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news.Miraculins, a medical diagnostic company, has signed a letter of intent with Mount Sinai Services which would allow MSS to acquire FDA regulated commercial products known as analyte specific reagents in order to develop in house clinical tests for Miraculins's growing pipeline of biomarkers.
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Under the agreement, Miraculins will also retain Mount Sinai Services (MSS) to provide laboratory and testing services for future clinical trials and regulatory clearance or approval studies involving other products that Miraculins may seek to develop.
The company has also secured a term sheet with Mount Sinai Hospital that will see it acquire a portfolio of biomarkers for use in developing diagnostic assays for the early detection of preeclampsia, a disease of growing incidence and the leading cause of maternal and prenatal deaths worldwide. Miraculins is also developing an analyte specific reagents (ASR) strategy for these preeclampsia markers.
Furthermore, Miraculins is in various stages of licensing discussions with a number of institutions in regards to a number of additional promising markers.
Christopher Moreau, president and CEO of Miraculins, said: “We are very pleased to have MSS agree to be the first CLIA laboratory to work with Miraculins on its ASR strategy.
“In addition, as Miraculins acquires full regulatory approval for any tests we independently develop, MSS will be a natural part of our distribution plan. Access to the end-user market is critical to both our new business strategy and the longer term adoption of our tests.”