to the UNE-EN ISO 15189 standard for the performance of an endometrial receptivity test (ERA), intended for patients of assisted reproduction treatments. Specifically, in the accredited test, the expression of more than 200 genes is analyzed by massive sequencing (transcriptomic profile).

This test determines when an endometrium is receptive, that is, when it is ready for the embryo to be implanted, which occurs on certain days of the menstrual cycle. Thereby, gynecologists can determine the optimal day for embryo transfer. It is a very useful test in patients who have recurrent implantation failures with good morphological quality embryos.

In addition to the ERA test accreditation, the Igenomix laboratory includes in its accreditation scope several tests related to the reproduction field for detecting chromosomal alterations, such as preimplantation genetic diagnostic tests, non-invasive prenatal diagnosis, preconception screening in sperm and studies of abortive tissues.

With ENAC's accreditation according to the UNE-EN ISO 15189 standard, the laboratory has demonstrated its technical competence to perform these analyses, a key aspect for ensuring that medical decisions are made based on reliable results, minimal risks to patient safety and improved diagnostic quality.

The standard comprehensively addresses the control of all key processes, that is, pre-analytical, analytical and post-analytical, from the time the request is made until the report is issued, and establishes technical and management requirements, including resources, personnel, facilities and equipment, information systems, quality assurance and reporting procedures.


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