Test Developed for Uterine Infections Impacting 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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