Cambridge, Mass. – May 5, 2015 – sphingotec, LLC, predictive diagnostic tests for cancer, cardiovascular diseases and kidney function, today announced the results of a survey gauging women’s understanding of breast cancer risk factors and their perceptions of common breast cancer screening methods. The survey was conducted in conjunction with a national, independent health information resource for women, and found that of the 464 anonymous respondents, the majority of women do not discuss breast cancer risk factors or the guidelines and limitations of mammography screenings with their healthcare providers.
“Mammograms remain an important screening tool and can save lives by helping detect some cases of breast cancer early, however women are not aware of the limitations of mammography, nor are they aware of their personal risk factors leading to breast cancer, according to the survey,” said Karla Gonye, president, sphingotec, LLC. “The results of the survey give us insight into the market need for breast cancer biomarkers beyond BRCA 1/2 and further indicate the desire for more risk predictive tests so that women and their doctors can make more informed decisions about their risk of breast cancer.”
New research identifies blood biomarker as decisive link between fat intake and risk for cardiovascular disesases, diabetes and obesity; spingotec‘s revolutionary sphingotest®pro-NT test measures neurotensin levels to help prevent certain diseases
Hennigsdorf, Germany – May 12, 2016
Excess weight and obesity, as well as the cardiovascular diseases and diabetes that these conditions are associated with, rank among the most widespread conditions in the world’s most developed countries. In the U.S. alone, nearly 70 percent of the population is overweight and 35 percent is obese, according to the World Health Organiztion. In an article published in the scientific journal , Swedish and U.S. researchers demonstrate the link for the very first time between neurotensin values and the development of obesity. The hormone neurotensin can show when men and women of normal weight are at risk of becoming overweight and developing the diseases associated with carrying excess weight.
Researchers at the University of Malmö in Sweden have already used two major population studies to show the link between an increased concentration of the hormone neurotensin and the risk of developing certain diseases, in particular, cardiovascular diseases, diabetes and breast cancer. Now, in their latest article published in Nature, Swedish and U.S. researchers have proven that the level of neurotensin in the blood indicates whether individuals of normal weight could become obese.
Their work shows that neurotensin holds the key to how individuals utilize and absorb fat. Long known as the “fat insulin,” neurotensin is released in the small intestine, particularly when animal fats are consumed. The results now published in Nature show that neurotensin is the decisive link between fat intake and the risk of developing certain diseases. People with a low fasting level of neurotensin tend not to become obese despite consuming fat and have a low risk of developing cardiovascular diseases, diabetes and breast cancer.
Researchers at biotechnology company sphingotec in Henningsdorf, Germany, have developed the sphingotest® pro-NT test that allows blood levels of neurotensin to be measured for the first time.
“Unlike genetic factors, the concentration of neurotensin in the blood is a variable that can change depending on eating habits and other lifestyle factors,” explains Dr. Andreas Bergmann, founder and owner of sphingotec. “People with a low neurotensin level have a better chance of living longer and staying healthy.”
Neurotensin levels can be measured as part of routine diagnostic processes using the sphingotest® pro-NT test, which is evaluated in labs using a fasting EDTA blood sample and a standard laboratory immunodiagnostic procedure (Immunoassay). For more on sphingotec and its sphingotest® pro-NT test, please visit www.sphingotec.com.
The biotechnology company sphingotec GmbH, headquartered in Hennigsdorf, Germany was founded in 2002. sphingotec aims to reduce or eliminate the risk of serious diseases such as cancer, cardiovascular diseases and kidney conditions. The process starts before the disease has actually developed: using biomarkers to indicate susceptibility for a specific disease provides healthy individuals with the knowledge that they are at risk. What makes the approach so special is that the biomarkers also create a starting point for preventative strategies at the same time, as evidence-based recommendations on how to reduce risks are always an integral part of the complete concept. Further information can be found on our website at www.sphingotec.de
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A study on centenarians links sphingotec’s biomarker bio-Adrenomedullin (bio-ADM) to longevity
Human longevity has been previously linked by researchers to genetic factors, calorie restriction, and certain life-style factors such as physical activity or the Mediterranean diet. Now, Italian researchers from La Sapienza University in Rome have identified an additional factor, which significantly contributes to a longer life. In a pilot study on some of the oldest people of the world, they discovered that the perfusion of organs and muscles of the centenarians was as efficient as that in people who were 30 years younger. Results of the CIAO (Cilento Intitiative on Aging Outcome) pilot study, presented today in the Italian town of Pollica, suggest that low blood levels of the peptide hormone Adrenomedullin (bio-ADM) are an indicator for such a good microcirculation. Making longevity measurable has long been a scientific goal as it could open up the avenue to a systematic identification of factors contributing to an extended life span.
Prof. Salvatore Di Somma and his team carried out comprehensive health and life style assessments of two study groups that live in the Cilento region, located in the province of Salerno in southern Italy: In the first were 29 so-called ‘SuperAgers’ (median age 92 years), while the second was made up of 52 younger relatives (median age 60 years, living in the same household) who are expected to live just as long because they have the same genetic background and have been exposed to the same environmental and lifestyle factors. Blood biomarker analyses were carried out by the diagnostic company sphingotec (Hennigsdorf, Germany). It measured levels of the heart-function biomarker MR-proANP, as well as a marker for kidney function (penKid) and bio-ADM. The last is a regulator of vasodilation and blood vessel integrity, which both affect blood pressure. The results were compared to those of a cohort of 194 healthy persons (median age 63.9 years), who were monitored over eight years in the earlier Malmö Preventive Project (MPP, Principal Investigator Professor Olle Melander, Lund University, Sweden).
As expected, low values of MR-proANP and penKid among the subjects in the two younger control groups indicated no signs of heart or kidney dysfunction. In contrast, both biomarkers were elevated in the SuperAgers, possibly due to the process of organ aging. However, even though the older group had levels of the two biomarkers that were as high as those found in patients experiencing heart failure (HF) or acute kidney injury (AKI), they were in clinically good condition. Surprisingly, in the group of SuperAgers, the bio-ADM values – which are often pathologically elevated in HF or AKI patients – were as low as those in both reference groups.
“Very low concentrations of this biomarker indicate a well-functioning endothelial and microcirculatory system allowing good blood perfusion of organs and muscles,“ concludes Di Somma. A good microcirculation is what makes marathon runners perform better at the same heart rate than the average man or woman on the street.
“We are excited about the connection between bio-ADM levels and a good microcirculation as an indicator for good quality of life”, says sphingotec founder Andreas Bergmann, who was instrumental in developing the bio-ADM assay. “If bio-ADM proves to be a reliable biomarker for longevity this will open up the avenue to a systematic analysis of the factors contributing to longevity“, he adds. ”We are excited to contribute to the identification of lifestyle factors ensuring a good microcirculation.”
The researchers are currently planning to extend the pilot study to 2,000 people from the Cilento region. One major goal of the follow-up study is to investigate whether certain components of the local Mediterranean diet could affect the bio-ADM level. The cuisine typical to the region traditionally uses number of plants native to the area. Another idea is to bring people with high bio-ADM levels to Cilento and measure whether the local environment has an effect on levels of the microcirculation biomarke
The CIAO (Cilento Intitiative on Aging Outcome) study was designed to identify life style, genetic and epigenetic factors contributing to longevity in the Cilento region. With an average life expectancy of 92 years for women (Italian average: 84) and 85 years for men (Italian average: 79), the Cilento has one of the world’s highest concentrations of centenarians – even higher than in Okinawa (Japan), the most intensively investigated centenarian hotspot. The contributors to the current pilot study were identified through local physicians who acquired the informed consent of their patients. A mobile bus equipped with all instrumentation for a comprehensive health assessment was used to visit the study participants. Additionally, blood samples for biomarker analysis were taken and participants were interviewed about their life style habits.
Microcirculation describes blood flow through the smallest vessels (capillaries) in the circulatory system. In these regions, oxygen and nutrients are directly delivered to cells, while metabolic debris, toxins and CO2 are winnowed out. Blood pressure and body temperature is also controlled by the microcirculation through dilation or constriction of the capillary network that penetrates muscles, organs and skin. If put end-to-end, the body’s capillaries would stretch 90,000-110,000 kilometers – more than twice the circumference of Earth. If placed side-by-side, they would cover an area the size of two football fields (500-700 sqm). On average, people have around 200-300 capillaries/mm2, but endurance athletes like runners can have up to 40% more (300-500 capillaries/mm2). This contributes to better muscle perfusion, oxygen supply and performance.
Salvatore Di Somma (63), Professor of Internal Medicine at the University La Sapienza in Rome, is the organizer of the CIAO pilot study. Strong personal links have given him unique access to the population of centenarians living in the Cilento. In previous studies, he identified rosemary as an ethnobotanically conserved part of the local Mediterranean cuisine that might could be contributing to longevity in the region. Conserved gene variants associated with longevity were also identified in Cilento’s population in the Southern Italy Centenarian Study (SICS). The variants affect insulin sensitivity (FOXOA3, CAMMIV), RNA editing (ADARB1+2) and the aromatase pathway (Cyp19, ESR1). Additionally, a unique profile of lipids in the membrane of red blood cells (erythrocytes) was identified in 2008 within the the framework of the SICS study
Centenarian hotspots: Several regions have been identified by National Geographic writer Dan Buettner as longevity hotspots. They include Okinawa (Japan), Sardinia (Italy), Nicoya (Costa Rica), Icaria (Greece) and a group of Seventh-day Adventists living in Loma Linda (US, California). The Cilento, a mountainous region 150 kilometres south from Naples, is another hotspot of centenarians. Although it didn’t earn a mention in Buettner’s book on the so-called “Blue zones” of centenarians, people who live there are getting older than in Okinawa, Japan, the world’s very best-studied longevity hot-spot. Life expectation of women living in the Cilento (92 years) is 8 years above the Italian average; and that of men (85 years) 6 years above, anyway.
Adrenomedullin is a soluble peptide hormone. Mainly released by the inner layer of blood vessels (endothelial cells), its biological function is to control vasodilation, an important regulator of blood pressure and organ perfusion. In several studies involving more than 16.000 patients, the plasma level of the bioactive Adrenomedullin (bio-ADM) has been proven to predict and provide an early diagnosis for circulation dysfunction. For instance, bio-ADM blood levels rise 2-3 days before septic shock occurs. Elevated levels of bio-ADM are a specific indicator of vasodilation and leakage from microcirculatory capillaries, which in sepsis patients subsequently lead to severe hypotension, malperfusion of organs (for which the body can’t compensate by increasing the heart rate), shock and multiple organ failure. Low bio-ADM blood levels, in contrast, are a specific indicator for an intact microcirculation, ensuring good muscle and organ blood supply without any cardiovascular stress.
Hennigsdorf-Berlin/Cologne – German diagnostics company sphingotec GmbH (Hennigsdorf) and bestbion dx GmbH (Cologne) have signed an agreement to market sphingotec’s innovative sepsis and congestive heart failure test (sphingotest® bio-ADM) and acute kidney function monitoring assay (sphingotest® penKid). Under the agreement, bestbion dx will market both biomarker assays, set to improve therapy monitoring and outcomes in intensive care units and emergency departments, in Germany and Austria.
bio-ADM is a biomarker for vascular dysfunction, which allows to predict septic shock and thus can guide treatment choices. In congestive heart failure, bio-ADM is the first biomarker that identifies patients having (residual) edema and patients at high risk to develop life-threating residual (i.e. lung) edemas, caused by incomplete response or therapy resistance to decongestion therapy with loop diuretics. Unidentified residual congestion is the major cause for re-hospitalization and post-discharge mortality in congestive heart failure patients causing 30% of deaths and global annual cost of US$39bn. penKid is a kidney function biomarker predictive for acute kidney failure (AKI), which frequently occurs in congestive heart failure patients receiving diuretics. Monitoring of congestive heart failure patients, who receive diuretics, with both, bio-ADM and penKid, thus allows physicians to prevent AKI while excluding incomplete decongestion.
sphingotest® penKid and sphingotest® bio-ADM complement bestbion dx’s portfolio of marketed assays in the area of congestive heart failure. The company already markets an assay for ST2, an innovative biomarker that detects cardiac remodeling early on and opens the avenue to early intervention and an optimized adjustment of congestive heart failure therapies.
„We are delighted that bestbion dx will distribute our acute care biomarker assays for therapy monitoring and adjustment“, said Dr. Andreas Bergmann, founder and CEO of sphingotec GmbH. „Our biomarker assays support physicians with information to monitor and adjust the diuretics therapy to the need of each individual patient suffering from congestion“.
„sphingotec’s tests complement our portfolio of marketed biomarker assays to monitor congestive heart failure“, said Werner Dummert, Sales Director of bestbion dx. „ penKid, bio-ADM and ST2 are a dream team for physicians, as they can contribute to significant improvements in the adjustment of beta-blocker and diuretics dosage in congestive heart failure and associated acute kidney injury. The collaboration with sphingotec perfectly reflects bestbion dx’s mission statement „Rescue and sustain lives“.
About congestive heart failure: About 1.8 million Germans and 250.000-300.000 Austrians suffer from congestive heart failure. The characteristic loss of pump function of the heart triggers cardiac remodeling – the heart gets stiffer, fibrotic, and cannot pump enough blood into the circulatory system. The lower pump efficacy causes lower oxygen saturation and results in congestion, which means that blood returning to the heart through the veins backs up, resulting in higher venous pressure and causing fluids to build up in the tissues (edema). About 80% of patients with congestive heart failure are at risk to develop edema, because their microvasculature becomes leaky due to venous hypertension. Physicians try to prevent the worst case – deadly lung edemas – by administration of loop diuretics, which can reduce hypertension by increasing water excretion. However, not all patients fully respond to diuretics. Incomplete response to diuretics therapy is the most common cause of re-hospitalization and post discharge mortality in patients with congestive heart failure. It’s not yet fully understood why patients with congestive heart failure often experience acute kidney injury (AKI). However, there is growing evidence that AKI can be attributed to congestion („cardio-renal syndrome“) and that, vice versa, AKI can trigger heart problems. Management of fluid balance with loop diuretics is challenging – if too much fluid is excreted from tissues, this will support development of AKI. On the other hand, if too little fluid is excreted, lung edemas could return. Besides that, a large proportion of patients with congestive heart failure does not fully respond to diuretics treatment, leading to undetected residual congestion. To date, physicians have no means to identify these patient group at discharge, resulting in high re-hospitalization and post-discharge mortality rates.
About penKid: penkid is the very first plasma marker to monitor renal function, which is independent from comorbidities and inflammation and provides timely information about the changing kidney function in critically ill patients. sphingotest® penKid is non-inferior to the gold standard in vivo measurement of glomerular filtration rate (GFR) and penkid is elevated about 24-48 h earlier than the standard marker serum creatinine in patients developing acute kidney injury (AKI). These features enable physicians to predict, diagnose and closely monitor worsening and improving kidney function in critically ill patients. In congestive heart failure, penKid allows to adjust diuretics dosage to the situation in individual patients.
About bio-ADM: As a marker of acute vascular endothelial dysfunction, bio-ADM enables both prediction of circulatory shock, e.g. in septic patients, and prediction of residual, diuretic resistant congestion in acute heart failure patients. bio-ADM plasma levels below the cut-off value of 70 pg/ml indicate successful diuretic therapy.
A biomarker-assisted diuretics therapy in patients with congestive heart failure, by simultaneous monitoring of bio-ADM and penKid levels, promises lower re-hospitalization and mortality rates.
About ST2: ST2 is a fibrosis marker rapidly indicating cardiac remodeling. It can be used for prognosis and therapy monitoring and dosage adjustment of beta-blocker therapy in patients with congestive heart failure, which has been shown to reduce mortality and re-hospitalization.
sphingotec GmbH (Hennigsdorf, Germany) develops innovative biomarkers for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock. The company, founded by Dr. Andreas Bergmann in 2002, has also in its portfolio biomarkers which can predicts risks of obesity, breast cancer and cardiovascular diseases.
bestbion dx GmbH (Cologne, Germany) is one of the European-leading distributor of innovative diagnostic and prognostic assays with outstanding track-record in Germany and Austria. The private company was founded in 2011 by Bernd Stammel and focuses on microbiology, infectious diseases, molecular biology, cardiology and point-of-care testing.
Sympra GmbH (GPRA)
Tel: +49-(0)711 94767-0
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Federico Di Somma
Tel. +49-(0)3302 20565-20
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bestbion dx GmbH
Horbeller Straße 33
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