Quantcast

Industry news that matters to you.  Learn more

Archives for August 2013

Hyperion Medical Introduces the Sudoscan

Hyperion Medical is recently announced the availability of the FDA approved SudoScan device to the medical community. The SudoScan device is a new solution for Sudorimetry, measuring of the sweat gland function as a biomarker for autonomic nervous system (ANS) function.

Spinal Fluid Biomarkers of AD and Brain Functional Network Integrity on Imaging Studies

Both Aß and tau pathology appear to be associated with default mode network integrity before clinical onset of Alzheimer disease (AD), according to a study by Liang Wang, M.D., and colleagues at Washington University in St. Louis, Missouri.

Accumulation of Aß and tau proteins, the pathologic hallmarks of AD, starts years before clinical onset. Pathophysiological abnormalities in the preclinical phase of AD may be detected using cerebrospinal fluid (CSF) or neuroimaging biomarkers, according to the study background.

A total of 207 older adults with normal cognition participated in the cross-sectional group study. Researchers examined the relationship between default mode network integrity and cerebrospinal fluid biomarkers of Alzheimer disease pathology in cognitively normal older individuals using resting-state functional connectivity magnetic resonance imaging.

According to the study results, decreased cerebrospinal fluid Aß42 and increased cerebrospinal fluid phosphorylated tau181 were independently associated with reduced default mode network integrity, with the most prominent decreases in functional connectivity observed between the posterior cingulate and medial temporal regions (regions of the brain associated with memory). Observed reductions in functional connectivity were unattributable to age or structural atrophy in the posterior cingulate and medial temporal areas.

Study: Cerebrospinal Fluid Aβ42, Phosphorylated Tau181, and Resting-State Functional Connectivity [JAMA Neurology]

Source: EurekAlert!

Researchers Identify Biomarkers for Possible Blood Test to Predict Suicide Risk

Indiana University School of Medicine researchers have found a series of RNA biomarkers in blood that may help identify who is at risk for committing suicide.

In a study reported Aug. 20 in the advance online edition of the Nature Publishing Group journal Molecular Psychiatry, the researchers said the biomarkers were found at significantly higher levels in the blood of both bipolar disorder patients with thoughts of suicide as well in a group of people who had committed suicide.

Principal investigator Alexander B. Niculescu III, M.D., Ph.D., associate professor of psychiatry and medical neuroscience at the IU School of Medicine and attending psychiatrist and research and development investigator at the Richard L. Roudebush Veterans Affairs Medical Center in Indianapolis, said he believes the results provide a first “proof of principle” for a test that could provide an early warning of somebody being at higher risk for an impulsive suicide act.

“Suicide is a big problem in psychiatry. It’s a big problem in the civilian realm, it’s a big problem in the military realm and there are no objective markers,” said Dr. Niculescu, director of the Laboratory of Neurophenomics at the Institute of Psychiatric Research at the IU School of Medicine.

“There are people who will not reveal they are having suicidal thoughts when you ask them, who then commit it and there’s nothing you can do about it. We need better ways to identify, intervene and prevent these tragic cases,” he said.

Over a three-year period, Niculescu and his colleagues followed a large group of patients diagnosed with bipolar disorder, completing interviews and taking blood samples every three to six months. The researchers conducted a variety of analyses of the blood of a subset of participants who reported a dramatic shift from no suicidal thoughts to strong suicidal ideation. They identified differences in gene expression between the “low” and “high” states of suicidal thoughts and subjected those findings to a system of genetic and genomic analysis called Convergent Functional Genomics that identified and prioritized the best markers by cross-validation with other lines of evidence.

The researchers found that the marker SAT1 and a series of other markers provided the strongest biological “signal” associated with suicidal thoughts.

Next, to validate their findings, working with the local coroner’s office, they analyzed blood samples from suicide victims and found that some of same top markers were significantly elevated.

Finally, the researchers analyzed blood test results from two additional groups of patients and found that high blood levels of the biomarkers were correlated with future suicide-related hospitalizations, as well as hospitalizations that had occurred before the blood tests.

“This suggests that these markers reflect more than just a current state of high risk, but could be trait markers that correlate with long term risk,” said Dr. Niculescu.

Although confident in the biomarkers validity, Dr. Niculescu noted that a limitation is that the research subjects were all male.
“There could be gender differences,” he said. “We would also like to conduct more extensive, normative studies, in the population at large.”

In addition to extending the research to females to see if the same or other markers come into play, Dr. Niculescu and colleagues plan to conduct research among other groups, such as persons who have less impulsive, more deliberate and planned subtypes of suicide.

Nonetheless, Dr. Niculescu said, “These seem to be good markers for suicidal behavior in males who have bipolar mood disorders or males in the general population who commit impulsive violent suicide. In the future we want to study and assemble clinical and socio-demographic risk factors, along with our blood tests, to increase our ability to predict risk.

“Suicide is complex: in addition to psychiatric and addiction issues that make people more vulnerable, there are existential issues related to lack of satisfaction with one’s life, lack of hope for the future, not feeling needed, and cultural factors that make suicide seem like an option.”

He said he hopes such biomarkers, along with other tools, including neuropsychological tests and socio-demographic checklists currently in development by his group, ultimately can help identify people who are at risk, leading to pre-emptive intervention, counseling, and saved lives.

“Over a million people each year world-wide die from suicide and this is a preventable tragedy”.

Study: Discovery and validation of blood biomarkers for suicidality [Molecular Psychiatry]

Source: Indiana University School of Medicine

Study Reveals Much-needed Strategy to Protect Against Deadly Liver Fibrosis

Chronic liver disease is a leading cause of death in the United States, in part because it often causes the formation of harmful scar tissue—a process known as fibrosis. A study published by Cell Press August 15 in the journal Immunity reveals the central role the immune molecule interleukin 33 (IL-33) plays in the formation of liver fibrosis. The findings suggest that drugs targeting this molecule could serve as a new treatment strategy to protect against liver fibrosis.

“Currently, the therapeutic options for liver fibrosis are limited and not curative,” says senior study author Stefan Wirtz of Friedrich-Alexander University Erlangen-Nuremberg. “We identified novel immunological factors that contribute to the development of liver fibrosis, opening up new avenues for the treatment of this serious condition.”

Liver fibrosis refers to the accumulation of harmful deposits of extracellular matrix (ECM) proteins, and it can eventually lead to organ failure. Past studies have suggested that this kind of damage is associated with abnormal immune responses in the liver, but very little was known about the molecules and cells that contribute to fibrosis.

In the new study, Wirtz and his team found that the amount of IL-33 in the blood was higher than normal in patients with liver disease. Following up on this observation, they discovered that injection of IL-33 into mice caused ECM proteins to build up in the liver, whereas mice that were genetically modified to lack IL-33 were largely protected from fibrosis. The researchers went on to identify the immune networks underlying IL-33’s harmful effects and discovered that this molecule activates immune cells called type 2 innate lymphoid cells (ILC2), which had never before been linked to liver disease.

“Our findings reveal IL-33 as a novel biomarker that could potentially lead to early detection of fibrosis in patients, which may be extremely valuable for preventing further damage to the liver,” Wirtz says. “Moreover, the study shows that drugs targeting IL-33 or ILC2 responses could be a promising strategy to protect against fibrosis and chronic liver disease.”

Study: Interleukin-33-Dependent Innate Lymphoid Cells Mediate Hepatic Fibrosis [Immunity]

Source: EurekAlert!

Precision Therapeutics Announces Unparalleled Results That Show Recurrent Ovarian Cancer Patients Live 65% Longer in Breakthrough Prospective Clinical Trial

Precision Therapeutics, Inc., a life science company dedicated to developing personalized medicine products for individualized cancer care, recently announced that compelling results have been accepted for publication in Gynecologic Oncology, a leading, peer-reviewed clinical oncology journal. The accepted study is currently located on the Gynecologic Oncology website.

The prospective study, conducted in conjunction with Yale University School of Medicine and over 30 additional cancer centers nationwide, showed that recurrent ovarian cancer patients treated with a chemotherapy identified as sensitive by the ChemoFx® drug response assay lived 14-months longer, a (65%) improvement in overall survival, as compared to patients treated by non-sensitive chemotherapies classified by ChemoFx.

Additionally, ChemoFx was able to identify at least one sensitive chemotherapy agent for more than half of the recurrent ovarian cancer patients studied, approximately doubling current statistics suggesting that only 20 to 30 percent of cancer patients with recurrent ovarian cancer benefit when treated with chemotherapy chosen empirically.

262 evaluable patients were treated with one of 15 study-designated standard chemotherapy treatments selected by the treating oncologist, who was not informed of the ChemoFx results. When blinded to the results of the assay, physicians treated 25% of patients with a sensitive chemotherapy, while more than half (52%) of the study participants showed at least one assay-sensitive chemotherapy from which they could have benefited had the physician been assay-informed. The data implies that if ChemoFx results were utilized by physicians prior to treatment, the number of patients receiving sensitive treatments, and thereby experiencing improved survival outcomes, could have more than doubled. The study clearly shows that patients treated with sensitive chemotherapies identified by ChemoFx outperformed patients treated with alternate chemotherapies.

Median progression free survival also improved by 50% for patients treated with sensitive chemotherapies as identified by ChemoFx vs. those treated with non-sensitive agents (hazard ratio [HR] = 0.67, p = 0.009). The association with assay response was consistent in both platinum-sensitive and platinum-resistant tumors (HR: 0.71 vs. 0.66) and was independent of other covariates in multivariate analysis (HR = 0.66, p = 0.020). A statistically significant 14-month improvement in median overall survival (37.5 months for patients treated with sensitive agents vs. 23.9 months for who were not, HR = 0.61, p = 0.010) was also reported.

“This clinical study is a landmark for the treatment of ovarian cancer because it is the first prospective data that definitively shows that a personalized diagnostic test can make a significant clinical impact by improving overall survival by 65% in women with this devastating cancer,” said Thomas J. Rutherford MD, PhD, Professor of ObGyn and Reproductive Sciences and Section Chief, Gynecologic Oncology at the Yale School of Medicine, and lead investigator in the study.

ChemoFx results show a dramatic difference when compared to recent recurrent ovarian cancer studies that produced limited improvements in progression free survival (2-3 months), and very few if any improvement in overall survival (2 months)2-14

This breakthrough study shows that through the use of the ChemoFx assay, treating physicians can treat with effective chemotherapy drugs which may help extend the life of patients afflicted with this disease. No recent test, therapy or innovation compares in terms of impact on patient’s lives and it is reason for new hope for the treatment of this disease.

“The clinical significance of this study is that ChemoFx may have predictive abilities, enabling a physician to choose the most effective pharmaceutical treatment from among the available options for ovarian cancer,” said Robert Holloway, MD, Medical Director of Florida Hospital Gynecologic Oncology.

Study: A prospective study evaluating the clinical relevance of a chemoresponse assay for treatment of patients with persistent or recurrent ovarian cancer [Gynecologic Oncology]

Source: Business Wire