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Developing robotic preeclampsia diagnostics with the delfia series and the placenta protein 13 (pp13) biomarker

Delfia kits for 1st trimester preeclampsia (5-7% of pregnancies) tests will be developed with europium fluorometry & computerised robotic arms for accurate & fast testing. Verified clinically, and fda & ce registered, the kit will improve patient access & enhance sales for women's health.

Preeclampsia, a multi-system disorder, complicates 5-7% of all pregnancies, and is responsible for 18% of maternal deaths during pregnancy and for 1/3 of prematurity. Preterm preeclampsia affects newborns that often suffer lifelong from major motor and cognitive disabilities and blindness. In addition they are at increased risk for developing diabetes and cardio-vascular diseases. The toll on obstetrics and paediatric expenditure is very high (approximately 30 million dollars annually in the U.S.A.). The complex disorder, expressed as a newly onset hypertension developed in previously normotensive women after 20 weeks of gestation along with protein loss in the urine, is coupled to complications of the liver and blood system and if it affects the brain can lead to convulsions and stroke. While clinically diagnosed after the second half of pregnancy, the underlying patho-physiology is associated with deleterious alterations of implantation and placentation already starting in the first trimester. In this project we propose to develop kits for robotic systems that incorporate placenta protein 13 (PP13) as a first trimester non-invasive marker, integrated with the power of the series of DELFIA (Dissociation, Enhanced, Lanthanide Fluoro-Immuno-Assay) platforms, and leverage on the prediction power of PP13 for the high-throughput, robust, automated DELFIA platforms for early detection, thus optimising therapies for preventing preeclampsia or reducing its severity. Our working hypothesis: First trimester markers are the key for diagnosis. They enable subsequent close surveillance and tailored putative medications for preventing preeclampsia. DIAGNOSTIC TECHNOLOGIES from ISRAEL already demonstrated PP13 as a first trimester marker and developed ELISA (Enzyme-Linked Immuno-Sorbent Assay) plates for measuring its effectiveness as a marker. WALLAC is a world leader in prenatal diagnosis providing means and tools for diversified clients and emphasising the importance of first trimester testing. Together the parties intend to upgrade the ELISA kits to meet client requirements for robust testing and adjust the markers and their specific antibodies coupled with the Europium fluorescence detection technology and software of WALLAC and the diversified platforms of the automated DELFIA systems, to enable high throughput testing platforms for first trimester assessment of the risk of developing preeclampsia. The parties have direct access to large stored specimen banks and to new patient enrolment, enabling verification of the proposed product to be developed. Out tasks are as follows: 1. Upgrade the current PP13 ELISA kits to fit GMP (Good Manufacturing Process) requirements of the U.S. FDA (Food and Drug Administration). 2. Develop new PP13 kits for the DELFIA platform based on the Europium fluorescence technology and turn them into a commercially viable product. 3. Design and conduct nested case-control clinical trials with samples stored by the two parties comparing the ELISA and the DELFIA kits according to good clinical practice, correct clinical definitions, ethics and logistics. 4. Develop the proper algorithm for the DELFIA analysis software required for determining the effectiveness of PP13. 5. Develop a Concept Medical Importance concept with Opinion Leaders to be later adopted by the sales force in order to generate economic growth ensuing from the project implementing principles of good manufacturing and laboratory practice. Our two companies have already cooperated in testing PP13 with the current ELISA kits for first trimester prenatal screening. WALLAC is a world leader in prenatal testing and together we intend to be ready to lead from the research and clinical study bench into education and training programmes and into successful implementation of prenatal screening of preeclampsia worldwide. The WALLAC DELFIA (Dissociation, Enhanced, Lanthanide Fluoro-Immuno-Assay) platforms are the leading non-radioactive systems for high throughput prenatal testing. The label employs the chelates of europium or other lanthanide metals, while time-resolved fluorometry (TRF) is used to measure the signal. Lanthanides have large Stokes shifts and a long decay time. The product attributes are: - High sensitivity. - Wide dynamic range of measurements. - Reproducibility. - No radioactivity. - Reagents and labelled compounds with a long shelf life. - The use of multiple labels. The unique properties of Lanthanide chelates are: * Eu3+ >500 microseconds * Sm3+ >50 microseconds * Background 0.01 microseconds * No disturbing background in time-resolved fluorescence. Several models of the DELFIA have been advanced to become fully automated, computer controlled and perform for high-throughput laboratory systems. In summary the DELFIA platforms offer: - High sensitivity. - Wide dynamic range. - Low background fluorescence. - Large Stokes shift. - Long fluorescence decay time. - Full automation with AutoDELFIA(TM). - High throughput. - Walk-away operation. In this project our goal is to turn the ELISA semi-manual-man-controlled kits into the more accurate, repeatable, computer controlled version that can be incorporated into the various DELFIA platforms to enable the reliable and accurate detection of the risk of developing preeclampsia using the PP13 as a biomarker. Keywords: fluorometry, preeclampsia, immunodiagnostic, computer-controlled robotic system.
Acronym: 
RPT
Project ID: 
3 808
Start date: 
01-09-2006
Project Duration: 
40months
Project costs: 
2 000 000.00€
Technological Area: 
Diagnostics, Diagnosis
Market Area: 
Diagnostic test products and equipment

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