DotLab announced the results from a new study showing that its endometriosis test, which aids in diagnosing the disease, has the potential to also be used to monitor disease progression and response to therapy. Previous studies comparing the results of the test to laparoscopic surgery, the gold standard for diagnosis, demonstrated the test's high accuracy in detecting endometriosis.

The study was  published  in  Reproductive Sciences and was led by Dr.  Hugh Taylor, Chair of the Department of Obstetrics, Gynecology, and Reproductive Sciences at  Yale School of Medicine  and a leading scientist, physician, and academic. Dr Taylor is also the Chief Medical Officer of DotLab.

To analyze the potential of the biomarkers to monitor disease progression and treatment response, laparoscopies are required at more than one time point. Therefore, in the study, endometriosis was induced in non-human primates - a robust model for studying the disease - and half of the animals were administered simvastatin, an alternative approach for treating endometriosis, for 90 days. Endometriosis was evaluated after three months in both the treated and untreated groups via laparoscopy. The levels of specific microRNA biomarkers used in the DotLab endometriosis test were analyzed prior to laparoscopy. The results revealed:

•  The extent of disease was significantly lower after three months in the treated group compared to the untreated group. Total disease volume decreased by approximately 65%.

• The microRNAs analyzed reverted to normal levels in the treated group compared to the untreated group, with either a 90-93% decrease or 7.5-fold increase (p<0.05), consistent with the expression patterns previously seen in humans.

From the study, “This is the first report showing serum miRNA expression normalized in response to endometriosis (EMS) treatment, supporting the potential for this class of biomarkers to be used both to diagnose EMS and to monitor its progression and response to therapy.”

One previous study found that, “MicroRNAs 125b and 150 are significantly elevated in patients with endometriosis compared to controls, and can potentially be used as serum diagnostic markers for the disease. Importantly, these are the first serum biomarkers that are able to pre-operatively distinguish the presence of endometriosis among patients in whom it was suspected.”

DotLab's first product, DotEndo, is a non-invasive saliva test for endometriosis, a chronic condition that affects one in ten women worldwide.