Revolutionary ‘pregnancy tester’ to help UK's 1m undiagnosed kidney disease cases

A new medical device which combines nanotechnology with a pregnancy tester could help diagnose and treat the 1 million people in the UK who don’t know they have kidney disease, a new report by the Institution of Mechanical Engineers reveals today.

Developed by engineers in London, the £10 device can be used at home and could revolutionise kidney disease care in the UK, which currently costs the NHS over £1.4 billion - more than breast, lung, colon and skin cancer combined.

Created by Bio Nano Consulting, the device – called quantitative electrochemical lateral flow assay (QELFA) – uses nanoparticles to test the patient’s urine giving results in seconds and is linked to their surgery via mobile technology so doctors can track how the disease is developing.

The Institution’s new report – Nanotechnology: The Societal Impact of the Invisible – highlights the enormous potential for nanotechnology in our society but calls on the Government to increase funding for nanotech development to ensure the UK does not fall behind other nations.

Report author Dr Helen Meese, Head of Materials at the Institution of Mechanical Engineers, said:

“Nanotechnology could revolutionise the way we live our lives – it can be used in everything from food and healthcare to electronics, clothing and cosmetics.  But despite its 40 years in the public domain, the nanotechnology industry is still failing to engage with society in an open and clear way, and governments continue to lack impetus in committing to international regulation. The UK Government must provide more funding to ensure that the UK benefits fully from nanotechnology’s potential.

“The QELFA device is a brilliant example of what’s possible. Using an old technology like a pregnancy tester and combining it with nanotechnology, you have a device which could not only diagnose the million people in the UK who are unaware they have kidney disease, but also help doctors effectively monitor those undergoing treatment. It could also save the NHS millions of pounds a year.

“But although the UK has been at the forefront of nanotechnology development, we still lag behind in its commercialisation and many people are still unsure of its potential. We must change this.”

Every day 19 people in the UK are diagnosed with kidney failure yet there is currently no device that can be used by doctors for day-to-day monitoring of kidney disease. Four of these people will not have been known to specialist services for sufficient time to prepare for their treatment. After 90 days one of them will have died, two will have had a transplant, and the remaining 16 will be receiving dialysis treatment at a cost of over £25,000 per year. Many more will have a lesser degree of kidney dysfunction that will place them at increased risk of cardiovascular disease and acute kidney injury.

Nanotechnology is the manipulation of matter at an atomic level. A tennis ball, for example, is 100,000,000 nanometres across, and many have heralded the technology as the new industrial revolution.

In today’s report, the Institution of Mechanical Engineers recommends that:

• Government: Revises its existing strategic plan on nanotechnology immediately, to reflect the significant changes that have taken place in nanotechnology regulation in the past 5 years, and commits to match the current EU funding of £36.5m for a further 3 years

• The Profession: Works with Government and non-technical sectors such as the media to create a well-defined forum for public awareness and open dialogue on emerging technologies.

• Industry: Creates a number of ‘Industry Champions’ whose aim is to pull the research through to the commercial product. These high-profile nanotechnology advocates would act as a catalyst to bring together fundamental research and commerce and identify high value markets where technical demonstrators and proof-of-concept could be developed.

New pregnancy risk for babies and moms

Pregnant women who are overweight with moderately elevated blood sugar never set off any alarms for their physicians. The big concern was for women who were obese or who had gestational diabetes because those conditions are known to cause a host of health risks to the mom and baby. But a new study shows these women who are just above average for weight and blood sugar are at a higher risk of bad pregnancy outcomes than previously known. In fact, this group is at higher risk than pregnant women who are obese with normal blood sugar or pregnant women who have gestational diabetes and a normal weight.
"These are women who have not been on our radar because they don't have gestational diabetes and aren't obese, but our study shows if you are one step away from each of those, you carry some significant risks," said principle investigator Boyd Metzger, M.D., a professor of medicine-endocrinology at Northwestern University Feinberg School of Medicine and a physician at Northwestern Memorial Hospital. "We need to address the combination of overweight and blood sugar of these women as urgently as we do for women who are obese or have gestational diabetes."
This group of women comprised about 6 percent of the total number of women in the study. Obese women made up 16 percent of the group and those with gestational diabetes accounted for 13.7 percent.
The study also found women who are both obese and have gestational diabetes are at a much higher risk of having an adverse pregnancy than women having only one of those conditions.
The paper, published in the April issue of Diabetes Care, is from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study and includes 23,316 women from nine countries.
One of the adverse outcomes for these mothers is having large babies, the result of fat accumulation. Large babies increase the risk of injury to the baby during vaginal delivery, increasing the likelihood of a Caesarean section.
The study found when the mothers are obese and have gestational diabetes, the babies weigh 340 grams more than babies of mothers with normal weight and blood sugar. When the mothers are overweight (but not obese) with above-average blood sugar levels, the babies weigh 214 grams more. Mothers of normal weight but with gestational diabetes have babies who weigh 164 grams more. And obese mothers with normal glucose levels have babies with an increased weight of 174 grams.
A pregnant woman's higher blood sugar level and weight also can lead to higher insulin and lower blood sugar levels in a newborn. In turn, these effects may eventually trigger obesity and diabetes, perhaps as early as childhood.
"The big message from this is when you look at the impact of nutrition, metabolism and weight on pregnancy outcomes, every woman - on her first prenatal visit -- should get a prescription for a session with a dietician and an appropriate healthy eating plan for her pregnancy," said Metzger, also the Tom D. Spies Professor of Metabolism and Nutrition at Northwestern's Feinberg School. "This doesn't happen, but it should, and insurance companies should reimburse it."

**Source: Northwestern University

Intimate partner violence during pregnancy

--Background
Partner violence against women is common during pregnancy and might have an adverse effect on the mental health of women after delivery. We aimed to investigate the association of postnatal depression with psychological, physical, and sexual violence against women by their intimate partners during pregnancy.

--Methods
In a prospective cohort study undertaken in Recife, northeastern Brazil, between July, 2005, and December, 2006, we enrolled pregnant women (aged 18—49 years) in their third trimester of pregnancy who were attending primary health-care clinics. The women were interviewed during pregnancy and after delivery. The form of partner violence in pregnancy was assessed with a validated questionnaire, and the Edinburgh postnatal depression scale was used to measure postnatal depression. Associations were estimated with odds ratios (ORs), adjusted for confounding factors contributing to the association between postnatal depression and intimate partner violence.

--Findings
1133 pregnant women were eligible for inclusion in the study, of whom 1045 had complete data for all variables and were included in the analysis. 270 women (25·8%, 95% CI 23·2—28·6) had postnatal depression. The most common form of partner violence was psychological (294 [28·1%, 25·4—31·0]). Frequency of psychological violence during pregnancy was positively associated with occurrence of postnatal depression, and although this association was attenuated after adjustment, women reporting the highest frequency of psychological violence were more likely to have postnatal depression even after adjustment (adjusted OR 2·29, 95% CI 1·15—4·57). Women who reported physical or sexual violence in pregnancy were more likely to develop postnatal depression (OR 3·28, 2·29—4·70), but this association was substantially reduced after adjustment for psychological violence and confounding factors.

--Interpretation
Psychological violence during pregnancy by an intimate partner is strongly associated with postnatal depression, independently of physical or sexual violence. This finding has important policy implications since most social policies focus on prevention and treatment of physical violence.

--Funding
Departamento de Ciência e Tecnologia da Secretaria de Ciência, Tecnologia, e Insumos Estratégicos, and Conselho Nacional de Desenvolvimento Científico e Tecnológico (Brazil).

**Published in "The Lancet"

Cheap and simple, non-invasive blood test could replace invasive diagnostic techniques in early pregnancy

Researchers in The Netherlands believe they are on the verge of developing a simple, prenatal blood test that would be able to detect accurately chromosomal abnormalities in the developing foetus. At present, the only reliable way to do this is through amniocentesis or chorionic villus sampling, both of which are invasive and carry the risk of triggering a miscarriage.
Dr Suzanna Frints, a clinical geneticist at Maastricht University Medical Centre (Maastricht, The Netherlands), will tell the 26th annual meeting of the European Society of Human Reproduction and Embryology in Rome today (Tuesday), that she and her colleagues have been able to use molecular genetic probes to detect DNA belonging to the foetus in blood samples taken from pregnant women.
So far, they have been successful in identifying DNA from the Y chromosome, indicating that the foetus is a boy and therefore could be at risk of inheriting an X-linked disorder such as Duchenne’s muscular dystrophy and haemophilia.

The researchers believe the same method can be used to detect trisomy 21 (where an extra chromosome 21 causes Down’s syndrome) and they are investigating this next, followed by trisomy 13 and 18 (responsible for causing Patau and Edward’s syndromes respectively). [2]
Dr Frints and her colleagues are using the "Multiplex Ligation-dependent Probe Amplification" (MLPA), technique to detect foetal DNA that is present in the blood of women who have been pregnant for at least six to eight weeks. The MLPA test is part of an existing kit that is already used around the world to detect chromosomal abnormalities in invasively obtained amniotic fluid or chorionic villi samples from pregnant women. The kit is cheap and fast, delivering results within 24-62 hours, but, until now, it has only been used on samples taken during invasive procedures; it was not known whether it would work on cell free foetal DNA circulating in blood samples of pregnant women.
"It is inexpensive compared to the costs of invasive prenatal diagnosis, and could easily be implemented at low cost, between 30-150 Euros per kit per person, with a small apparatus in every hospital in the world. Blood samples can be taken during routine antenatal visits," said Dr Frints.
The study started in 2009 and is expected to continue to 2012 or longer. The researchers are recruiting women who are at high risk of an abnormal pregnancy and undergoing prenatal screening and invasive diagnostic procedures. To obtain MLPA proof of principle, they have recruited 14 women who had a pregnancy termination between 14-22 weeks gestation because of trisomy 13, 18 or 21 detected by invasive prenatal diagnosis (group A), four women who had non-invasive prenatal screening at 12-14 weeks gestation (group B), three women who had invasive prenatal diagnosis because of being at least 36 years old (group C), and nine non-pregnant control women who had had up to three children (group D). A total of 20, 715, 40 and 30 women are needed in each group respectively to complete the clinical trial to test the reliability of the MLPA technique.
"The MLPA test results obtained in 2009 were compared with the results of amniocentesis, chorionic villus sampling and pregnancy outcome. All but one sample correlated with the non-invasive MLPA test results, detecting foetal Y-chromosome sequences," said Dr Frints. "At the moment, the reliability of the test is about 80% due to false negative results, but we are working to improve the accuracy of the MLPA probe.
"Although we need to test and refine this MLPA technique further, our results so far are promising. This is innovative translational research and when we succeed in developing the MLPA procedure for use in maternal blood, we will be able to offer a safe, cheap, fast, reliable and accurate non-invasive test, which will be of immediate benefit to pregnant women, young and old, all over the world."
The researchers hope the test may be available in the clinic in two to five years’ time.

Overweight women undertaking ART twice as likely to miscarry as their slimmer counterparts

Being overweight leads to a greater risk of miscarriage for patients undergoing assisted reproductive technology (ART), the 26th annual conference of the European Society of Human Reproduction and Embryology heard today (Monday). Dr. Vivian Rittenberg, a Clinical Fellow in the Assisted Conception Unit, Guy’s and St. Thomas’ Hospital NHS Foundation Trust, London, UK, said that her research provided additional evidence to show that increased body mass index (BMI) was independently associated with a higher miscarriage rate after IVF or ICSI treatment. This information should be included in the counselling given to patients before they undertake ART, she said.
Dr. Rittenberg and colleagues analysed all pregnancies arising after single blastocyst (five-day embryo) transfer (SBT) performed in their clinic over a four year period, between January 2006 and December 2009. The 318 women were divided into two groups according to their BMI at the start of their treatment cycle. One group of 185 women had BMI in the normal range, from 18.5-24.9, and the other group (133 women) was made up of those who had a BMI of 25 or above. Of this group, 19 (14%) were obese, defined as having a BMI of 30 or more.
Overall, 26% of women miscarried before 20 weeks gestation. The researchers found that the miscarriage rate was significantly lower in women with normal weight (22%) compared to women who were overweight (33%). After adjusting for other variables that might have skewed the results such as age, duration of infertility, smoking and a history of previous miscarriage, they were able to show that being overweight or obese more than doubled the risk of miscarriage.
"Although there is evidence that miscarriage rates are higher in overweight women who conceive spontaneously, there were conflicting views about the effect of increased weight on the outcome of pregnancies occurring after IVF and ICSI," Dr. Rittenberg said. "The difficulty of interpreting the studies to date is that they are heterogeneous, their thresholds for defining obesity vary, and they assess the outcome in relation to BMI following the transfer of multiple embryos at various stages of development. Our study differs in that we transferred only one embryo at a specific stage of development, and were therefore able to provide clear evidence of the deleterious effect of being overweight on the chances of miscarriage."
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Being overweight can lead to a number of other pregnancy risks including high blood pressure, pre-eclampsia, diabetes, premature delivery and post-partum bleeding. Besides the inherent medical dangers of these conditions, they can lead to lengthy hospital stays for the pregnant woman. Additionally, babies of obese mothers are more likely to have a high birth weight and thus may face an increased rate of delivery by Caesarean section, which in itself can cause complications for both mother and baby.
"Overweight women wishing to get pregnant by spontaneous conception are already counselled to lose weight before trying for a baby," said Dr. Tarek El-Toukhy, Consultant in Reproductive Medicine at the Assisted Conception Unit, Guy’s and St. Thomas’ Hospital NHS Foundation Trust, London, UK, who led the study. "Our findings have shown clearly that women undertaking ART should be strongly encouraged to heed this advice in order that they can have the best possible chance of obtaining and maintaining a pregnancy."