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While Sera's previous validation work focused on the 37 and 35 week time points, the 32 week mark is perhaps most crucial in terms of patient outcomes.
The company has identified progesterone metabolites linked to preterm birth and is looking to develop them for predicting risk of delivery prior to 32 weeks.
The company said it will use the proceeds to increase commercialization of its PreTRM test, a blood biomarker test to determine the risk of premature delivery.
The research team said that its diagnostic biomarkers may help clinicians differentiate a fatal disease for preterm infants from other confounding conditions.
Newly discovered biomarkers of preterm birth risk — D-lactic acid and TIMP-1 — may lead to a simple ELISA test at the point of care, its developers said.
The companies plan to explore opportunities to use Thermo Fisher's LC-MS instrumentation to develop tools to determine the risk for adverse pregnancy outcomes.
NYU Winthrop has granted Progenity an exclusive license to patents that it holds covering a biomarker for predicting preterm births.
The firm has launched a 2,300-subject prospective study evaluating the test, which measures exosome proteins to assess a woman's risk of preterm delivery.
Milu will help launch the test in countries including China as it works to develop a diagnostics business in Asia targeting maternal and women's health.
With the approval Sera is permitted to provide lab testing services ordered by a medical professional for use by pregnant women in all US states.