Miraculins Inc.

Miraculins Inc.

May 17, 2010 09:03 ET

Miraculins Develops Ultrasensitive Assay for Soluble Endoglin

Company's Assay the First Designed for the Detection of sEng in Urine

WINNIPEG, MANITOBA--(Marketwire - May 17, 2010) - Miraculins Inc. (TSX VENTURE:MOM) (the "Company"), a medical diagnostic company focused on developing and commercializing diagnostic tests for unmet clinical needs, 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 – 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 (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.

Highlights of the Miraculins Soluble Endoglin Assay

  • Highly sensitive: Demonstrates sensitivity of <1 pg/mL in serum and detects natural urine samples with 7-24 fold stronger signals than competitor assay while maintaining a 97% recovery of recombinant sEng.
  • Minimal serum volume: Uses 5-10 uL compared to 50 uL in competitor assay
  • High precision: Exhibits a median CV in duplicates from serum samples (n=39) of 1.7% (range 0.1% - 9.3%).

About Miraculins Inc.

Miraculins is a medical diagnostic development company focused on non-invasive tests for unmet clinical needs. Miraculins is bridging the gap between commercially available diagnostic tests and research conducted at leading research institutions around the world. The Company's lead program, a suite of biomarkers for preeclampsia, is partnered with Inverness Medical Innovations (NYSE:IMA), one of the world's largest diagnostic companies.

Caution Regarding Forward-Looking Information

Certain statements contained in this press release constitute forward-looking information within the meaning of applicable Canadian provincial securities legislation (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, our objectives, goals, targets, strategies, intentions, plans, beliefs, estimates and outlook, including, without limitation, our anticipated future operating results, and can, in some cases, be identified by the use of words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.

These statements reflect management's current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: Miraculins' early stage of development, lack of product revenues and history of operating losses, uncertainties related to clinical trials and product development, rapid technological change, uncertainties related to forecasts, competition, potential product liability, additional financing requirements and access to capital, unproven markets, supply of raw materials, income tax matters, management of growth, partnerships for development and commercialization of technology, effects of insurers' willingness to pay for products, system failures, dependence on key personnel, foreign currency risk, risks related to regulatory matters and risks related to intellectual property and other risks detailed from time to time in Miraculins' filings with Canadian securities regulatory authorities, as well as Miraculins' ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this news release. Miraculins cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on Miraculins' forward-looking statements to make decisions with respect to Miraculins investors and others should carefully consider the foregoing factors and other uncertainties and potential events.

These risks and uncertainties should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, Miraculins cannot provide assurance that actual results will be consistent with these forward-looking statements. Miraculins undertakes no obligation to update or revise any forward-looking statement.

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