Pronota’s Risk Stratification Test Breaks New Ground in the Early Detection of Pre-term Pre-eclamp­sia Cases in SCOPE Consortium Study

Ghent, Belgium, July 9, 2012. Pronota NV, a com­pa­ny ded­i­cat­ed to the devel­op­ment of best-in-class diag­nos­tics for ear­ly detec­tion of life-threat­en­ing con­di­tions, announced today that it has suc­cess­ful­ly val­i­dat­ed its mid-ges­ta­tion pre-eclamp­sia screen­ing test. This test cor­rect­ly iden­ti­fies 80% of women at risk for the devel­op­ment of pre-term pre-eclamp­sia accord­ing to a study in col­lab­o­ra­tion with the SCreening fOr Pregnancy Endpoints (SCOPE) Consortium, one of the largest inter­na­tion­al research efforts ded­i­cat­ed to the pre­dic­tion of late preg­nan­cy dis­eases.
Pre-eclamp­sia is respon­si­ble for 50,000 mater­nal deaths annu­al­ly and is a major cause of pre­ma­ture and still births. This poten­tial­ly dev­as­tat­ing con­di­tion is unique to preg­nan­cy and pri­mar­i­ly affects women who are preg­nant for the first time. Between 4 and 7% of healthy women have their first preg­nan­cy com­pli­cat­ed with pre-eclamp­sia with no pri­or pre­dis­po­si­tion or warn­ing signs. Pronota’s assay, which com­bines five pro­tein bio­mark­ers and blood pres­sure, offers an improve­ment to exist­ing tests.
Dr. Philip Baker, Professor of Obstetrics and Gynaecology at the University of Alberta, com­ment­ed: “A test that cor­rect­ly iden­ti­fies women at risk of pre-eclamp­sia could allow physi­cians to adapt pre­na­tal care and lead to improved out­comes for both moth­ers and infants.”
Pronota used its pro­pri­etary pro­teomics plat­forms to iden­ti­fy, ver­i­fy and val­i­date a pan­el of nov­el blood bio­mark­ers which are pre­dic­tive of pre-eclamp­sia at the mid-ges­ta­tion time point. An unbi­ased large scale pro­teomics bio­mark­er dis­cov­ery exper­i­ment was fol­lowed by ver­i­fi­ca­tion of the results in 300 women who either sub­se­quent­ly devel­oped pre-eclamp­sia or did not. The pre­dic­tive mer­it of the bio­mark­er pan­el was sub­se­quent­ly con­firmed in anoth­er study of 300 women from a dif­fer­ent pop­u­la­tion. In this val­i­da­tion study, the screen­ing test iden­ti­fied 80% of the women who devel­oped pre-eclamp­sia that result­ed in birth of a pre­ma­ture baby (preterm pre-eclamp­sia). These MS based results were suc­cess­ful­ly trans­lat­ed to an ELISA type read out. This impor­tant mile­stone was achieved through a long­stand­ing sci­en­tif­ic col­lab­o­ra­tion with Professor Baker from the University of Alberta, Professor North from King’s College, London and Dr. Myers from Manchester Maternal & Fetal Health Research Centre, UK.
Professor North from King’s College, London com­ment­ed: “The pre­dic­tion mod­el devel­oped in this study rep­re­sents a rare exam­ple of a rig­or­ous­ly val­i­dat­ed pro­teom­ic bio­mark­er study, the find­ings of which have the poten­tial to be trans­lat­ed into a clin­i­cal pre­dic­tion tool.”
The cohort used for the study was com­piled by the SCOPE Consortium who col­lect­ed blood sam­ples and gath­ered med­ical and lifestyle infor­ma­tion from 5,600 women in six cen­tres across Australia, New Zealand, the UK and the Republic of Ireland over eight years. This con­trolled prospec­tive study using high qual­i­ty plas­ma sam­ples and clin­i­cal data allowed for the rig­or­ous and step­wise val­i­da­tion of Pronota’s test.
Dr. Jenny Myers, Clinical Senior Lecturer, Manchester Maternal & Fetal Health Research Centre, UK, will present a dis­cus­sion of the Pronota-SCOPE study at the International Society for the Study of Hypertension in Pregnancy meet­ing in Geneva in July.
Katleen Verleysen, CEO of Pronota, said: “We are very pleased to bring for­ward a nov­el com­bi­na­tion of bio­mark­ers pre­dic­tive for pre-eclamp­sia, which will pro­vide physi­cians with the best tools to ensure the high­est qual­i­ty of care for patients. This study also val­i­dates Pronota’s approach towards bio­mark­er dis­cov­ery and val­i­da­tion, a com­pa­ny capa­ble of tak­ing unbi­ased dis­cov­ery results through to val­i­da­tion.”

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