Endomir Logo

A microRNA-based molecular screen for endometriosis.

Intended Use Population

Individuals assigned female at birth who exhibit symptoms suggestive of endometriosis, such as abdominal pain, pelvic pain, and/or infertility.
The results from EndomiR should be used alongside clinical history and other diagnostic tests as part of a comprehensive diagnostic approach.
EndomiR results should not be used as the sole indicator of endometriosis.

Test Information and Methods

EndomiR is a microRNA-based multivariate molecular assay that evaluates expression levels of a proprietary panel of microRNA targets in human peripheral blood, selected for strong association with endometriosis based on rigorous scientific research [1,2]. The algorithm evaluates the presence of each microRNA individually, the quantitative relationship between the miRNA, and generates a patient-specific endometriosis risk score, provided as the EndomiR score. A higher EndomiR score suggests a higher likelihood for endometriosis. Clients will be informed of any updates made to the test methodology and/or reporting process. This test is inspected by the COLA Accreditation Agency under the Chemistry/Endocrinology discipline.

Analysis Algorithm

The algorithm used to generate the EndomiR score was built using a robust iterative process of evaluating independent bioinformatic models of data analysis.
It was developed using samples from individuals who underwent diagnostic laparoscopy to confirm or rule out the presence of endometriosis.
Data from multiple independent studies in which patients provided peripheral blood samples were combined to develop the analysis algorithm [1].
All patients had a history of symptoms that met the clinical test intake (intended use) criteria for endometriosis evaluation and differential diagnosis.

Specimen
Plasma

Requirements:Collect 1.8 ml of plasma in a screw cap cryovial (with external thread and cap, free from DNase/RNase/Endotoxin) after centrifugation of blood collected in a purple top EDTA tube (K2 EDTA vacutainer). Plasma samples should be frozen in a standard minus 20°C freezer. If plasma cannot be immediately separated after the blood draw, allow the blood EDTA tube to come to room temperature and place the tube at 4°C until it can be processed, within 2 hours of collection.

Shipping:Shipping: Plasma specimens should be shipped frozen (on 2-4 ice packs) overnight on a Monday or Tuesday for next morning arrival at Afynia. Consider shipping weekly/biweekly batches of plasma samples to optimize costs. Any specimens sent to Afynia Laboratories must be collected at an appropriately certified facility by a credentialed healthcare professional.

Turnaround Time is generally 7 days upon specimen receipt at Afynia Laboratories.

All testing and analysis is performed on site at Afynia Laboratories.

Afynia does not refer specimens to an external facility for any portion of testing or reporting.

References
  1. Papari E, Noruzinia M, Kashani L, Foster WG. Identification of candidate microRNA markers of endometriosis with the use of next-generation sequencing and quantitative real-time polymerase chain reaction. Fertility and Sterility. 2020 Jun 1;113(6):1232-41.
  2. Ronsini C, Fumiento P, Iavarone I, Greco PF, Cobellis L, De Franciscis P. Liquid biopsy in endometriosis: a systematic review. International Journal of Molecular Sciences. 2023 Mar 24;24(7):6116.