About the M.A.MA-Test
What it is
The M.A.MA Test is a non-invasive prenatal diagnostic test able to investigate the development of the fetus and to early identify the congenital developmental fetal defects. It is based on an analysis of a single drop of blood and so it is safe for both the mother and the child. It is performed early, then helps you find these conditions before the other tests currently available, allowing mother and physician to draw the best therapeutic strategies. It has also proven to be extremely accurate in early tests.
The test is not yet available for pregnant women as it requires additional testing before it can be offered as a diagnostic test. c
Currently, it is at the TRL-4 "technology validated in the laboratory" state. The test was developed by training a complex mathematical model to classify the metabolomic profiles obtained from the analysis of maternal blood as belonging to mother with a healthy fetus or mothers with a malformed fetus. This is a "case-control" study. Before it can be marketed, the MAMA Test should be tested on a vast population where there are no certainties about the State of health of the fetuses and the results must be verified after childbirth. This diagnostic clinical trial is needed to reach the TRL8 level, to obtain validation of the test and, then, its recognition by the ISS and other international bodies.
The clinical trial
Currently researchers are involved, on the one hand, in a complex operation of clinical trial and technical infrastructure design, required to conduct this study and, secondly, they are collecting the necessary funds to carry out this last important effort. The clinical trial will start most likely at the beginning of 2016, and will last for 36 months.
At the end of the trial, the MAMA Test could completely revolutionize the medical approach to the management of pregnant women, making it easier and safer a loosening of diagnostic pressure on pregnant women and making less use of invasive and dangerous techniques.
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