Saturday, 23 March 2019

DiabetOmics launches rapid POC test for Preeclampsia Assessment

07 February 2019 | News

Lumella provides an accurate and reliable estimate of Glycosylated Fibronectin (GlyFN) - a protein biomarker that is elevated in pregnant women with a high risk for developing Preeclampsia.

Preeclampsia, characterized as a hypertensive disorder, is an undesirable complication in pregnancy and can affect both the mother and the baby. It is a complex disease a: nd affects multiple organs and systems in the pregnant woman. If not detected early or not managed in time, severe preeclampsia can result in maternal and infant mortality. Preeclampsia generally occurs after the 20th week of gestation and can sometimes occur even a couple of weeks after child birth.  In woman with certain high risk conditions, it is known to occur very early on, in the pregnancy. 

Preeclampsia is a global burden. Incidence rates vary from as low as 2% in the developed countries to as high as 18% in parts of Africa. In Latin America, preeclampsia is the #1 cause of maternal mortality. Ten million women develop preeclampsia each year around the world. Worldwide about 76,000 pregnant women die each year from preeclampsia and related hypertensive disorders. The number of babies who die from these disorders is thought to be on the order of 500,000 per annum. In developing countries, a woman is seven times as likely to develop preeclampsia than a woman in a developed country. 10-25% of these cases will result in maternal death. 

In India, Preeclampsia is reported to be between 8-10% of the 28 Million pregnancies each year.    About 3.5 Million babies are born prematurely in India every year. 45-50% of preterm births are due to unknown causes, 15-20% of these preterm births are due to medically induced or elective pre-term deliveries. 

For early detection and timely management of Preeclampsia, antenatal clinics with all facilities capable of dealing with high risk pregnancies, along with trained manpower is an important requirement.   

DiabetOmics,  a global medical diagnostic company headquartered in Portland, USA,   understanding the need for early and reliable assessment of preeclampsia,  has launched a new, first-of-its kind, rapid, point-of-care,  test -  Lumella. Lumella provides an accurate and reliable estimate of Glycosylated Fibronectin (GlyFN) - a protein biomarker that is elevated in pregnant women with a high risk for developing Preeclampsia. Lumella is a proprietary test developed by DiabetOmics through extensive research. It uses a simple test strip (similar to home pregnancy test kit) and a hand-held quantitative reader. The test can be done with a finger prick blood sample and can be done in the physician’s clinic. Test results are available in 10 minutes and therefore the assessment can be completed within the same visit of the pregnant woman to consult with her Obstetrician. The test being simple and easy to use,  enables its adoption in any setting – remote,  rural or urban.   The Lumella test system,  has recently received regulatory approval in India,  said Dr Srinivas Nagalla,  Founder & CEO of DiabetOmics Inc., 

On the launch occasion,  Varaprasad Reddy,  Chairman of DiabetOmics,  unveiled their first product,  Lumella test for Preeclampsia.  The first Lumella test systems were handed over  to  (1)  Dr. Ramesh Kancherla,  Chairman & Managing Director of Rainbow Hospitals, Hyderabad,   (2) Dr. Swapna Yendru,  Director of Swapna Healthcare,  Hyderabad,   and (3) Dr. Sridhar,  Managing Director of an Obgyn Hospital in Kakinada.  

Dr. Shanthakumari,  Immediate Past Chairperson of Indian College of Obstetricians and Gynaecologists (ICOG) presided over the function and outlined the magnitude of Preeclampsia in India.  Dr. Pratibha,   Retd Professor and HOD of Dept of Obgyn, Osmania Medical College, Hyderabad,  briefed about the situation in a public health setting. 

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