Miraculins Inc is pleased to update the market on its preeclampsia program by announcing the development of an ultrasensitive assay for the detection of soluble endoglin (sEng).

The test has been optimized for serum and urine in the widely utilized ELISA format. As a further benefit, Miraculins’ sEng test requires significantly 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 (Kusanovich et al, J Matern Fetal Neonatal Med, 2009:11;1021) and urine (Buhimschi et al BJOG, 2010;117: 321) 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.

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

"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", said Company president and CEO, Christopher J. Moreau.

"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 United States using clinical grade sEng antibodies", Moreau added.

"One of the exciting features of this ultrasensitive assay is its ability to detect extremely low levels of endoglin in urine. This format could unlock new opportunities for creating a non-invasive test for preeclampsia by testing urine samples that are already routinely provided by women during their regular doctor’s visits throughout pregnancy", stated Dr. Stephen Frost, Director of Research & Development for Miraculins.

Under the Company’s recently announced partnership with Inverness Medical Innovations, 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.

Source: Miraculins