Miraculins, a medical diagnostic development company focused on non-invasive tests for unmet clinical needs, has updated its preeclampsia program by developing an ultrasensitive assay for the detection of soluble endoglin (sEng).

According to the Miraculins, the test has been optimized for serum and urine in the ELISA format. As a further benefit, Miraculins’ sEng test requires less sample volume than competing tests. sEng is the lead marker from the company’s preeclampsia biomarker portfolio.

Independent researchers have reported the diagnostic utility of soluble endoglin in both serum and urine for preeclampsia. Miraculins ultrasensitive sEng assay utilizes highly sensitive antibodies that have been supplied from Inverness Medical Innovations’ Biosite division, Miraculins collaborative research and development partner. The assay also utilizes a proprietary diluent, developed by Miraculins, to optimize the sensitivity, precision and recovery of natural sEng in both serum and urine.

Miraculins has said that while maintaining equivalent correlation of serum sEng to the competitor’s assay, Miraculins assay was able to detect 10 – 60 pg/mL of sEng in urine while the competitor’s sEng assay was not able to detect sEng in the same samples.

Under the company’s recent partnership with Inverness Medical Innovations (NYSE:IMA), Miraculins retained certain commercial rights to its preeclampsia biomarkers, including endoglin, and received from Inverness a secure supply of reagents and certain rights to intellectual property related to the biomarker endoglin.

Christopher Moreau, president and CEO of Miraculins, said: “Based on the worldwide attention that endoglin is receiving and its potential to be an important marker in the diagnosis of preeclampsia, we believe there will be significant interest in our assay.

“Our initial focus will be to offer this assay to investigators as a research-use-only (RUO) kit to support preeclampsia research, preeclampsia therapy development and clinical trials. However, we will also be looking at the potential of entering the analyte specific reagent (ASR) market in the US using clinical grade sEng antibodies.”