PrePsia™ Preeclampsia test
The Clinical Laboratory Innovation unit in Trinity Biotech is developing PrePsia™, an early pregnancy preterm preeclampsia risk assessment test.PrePsia™ will be
- a simple blood test which can be offered from accredited clinical laboratories
- a low cost-high throughput test, suitable for population screening
- intended for all singleton pregnancies and will be applicable at 11+0 – 13+6 weeks of gestation
- aligned with clinical guidelines which call for assessing preeclampsia risk early in pregnancy
- aligned with clinical guidelines with regards to aspirin prohylaxis in pregnancies at risk of preeclampsia
- aligned with optimal timing to start aspirin, i.e., before 16 weeks of gestation
- providing health professionals with additional information to guide pregnant women to the right prenatal care pathway.
The Clinical Laboratory Innovation unit in Trinity Biotech is developing PrePsia™, an early pregnancy preterm preeclampsia risk assessment test.PrePsia™ will be
- a simple blood test which can be offered from accredited clinical laboratories
- a low cost-high throughput test, suitable for population screening
- intended for all singleton pregnancies and will be applicable at 11+0 – 13+6 weeks of gestation
- aligned with clinical guidelines which call for assessing preeclampsia risk early in pregnancy
- aligned with clinical guidelines with regards to aspirin prohylaxis in pregnancies at risk of preeclampsia
- aligned with optimal timing to start aspirin, i.e., before 16 weeks of gestation
- providing health professionals with additional information to guide pregnant women to the right prenatal care pathway.
PrePsia™ is:
- based on >10 years of dedicated translational research focused on developing robust risk prediction screening tests based on multi-biomarker models.
- assessing a pregnant woman’s risk of developing preterm preeclampsia better by complementing readily accessible maternal information, blood pressure and a placental growth factor analysis with metabolomics technology
- underpinned by peer reviewed collaborative research with leading clinicians in the fields of pregnancy complications and prenatal screening solutions; https://metabolomicdiagnostics.com/our-research/
- underpinned by a strong IP portfolio covering use of biomarkers and biomarker analysis technology
- underpinned by proprietary machine learning based risk assessment algorithms
- is uniquely using metabolite biomarkers to personalise risk assessment
Trinity Biotech intends to offer PrePsia™ first to the US market through Immco Diagnostics, its New York State-based Immco reference laboratory following PrePsia™ approval by New York State Department of Health.
PrePsia™ is the first Trinity Biotech test originating from Metabolomic Diagnostics, Trinity Biotech’s in-house diagnostics innovation laboratory specialised in combining advanced biomarker analyses with machine learning to create novel, actionable diagnostic solutions.
What is Preeclampsia?
Preeclampsia is a disorder unique to human pregnancy. It can develop after the 20th week of pregnancy and is clinically diagnosed by
- persistent high blood pressure that develops during pregnancy or the postpartum period together with one or more of the below other diagnostic criteria
- Proteinuria, which is the presence of high levels of protein in the urine OR
- the new onset of
- thrombocytopenia, a decrease in blood platelets,
- renal insufficiency,
- impaired liver function,
- pulmonary edema, which is the presence of fluids in the lungs,
- headache unresponsive to medication and not accounted for by alternative diagnoses
- visual symptoms
Most women with preeclampsia will deliver healthy babies and fully recover. However, some women will experience health complications, several of which may be life-threatening to mother and/or baby. A woman’s condition can progress to severe preeclampsia very quickly. The rate of preeclampsia in the US has increased 25% in the last two decades and is a leading cause of maternal and infant illness and death.
Testing in patients with suspected Preeclampsia
When preeclampsia is diagnosed, there is currently no other treatment available than delivery of the baby. When the pregnancy is at term, obstetricians will typically advice to deliver the baby as soon as possible to prevent life-threatening complications occurring.
When preeclampsia is suspected well before term, clinicians and parents-to-be will have to balance the risks associated with prematurity with the risks to the mother associated with prolonged preeclampsia. Fortunately, there is a blood test available which can be used by clinicians as an aid in risk assessing whether the preeclampsia will develop in preeclampsia with severe feature or not. In the US, Trinity Biotech offers this testing service to maternity hospitals through Immco Diagnostics, its Clinical Reference Laboratory in Buffalo, NY: https://www.immco.com/preeclampsia-testing/
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