Mount Sinai’s Samuel Lunenfeld Research Institute has partnered with Miraculins Inc. to license methods and reagents for detecting hydroxylated Hypoxia Inducible Factor 1 alpha (“HIF-1aOH”), a promising biomarker with potential in differentiating high and low risk pregnancies, including risk of preeclampsia. Miraculins Inc. is a medical diagnostic company focused on acquiring, developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs.
The technology is part of the pioneering research on preeclampsia and placental development being conducted by Dr. Isabella Caniggia, Senior Investigator at the Samuel Lunenfeld Research Institute, in collaboration with Dr. Martin Post, a Senior Scientist at The Hospital for Sick Children. Dr. Caniggia is also a member of Miraculins’ Scientific Advisory Board and is cross-appointed at the University of Toronto as a Professor in Obstetrics and Gynecology as well as Physiology.
“Since HIF-1a is central to proper placental development, early detection of abnormal HIF-1a regulatory mechanisms could one day provide tools to physicians and caregivers to differentiate high and low risk pregnancies,” says Dr. Caniggia, the discoverer of the biomarkers and inventor of the HIF-1aOH technology. “Although HIF-1a itself is a very promising biomarker, the hydroxylated form may prove to be important to diagnosing the severity of preeclampsia and to better manage this disease throughout pregnancy.”
In addition to its promise in maternal health and preeclampsia, HIF-1aOH also presents an opportunity as a cancer biomarker and of further note, the license will include unique monoclonal antibodies highly sensitive to HIF-1aOH and the exclusive rights to manufacture reagents that measure the biomarker using materials developed by Dr. Caniggia. Miraculins is currently advancing a development plan for a kit to detect and measure HIF-1aOH in bodily fluid, which if successful could lead to a near term commercial research use product and allow for more widespread research into the utility of this novel biomarker. The ultimate goal for the biomarker development program would be worldwide sales of the biomarker technology, either alone or in combination with other markers, in a diagnostic kit for the early detection of preeclampsia or as a pregnancy risk assessment tool.
Dr. Caniggia adds, “I am very eager to expand our continued work with the Miraculins team to achieve the goal of better outcomes for mothers and babies.”
Dr. Isabella Caniggia's research has provided strong evidence that preeclampsia is characterized by abnormal placenta formation leading to persistent low oxygen being delivered to the developing fetus during pregnancy. A primary protein in this mechanism is HIF-1, a key regulator of the response to this low oxygen setting and an activator of expression of the often-noted protein biomarker Endoglin. A subunit of HIF-1, known as HIF-1 alpha (HIF-1a), is a key marker in Miraculins’ preeclampsia suite and part of a well-characterized pathway involved in preeclampsia. The hydroxylated form of HIF-1a (HIF-1aOH), a form which appears as part of the elimination of HIF-1a from the system, represents a novel biomarker with potential for use in developing diagnostic assays, or risk assessment tools, for the early detection of preeclampsia.
Preeclampsia affects 3 million mothers worldwide every year and is associated with premature births and infant illness including cerebral palsy, blindness, epilepsy, deafness and lung conditions. There is no effective detection method for the risk of preeclampsia and the cause is unknown. It is estimated that preeclampsia costs the global health care system US$3 billion per year.