Test Developed for Uterine Infections Impacting Fertility

Approximately 10% of women in the general population may have chronic endometritis, but among infertile women undergoing IVF, the rate is 15%, with rates estimated as high as 60% among women experiencing recurring implantation failure or miscarriage.

Microbiological culture can identify the pathogen in some cases and lead to tailored antibiotic treatment, but cultures are laborious and time consuming, and some pathogens that are quite typical causes of endometritis do not grow under standard culture conditions, so infections can be missed using this method.

Igenomix (Valencia, Spain), a reproductive genetics firm, have developed the first commercial assay for diagnosing chronic endometritis, a symptomless infection in the uterine lining that can impact a woman's fertility. The firm is commercializing the test, along with other genetic analyses of endometrial status, in the EU and plans to bring it to its USA laboratories upon CLIA approval.

The assay is called Analysis of Infectious Chronic Endometritis, or ALICE, and the Igenomix test uses next-generation sequencing to detect nine different pathogens causing chronic infection: Chlamydia trachomatis, Enterococcus, Escherichia coli, Gardnerella vaginalis, Klebsiella pneumoniae, Mycoplasma hominis, Neisseria gonorrhoeae, Staphylococcus, and Streptococcus. The ALICE test will be commercialized along with two other genetic assays the firm has already been marketing, which assess receptivity of the endometrium and health of the uterine microbiome, respectively.

The Igenomix endometrial microbiome metagenomic analysis, or EMMA, uses 16S RNA sequencing to determine the proportion of Lactobacillus, or healthy bacteria, in the uterus. The firm's scientists recently demonstrated that Lactobacillus-dominated microbiota led to improved implantation rates and pregnancy outcomes in a small preliminary study. The Igenomix endometrial receptivity test, or ERA, measures the expression of 248 genes involved in receptivity to embryo implantation, and is designed to tell physicians a woman's personalized optimal window for an embryo transfer. More than 32,000 patients worldwide have already used the test. A study was published in the June 2018 issue of the American Journal of Obstetrics and Gynecology.

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