Igenomix has launched a molecular diagnostic that according to the company is the first designed to detect chronic endometritis in women with infertility.
The company’s Analysis of Infectious Chronic Endometritis (ALICE) diagnostic is designed to detect the nine pathogens responsible for chronic endometritis, including Enterobacteriaceae, Enterococcus, Streptococcus, Staphylococcus, Mycoplasma and Ureaplasma.
According to a study published online in February by researchers that included investigators from Igenomix, ALICE was comparable to the combination of traditional hysteroscopy, histology and microbiology, enabling a more accessible, rapid and cost-effective diagnosis for chronic endometriosis. The study was conducted in 65 patients who were assessed for chronic endometritis using all three methods.
“The molecular microbiology method describe herein is a fast and inexpensive diagnostic tool that allows for the identification of culturable and nonculturable endometrial pathogens associated with chronic endometritis,” the researchers concluded in the American Journal of Obstetrics & Gynecology.
The researchers added that their results were similar to all 3 classic diagnostic methods together with a degree of concordance of 76.92%.
“Our aim was to develop a molecular diagnostic tool, comparable, in terms of sensitivity and accuracy, to using the three classical methods combined, overcoming any of their individual or collective shortcomings,” Inmaculada Moreno, Ph.D., researcher at Igenomix and the study’s first author, said in a statement.
ALICE is designed to investigate pathogens causing chronic endometritis, within the endometrial microbiome whose overall health can be studied through Igenomix’s Endometrial Microbiome Metagenomic Analysis (EMMA) test.
EMMA is designed to report the 10 most abundant bacteria in the endometrium, to help improve clinical management of infertile patients by determining the percentage of Lactobacilli and dysbiotic bacteria. EMMA is also intended to indicate the possible presence of bacterial pathogens, that can cause chronic endometritis or other diseases.
According to Igenomix, EMMA can determine the percentage of lactobacillus present in the endometrium, to improve the patient's reproductive prognosis. Healthy women have been found to have either of two types of microbial profiles: “Dominated by Lactobacillus (DL)” and “Not Dominated by Lactobacillus (NDL)”. The latter has a lower implantation rate and a higher miscarriage rate.