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Cardiac Biomarker ST2 Proves Far Superior To Galectin-3 In A Head-to-Head Study

Critical Diagnostics recently announced that the study, “Head-to-head comparison of two myocardial fibrosis biomarkers for long-term heart failure risk stratification: ST2 vs. Galectin-3”, recently published online in JACC (the Journal of the American College of Cardiology) comparing the company’s novel cardiac biomarker ST2 to Galectin-3 (Gal-3), a biomarker from BG Medicine (NASDAQ: BGMD), found ST2 to be superior.

Gene-expression-based Biomarker Predicts Long-term Risk of Breast Cancer Recurrence

A comparison of three methods of predicting the risk of recurrence in women treated for estrogen-receptor (ER)-positive breast cancer finds that only the breast cancer index (BCI) – a biomarker based on the expression levels of seven tumor-specific genes – accurately identifies patients who continue to be at risk after five years of treatment with either tamoxifen or the aromatase inhibitor anastrozole. The study comparing the BCI with two other prognostic tests has been published online in Lancet Oncology.

Harmony Prenatal Test Now Being Offered in Mexico for Safe and Timely Risk Assessment of Chromosome Conditions During Pregnancy

Ariosa Diagnostics announced the offering of its Harmony™ Prenatal Test in Mexico through a partnership with Advance Medical on August 22, making the Latin American nation with over 2 million live births one of 46 countries around the world where the Harmony Prenatal Test can be ordered by healthcare providers. The Harmony test enables clinicians throughout Mexico to offer a non-invasive, early, reliable blood test to pregnant women. The Harmony test is both safe and cost effective, providing a personalized risk assessment for chromosome conditions such as Down syndrome.

The Harmony test has an accuracy rate above 99% for evaluation of fetal trisomy 21 risk, and a false positive rate of 0.1%, which is 50 times lower than conventional serum screening, translating into fewer referrals to unnecessary invasive diagnostic procedures such as amniocentesis that carry the inherent risk of miscarriage.

According to Dr. Dora Gilda Mayen Molina, Medical Genetic Specialist at the Hospital Angeles Lomas and Hospital Angeles Mexico, “The Harmony Prenatal Test can be performed for women with pregnancies of at least 10 weeks gestational age, and it is available for any singleton or twin pregnancy, including all those conceived by IVF.”

A recent study published in the American Journal of Obstetrics and Gynecology provided new evidence that non-invasive prenatal testing, specifically the Harmony test, is effective for screening in the general population. In the study of more than 2,000 women undergoing routine screening for fetal trisomies, the Harmony Prenatal Test accurately assessed the risk of all cases of fetal trisomy 21 and 18, with a false positive rate of 0.1 percent.

According to Dr. Thomas Musci, vice president of clinical and medical affairs for Ariosa Diagnostics, this partnership will “allow us to bring the highest quality and most clinically validated prenatal test to patients in Mexico for the betterment of prenatal medicine. We are very pleased to have partnered with Advance Medical.”

Source: PR Newswire

Big Data From Alzheimer’s Disease Whole Genome Sequencing Will Be Available to Researchers Due to Novel Global Research Database

The Alzheimer’s Association and the Brin Wojcicki Foundation announced recently that massive amounts of new data have been generated by the first “Big Data” project for Alzheimer’s disease. The data will be made freely available to researchers worldwide to quickly advance Alzheimer’s science.

Discussed recently at the Alzheimer’s Association International Conference (AAIC) 2013 in Boston, the project obtained whole genome sequences on the largest cohort of individuals related to a single disease – more than 800 people enrolled in the Alzheimer’s Disease Neuroimaging Initiative (ADNI).

The genome sequencing data – estimated to be 200 terabytes – will be housed in and available through the Global Alzheimer’s Association Interactive Network (GAAIN), a planned massive network of Alzheimer’s disease research data made available by the world’s foremost Alzheimer’s researchers from their own laboratories, and which also is being publicly announced today at AAIC 2013. GAAIN is funded by an initial $5 million dollar investment by the Alzheimer’s Association, made possible due to the generous support of donors.

“The Alzheimer’s Association is committed to creating open access to research data, and we believe GAAIN will transform how neuroscience data is shared and accessed by scientists throughout the world,” said Maria Carrillo, Ph.D., Alzheimer’s Association vice president of Medical and Scientific Relations. “By fostering a higher level of global data sharing, GAAIN will accelerate investigation and discovery in Alzheimer’s through a system comparable to a search engine like Google or Bing for relevant data.”

“With the addition of more than 800 whole genomes on ADNI subjects that can be linked to the current rich dataset, ADNI data will be even more useful to scientists who are seeking new approaches to treatment and prevention of Alzheimer’s disease,” said Robert C. Green, M.D., M.P.H., of Brigham and Women’s Hospital and Harvard Medical School, who led the ADNI sequencing project. “ADNI is a leader in open data sharing, having provided clinical, imaging and biomarker data to over 4,000 qualified scientists around the world, which has generated over 700 scientific manuscripts.

First, Massive Whole Genome Sequencing Project in Alzheimer’s Disease

Whole genome sequencing determines all six billion letters in an individual’s DNA in one comprehensive analysis. The raw data from the ADNI project is being made available to qualified scientists around the globe to mine for novel targets for risk assessment, new therapies, and much-needed insight into the causes of the fatal brain disease. The new data may enable scientists to better understand how our genes cause and are affected by bodily changes associated with Alzheimer’s disease.

ADNI enrolls people with Alzheimer’s disease, mild cognitive impairment, and normal cognition who have agreed to be studied in great detail over time. The goal is to identify and understand markers of the disease in body fluids, structural changes in the brain, and measures of memory; the hope is to improve early diagnosis and accelerate the discovery of new treatments. ADNI is led by Principal Investigator Michael W. Weiner, M.D., of the University of California San Francisco and the San Francisco VA Medical Center. Dr. Green collaborated on managing the sequencing efforts with Arthur Toga, Ph.D., of UCLA and Andrew J. Saykin, Psy.D., of Indiana University. The actual genome sequencing was performed at Illumina, Inc.

ADNI is a public-private research project led by the National Institutes of Health (NIH) with private sector support through the Foundation for NIH. Launched in 2004, ADNI’s public-private funding consortium includes pharmaceutical companies, science-related businesses, and nonprofit organizations including the Alzheimer’s Association and the Northern California Institute for Research and Education.

The Global Alzheimer’s Association Interactive Network (GAAIN)

Data-sharing has already greatly benefitted scientific disciplines such as genetics, molecular biology, and the physical sciences. Data-sharing in genetics has led to dramatic advances in understanding the risk factors underlying complex diseases. The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is a compelling example of dozens of geographically-dispersed researchers working together to share their data while making it freely available to others for analysis and publication.

“GAAIN is similar in spirit and goals to other ‘big data’ initiatives that seek to greatly improve the tools and techniques needed to access, organize, and make discoveries from huge volumes of digital data,” Carrillo said. “The advent of cloud computing makes it possible to link databases throughout the world and expand their data processing capability significantly to benefit the research community.”

Carrillo will supervise the development of GAAIN in conjunction with co-principal investigators Art Toga, Ph.D., of the Laboratory of Neuro Imaging (LONI) at the University of Southern California and Giovanni Frisoni, M.D., of the National Center for Alzheimer’s Disease Research and Care and the Instituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Fatebenefratelli Hospital, Italy. Enrique Castro-Leon, Ph.D., who will serve as a consultant, is an enterprise and data center architect for strategic partner Intel Digital Enterprise Group.

GAAIN is built on an international database framework already in use by thousands of scientists and local computational facilities in North America and Europe. The network makes research data available free-of-charge for searching, downloading, and processing across a cloud-based, grid-network infrastructure accessible anywhere through Internet access.

The key to GAAIN’s innovation is its federation of data, which is unprecedented for such a system. GAAIN leadership will invite scientists conducting qualified studies to become partners by permitting GAAIN to link directly to their databases. This will enable researchers to add continually to their data sets and keep all data in GAAIN current and dynamic. It also will enable the scientists to retain control over access to their data, which the Association believes will be important to encouraging participation.

“This is unprecedented and of the utmost importance in brain research, where sometimes thousands of examples are required to observe even the smallest change in the brain,” said Giovanni Frisoni, M.D., neurologist and deputy scientific director at the National Center for Alzheimer’s Disease Research and Care at the IRCCS. He will lead the work of GAAIN in Europe.

“Through GAAIN we envision combining massive amounts of data from multiple sources across many subjects participating in numerous studies,” said Art Toga, Ph.D., professor of neurology at UCLA and director of LONI. “This will provide more statistical power than ever before.”

Source: Alzheimer’s Association

New Blood Test Detects Colon Cancer Before it Develops

A new blood test developed in the Gastrointestinal Cancer Research Lab at Baylor Research Institute is showing very promising results for finding cancer-related microRNA in the blood before a tumor develops in the colon.

The test results, published in the latest issue of the Journal of the National Cancer Institute, are exciting and promising because this simple blood-based test examines the levels of a single microRNA – a small RNA molecule that can be readily identified in a wide variety of bodily fluids, including blood. In this seminal study the investigators studied several hundred patients with colorectal polyps and cancers and reported that measuring levels of miR-21 in the blood can accurately identify up to 92 percent of patients with colorectal cancer. Even more importantly, not only is this test good for non-invasively identifying patients who already have colorectal cancer, but it can accurately identify up to 82 percent of patients with advanced colonic polyps, which present the highest risk for developing into colorectal cancers several years later in life.

“The development of this biomarker is highly encouraging because high mortality rates associated with colorectal cancer is a consequence of late detection of this disease, underscoring the need for improved early detection, prevention, risk assessment and intervention,” said Ajay Goel, PhD, director of Epigenetics and Cancer Prevention at Baylor Research Institute. Early detection of advanced colorectal polyps and cancers is considered the most relevant target for screening strategies and the best approach to improving survival of these patients. “This blood-based test could be transformative in how we screen patients for colorectal cancer; it would save lives and could result in major savings of health care dollars,” said Michael Ramsay, MD, president of Baylor Research Institute.

While more testing needs to be done, the findings were enough to warrant an editorial in the highly regarded Journal by Heinz-Josef Lenz, MD, associate director for clinical research at the University of Southern California‟s Norris Comprehensive Cancer Center. “MiR-21 may not be ‘just another brick in the wall’ but rather may be the keystone leading to a molecularly justified, miRNA-based biomarker era in colorectal cancer,” Dr. Lenz said in the Journal.

Study: Serum miR-21 as a Diagnostic and Prognostic Biomarker in Colorectal Cancer

Source: PR Newswire