Industry news that matters to you.  Learn more

PatientPartner Improves Adherence in First Independent IRB-Approved Clinical Trial of a Mobile Game Application in Diabetes Patients

Breakthrough clinical trial results for “PatientPartner,” a new mobile game application designed by scientists and researchers at CyberDoctor, document for the first time the effectiveness of a story-driven game in changing health behavior and biomarkers. Results of the clinical trial demonstrating increased adherence among patients with diabetes were announced last month at the Health 2.0 Conference, October 2nd, in Santa Clara, CA. The unique, universal, non-disease specific approach allows PatientPartner to be effective in improving adherence in all patient populations.

Decades of Improving Cholesterol Levels Abruptly Ended in 2008, PLOS ONE Study Finds

Decades of declines in LDL cholesterol blood levels, a key marker of death risk from heart disease, abruptly ended in 2008, and may have stalled since, according to a multi-year, national study published recently in PLOS ONE.

The study, by researchers at Quest Diagnostics (NYSE: DGX), examined low-density lipoprotein, or LDL, blood-serum cholesterol test results of nearly 105 million individual adult Americans of both genders in all 50 states and the District of Columbia from 2001-2011. The study is the largest of LDL cholesterol levels in an American population, and the first large-scale analysis to include data from recent years 2009-2011.

“Our study suggests that significant improvements in heart disease risk through declines in LDL cholesterol blood levels over the past several decades came to an unexpected and sudden end in 2008,” said investigator Robert Superko, M.D., medical director, cardiovascular disease, Quest Diagnostics. “The unprecedented scale of our data set should spur additional research to identify the cause or causes in order to prevent a possible reversal in years of gains in cardiovascular health in the U.S. population.”

The study found a net 13% decline in the annual mean LDL cholesterol level of the study population over the 11-year period. Between 2001 and 2008, the average age-adjusted mean LDL levels declined from about 120 mg/dL to 104.7 mg/dL, but plateaued at that level for the remainder of the study period. LDL levels of 100 mg/dL or lower are considered optimal by the American Heart Association. By 2011, about 46% of patients had achieved LDL levels lower than 100 mg/dL, while 6% of patients had LDL levels in the high-risk category of 160 mg/dL or higher.

Blood cholesterol levels are the primary biomarker for cardiovascular disease, which accounts for one in every three deaths in America. High levels of LDL (“bad”) cholesterol can cause arterial clogging, increasing the risk of stroke and heart disease. Treatments typically include lifestyle modification and therapy with lipid-lowering medications such as statins. Every 10 mg/dL decline in LDL is associated with an approximately 5-13% decline in major vascular disease events, such as strokes and mortality.

Prior research, including results of three National Health and Nutrition Examination Surveys (NHANES) of nearly 40,000 patients for the years 1988 to 2010, demonstrated that LDL levels have declined in the United States while the use of lipid-lowering medications has increased.

The Quest Diagnostics Health Trends study, “Blood Cholesterol Trends 2001-2011 in the United States: Analysis of 105 Million Patient Records,” was published online May 10, 2013 in the peer-reviewed, open-access journal PLOS ONE.

Theories for the LDL Plateau

The observational study in PLOS ONE did not identify a cause for the trends in LDL cholesterol blood levels, although investigators suggested several hypotheses.

“It is possible that the economic recession that began at about the same time LDL values plateaued in our study played a role. Patients dealing with financial constraints may have been less inclined to visit their physician or use their medications at full dose, limiting access to and effectiveness of treatment. Individuals may also have experienced changes in stress levels, diet, sleep and other behaviors, due to the poor economy, which in turn may have adversely impacted lipids,” said Harvey W. Kaufman, M.D., senior medical director, Quest Diagnostics.

The investigators also theorized that statins users in the study may have reached the maximum therapeutic-threshold level or that increases in obesity prevalence or other co-morbid factors during the 11 years of the study period contributed to the LDL plateau.

“These speculative, but plausible theories deserve additional research so the cause of the trend seen in our data can be addressed and hopefully reversed,” said Dr. Kaufman.

Gender Differences

The investigators also found differences in LDL cholesterol declines by gender. The decline in annual age-adjusted mean LDL cholesterol blood levels was slightly greater among men than women, with an average 13.4% decline for men compared to a decline of 12.5% for women.

“Though the differences are not statistically significant, they may reflect meaningful differences in the prescription rate and effectiveness of lipid-lowering interventions, including statins and lifestyles, between genders,” wrote investigators in the study. They also theorize that the differences may be due in part to “under-appreciation of heart disease risk in women,” given female-specific AHA guidelines and risk-classification algorithms for women were introduced only in 1999 and 2007, respectively.

Greater Vigilance Required

“Like other Quest Diagnostics Health Trends reports, our goal is to provide insights, based on diagnostic data, to enhance public health and patient management and, fundamentally, create a healthier world,” said Dr. Kaufman.

“We believe this new study will encourage additional population research to inform public health efforts. But we also believe the study should prompt individual patients to be vigilant about practicing healthy behaviors and lipid-lowering treatment plans. Our hope is physicians and patients will have more productive conversations about the importance of LDL control to cardiovascular health as a result of this study,” said Dr. Kaufman.

The study’s strengths include its size, national representation, longitudinal analysis and incorporation of data up through 2011. It also includes its separation of data into distinct years, as opposed to other large-scale studies, such as NHANES, which group findings into multiple years. The study represents patients under medical care and not the general American population and did not include results of clinical records, such as medical history and medications, to assess contributing factors to the results. The study examined test results of patients tested by Quest Diagnostics. Data was de-identified prior to analysis and the Western Institutional Review Board exempted the study from review.

Study: Blood Cholesterol Trends 2001–2011 in the United States: Analysis of 105 Million Patient Records

Source: Quest Diagnostics

Exhaled Breath Carries a ‘Breathprint’ Unique to Each Individual

Stable, specific ‘breathprints’ unique to an individual exist and may have applications as diagnostic tools in personalized medicine, according to research published April 3 in the open access journal PLOS ONE by Renato Zenobi and colleagues from the Swiss Federal Institute of Technology (ETH) and the University Hospital Zürich, Switzerland.

The researchers studied the chemicals present in exhaled breath from eleven participants, collected at different times of the day over an 11-day period. They found significant differences in the chemicals present in each person’s samples, and discovered differences between samples taken at different times of day from the same person. Despite these variations, their results identified a core ‘breathprint’ unique to each individual that was highly specific and could be linked to its owner. The factors that contribute to this unique breathprint are still unknown.

The authors suggest that attributes like diet, health conditions or exposure to other chemicals may contribute to these individual signatures of breath. According to the study, these results suggest that breath analysis may eventually become a valuable source of clinical information, similar to the analysis of other fluids such as plasma or urine.

Study: Human Breath Analysis May Support the Existence of Individual Metabolic Phenotypes

Source: EurekAlert!

Genophen Taps NextBio Clinical to Incorporate Genomic Data into Disease Risk Software

NextBio recently announced that it has formed a partnership with Genophen, a Stanford University spinout, which will focus on generating personalized disease prevention and wellness plans for patients based on a combination of genomic, clinical, environmental, and behavioral data.

Specifically, Genophen is partnering with NextBio so that it can use the NextBio Clinical platform to analyze genetic variants from whole genome sequence data and combine these with information on things like diet, family history, and exercise to create bespoke disease prevention plans for patients.

Genophen’s President and CEO Hossein Fakhrai-Rad told BioInform that the company tapped NextBio’s platform because it offered access to a curated database of genomic variants that are associated with various disease conditions, and because it expands Genophen’s own internally built repository. The arrangement also lets Genophen focus its efforts on disease risk assessment rather than spend time going through the literature and linking variants and diseases, he said.

Founded in 2008 at the Stanford Genome Technology Center, Genophen has developed a software system dubbed ‘the Genophen platform’ that uses a series of proprietary algorithms to assess patients’ risk of developing complex or multi-factorial diseases such as type II diabetes based on genetic, clinical, environmental, and behavioral information. The platform then provides personalized recommendations to help patients minimize their risk. The platform also prioritizes factors that increase patients’ risk based on their health profiles, and calculates how lifestyle changes could help reduce risk.

Genophen plans to launch its platform publicly in a few weeks, and it will include new features such as a new user interface, Fakhrai-Rad said. He added that in the last year his company has been putting the platform through its paces with a select group of physicians and patients via a pilot project and a currently ongoing beta test program.

The company has also partnered with Illumina’s CLIA laboratory to handle the whole-genome sequencing aspect of its business, Fakhrai-Rad said. Also, it is finalizing arrangements with a second CLIA lab that will offer genotyping services, which are less comprehensive than NGS but much cheaper, Fakhrai-Rad said.

In addition, Fakhrai-Rad stressed that the company will not offer a direct-to-consumer service, but will work in concert with physicians and genetic counselors who will be responsible for discussing a recommended course of action with patients and helping them make decisions about next steps.

For NextBio, the partnership with Genophen reflects a growing demand for its tools from healthcare providers who are looking to make it easier to use whole-genome and targeted sequencing data, NextBio CEO Saeid Akhtari told BioInform.

Historically, the company’s products have been patronized by customers in the pharmaceutical and biotechnology industries involved in drug research and development. However, since the launch of NextBio Clinical last April (BI 4/27/2012), it has begun to receive business from clients in the clinical market including cancer centers, hospitals, and diagnostic companies, Akhtari said.

For instance, last June the company announced that the Cancer Care Institute had licensed its product portfolio — which also includes the NextBio Research software — to analyze oncology patient data for research studies and to select appropriate treatments for patients based on their molecular profiles (BI 6/29/2012).

Earlier this year, Emory University’s Winship Cancer Institute and the Aflac Cancer Center of Children’s Healthcare of Atlanta tapped NextBio Clinical to support their partnership, which is focused on identifying biomarkers that can predict brain cancer metastasis in children in order to help clinicians determine which patients should receive radiation therapy (BI 1/25/2013).

And NextBio expects that the demand for its clinical software to continue to grow and even surpass demand from the pharma/biotech market over the next few years as more clinicians and patients continue to avail themselves of sequencing and molecular profiling technologies, Akhtari said.

The software is also holding its own, Akhtari said, against competing products such as KnomeClinic, a software suite launched by Knome for interpreting and annotating human genomes(BI 6/15/2012).

NextBio believes customers prefer its offering, according to Akhtari, because it provides access to analytic capabilities on private cloud infrastructure so that customers don’t have to purchase their own hardware; offers comprehensive curated content; and comes with an adaptive learning knowledgebase that uses newly incorporated information from patients to improve correlations between variants and disease. The company also updates its software and database content regularly in response to customers’ requests, he said.

Akhtari said that NextBio has potential deals currently going through an “approval process” with other companies besides Genophen, but declined to disclose who those new clients are.

Source: Genophen

Recon 2 Modeling May Help Tailor Treatments for Patients with Metabolic Diseases, Cancer

An international team of researchers, including an investigator with the Virginia Bioinformatics Institute at Virginia Tech, has produced what may be the most comprehensive computer model of human metabolism yet developed.

The discovery, detailed Sunday (March 3, 2013) in the journal Nature Biotechnology, advances understanding of human metabolism in health and disease. Called Recon 2, the model builds and improves upon earlier-generation metabolic reconstruction systems and may be useful for finding biomarkers of metabolic diseases, such as glycogen storage disorder, as well as identifying cancer drug targets and predicting unwanted drug side effects.

A variety of models and approaches have co-existed with the common goal of reconstructing human metabolism, but this one connects the dots, adding metabolic information from a variety of databases including content from the DrugBank database, which details the reactions caused by experimental and FDA-approved drugs to individual enzymes and reactions typical of the metabolic system.

“This is important because we are finally mapping the links between the human genome and metabolism,” said Pedro Mendes, a computational systems biologist and leader of the Biochemical Networks Modeling Group at the Virginia Bioinformatics Institute. “The results provide a framework that will lead to a better understanding of how an individual’s lifestyle, such as diet, or a particular drug they may require, is likely to affect them according to their specific genetic characteristics. The model takes us an important step closer to personalized medicine, where treatments will be tailored according to the patient’s genetic and metabolic information.”

Scientists from Blacksburg, Va.; Manchester, Cambridge, Edinburgh, Reykjavik, San Diego, Berlin and others mapped 65 human cell types and more than 1,000 enzymes that are known drug targets.

With this new map, researchers will be able to deepen their understanding of the role human metabolism plays in health and disease.

Study: A community-driven global reconstruction of human metabolism

Source: EurekAlert!