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Patent
Perkin Elmer Corporation, Foundation Medicine and Wallac Oy | Date: 2013-12-31

The disclosure relates to methods, medical profiles, kits and apparatus for use in determining the risk that a pregnant individual has for developing pre-eclampsia based on amounts of certain biochemical markers in a biological sample from the individual and biophysical markers. The disclosure also relates to methods, medical profiles, kits and apparatus for use in determining the risk that a pregnant individual is carrying a fetus having a chromosomal abnormality based on amounts of certain biochemical markers in a biological sample from the individual and biophysical markers.


Patent
Perkin Elmer Corporation, Wallac Oy and Foundation Medicine | Date: 2015-11-13

The disclosure relates to methods, medical profiles, kits and apparatus for use in determining the risk that a pregnant individual has for developing pre-eclampsia based on amounts of certain biochemical markers in a biological sample from the individual and biophysical markers. The disclosure also relates to methods, medical profiles, kits and apparatus for use in determining the risk that a pregnant individual is carrying a fetus having a chromosomal abnormality based on amounts of certain biochemical markers in a biological sample from the individual and biophysical markers.


Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.0-1 | Award Amount: 7.64M | Year: 2013

Project ASPRE is a commercially led development project that aims to boost translation of the results of PREGENESYS (FP6 EU #37244) into effective applications for prenatal care. PREGENESYS has identified several biomarkers for early (11-13 weeks gestation) and effective identification of pregnancies at high risk of developing pre-eclampsia (PE). This disorder affects 2-8% of pregnant women and is a major cause of short- and long-term maternal and perinatal morbidity and mortality. Studies under PREGENESYS using in-vitro research methods suggested that aspirin is the most promising agent for preventing PE. Evidence from small clinical studies has indicated that prophylactic use of low-dose aspirin starting before 16 weeks gestation can potentially halve the PE prevalence and its associated complications. Objectives: Widespread clinical implementation of a strategy of screening and prevention of PE: (1) Reduce the prevalence of PE requiring delivery before 37 weeks (preterm PE) by at least 50%, (2) Demonstrate through a large multicentre screening and prevention study the acceptability, uptake and efficacy of first trimester multi-parameter screening of preterm PE and its preventative treatment with aspirin, (3) Develop affordable, automated and reliable methods for high throughput measurement of biomarkers and commercial platforms for PE risk assessment software, (4) Develop management protocols for high risk and low risk pregnancies for PE, (5) Improve education and training of healthcare professionals involved in pregnancy care, (6) Conduct the dissemination and training required to drive clinical acceptance and adoption of multi-parameter PE screening and aspirin treatment. Expected results and impact: Generating a market demand for SME-based newly developed products for PE screening and prevention, including machines, kits and software, thereby transforming research success into economic growth for SMEs and upholding European leadership in perinatal care.


Patent
Foundation Medicine and Wallac Oy | Date: 2013-12-31

The disclosure relates to methods, medical profiles, kits and apparatus for use in determining the risk that a pregnant individual has for developing pre-eclampsia based on amounts of certain biochemical markers in a biological sample from the individual and biophysical markers. The disclosure also relates to methods, medical profiles, kits and apparatus for use in determining the risk that a pregnant individual is carrying a fetus having a chromosomal abnormality based on amounts of certain biochemical markers in a biological sample from the individual and biophysical markers.


A method for predicting risk of pre-eclampsia in a pregnant individual includes measuring one or more biochemical markers including an RBP4 biochemical marker in a blood sample obtained from the pregnant individual to determine one or more biomarker levels including an RBP4 biomarker level, identifying, for each of the one or more measured biochemical markers, a difference between the measured biomarker level and a corresponding predetermined control level, and, responsive to the identifying, determining a prediction corresponding to a relative risk of the pregnant individual having or developing pre-eclampsia.


A method for predicting risk of gestational diabetes mellitus (GDM) in a pregnant individual includes measuring one or more biochemical markers in a blood sample obtained from the pregnant individual to determine one or more biomarker levels, where the one or more measured biochemical markers includes at least one of PAI-2 and sTNFR1, identifying, for each of the one or more measured biochemical markers, a difference between the measured biomarker level and a corresponding predetermined control level, and, responsive to the identifying, determining a prediction corresponding to a relative risk of the pregnant individual having or developing GDM.


A method for predicting risk of pre-eclampsia in a pregnant individual includes measuring one or more biochemical markers including an RBP4 biochemical marker in a blood sample obtained from the pregnant individual to determine one or more biomarker levels including an RBP4 biomarker level, identifying, for each of the one or more measured biochemical markers, a difference between the measured biomarker level and a corresponding predetermined control level, and, responsive to the identifying, determining a prediction corresponding to a relative risk of the pregnant individual having or developing pre-eclampsia.


A device for managing a sample to be analyzed comprises magnetizing equipment (302) for producing magnetic field capable of interacting, when the sample is moving to or located in a sample well, with magnetically amplifying material attached to the sample, where the magnetically amplifying material has relative magnetic permeability constant greater than one. With the aid of the magnetizing element the movement of the sample to the sample well and/or the position of the sample in the sample well can be monitored and/or controlled. The device can be, for example but not necessarily, an instrument for dispensing samples to sample wells or an optical measurement instrument.


A method for cross-talk correction of intensities measured on mutually separate detection wavelength bands is presented. Each detection wavelength band relates to one of analyte-specific probe-populations contained by a sample to be analyzed. Each probe-population is capable of emitting a first signal component and a second signal component whose spectra have maxima at different wavelengths and at least the first signal component is dependent on presence of analyte detectable with that probe-population. Cross-talk corrected intensities are computed on the basis of a) the intensities measured on the detection wavelength bands, b) a value indicative of intensity occurring on an auxiliary wavelength band outside the detection wavelength bands and at least partially caused by the second signal components, and c) pre-determined cross-talk parameters. For example in con-junction with FRET-based assays, the dependency of a background signal on the percentage of hybridized probes can be taken into account in the cross-talk correction.


Patent
Wallac Oy | Date: 2016-03-22

The invention relates to a method and apparatus for detecting elution of a sample from a sample substrate to incubation buffer contained in a sample well while the sample substrate is still within the well. The method comprises measuring light absorption of the contents of the sample well at a predefined wavelength or wavelength range, and determining, based on the absorption measurement, the degree of elution of the sample. According to the invention, a wavelength or wavelength range is used which is absorbed by at least one elutable component of the sample but transmitted by the sample substrate. The invention provides a reliable way of determining the degree of elution of blood samples in neonatal screening, for example.

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