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Archives for May 2012

Raising HDL Not a Sure Route to Countering Heart Disease

A new paper published online in The Lancet challenges the assumption that raising a person’s HDL — the so-called “good cholesterol” — will necessarily lower the risk of a heart attack. The new research underscores the value of using genetic approaches to test biological hypotheses about human disease prior to developing specific drugs. A team led by researchers from the Broad Institute and Massachusetts General Hospital (MGH) explored naturally occurring genetic variations in humans to test the connection between HDL levels and heart attack. By studying the genes of roughly 170,000 individuals, the team discovered that, when examined together, the 15 HDL-raising variants they tested do not reduce the risk of heart attack.

GW Researchers Discover Biomarker for Advanced Bile Duct Fibrosis and Bile Duct Cancer

GW Researchers, Jeffrey M. Bethony, Ph.D., associate professor of Microbiology, Immunology, and Tropical Medicine, and Paul Brindley, Ph.D., professor of Microbiology, Immunology, and Tropical Medicine at GW School of Medicine and Health Sciences, along with colleagues from Khon Kaen University in Thailand have determined that plasma Interleukin-6 (IL-6) levels are an sensitive and specific biomarker for the detection of the advanced bile duct fibrosis and bile duct cancer that comes from chronic infection with the Asian Liver Fluke (Opisthorchis viverrini). The research, titled, “Elevated Plasma IL-6 Associates with Increased Risk of Advanced Fibrosis and Cholangiocarcinoma in Individuals Infected by Opisthorchis viverrini,” was recently published in the journal, PLoS Neglected Tropical Diseases.

Aushon to Launch New Multiplex Immunoassay Platform

Aushon announced its plans recently for an upcoming global launch of its new multiplex protein biomarker platform, which incorporates several engineering breakthroughs to deliver ELISA-level performance. Aushon’s ultra-precise microarray printing, novel assay design, astronomy-grade imaging and advanced analytics provide the sensitivity and reproducibility of single-plexed ELISA in a multiplexed format. The technology is designed to meet the needs of scientists who have been unable to find a multiplexing solution that consistently delivers the required performance in their studies.

Companion Diagnostics Budgets Exceed $1 Million as Companies Build Personalized Medicine into Drug Development Strategy

As the drug discovery paradigm shifts away from mass-marketed products toward targeted treatments and the life sciences industry adjusts to an increasingly payer-driven environment, precision medicine is emerging as a critical asset in the clinical development strategy. Biomarkers and companion diagnostics offer companies the ability to target a specific patient population with increased efficacy, accelerated regulatory approval and better reimbursement. Consulting firm Cutting Edge Information reports that almost 50% of drug discovery companies spend between $1 and $5 million to develop targeted therapeutic technologies that increase the effectiveness of drugs in development. Another 33% of companies invest half to a fifth as much ($500,000 to $1 million), and only a few report companion diagnostics budgets under $500,000.

Mayo Clinic Researchers Discover Biomarkers for Prostate Cancer Detection, Recurrence

Alterations to the “on-off” switches of genes occur early in the development of prostate cancer and could be used as biomarkers to detect the disease months or even years earlier than current approaches, a Mayo Clinic study has found. These biomarkers — known as DNA methylation profiles — also can predict if the cancer is going to recur and if that recurrence will remain localized to the prostate or, instead, spread to other organs. The study, published in the journal Clinical Cancer Research, is the first to capture the methylation changes that occur across the entire human genome in prostate cancer.

The discovery could someday help physicians diagnose prostate cancer earlier and make more effective treatment decisions to improve cure rates and reduce deaths. It also points to the development of new drugs that reverse the DNA methylation changes, turning the “off” switch back “on” and returning the genetic code to its normal, noncancerous state.

“Our approach is more accurate and reliable than the widely used PSA (prostate-specific antigen) test,” says senior author Krishna Donkena, Ph.D., a Mayo Clinic molecular biologist.

The PSA test detects any prostate abnormality, whether inflammation, cancer, infection or enlargement, while the DNA methylation changes are specific to prostate cancer, she says.

Though the instructions for all the cell’s activities lie within the genes, whether a particular gene is turned “off” or “on” is determined by the presence or absence of specific chemical tags or methyl groups — methylation — along the underlying DNA of cells. When this process of DNA methylation turns off the activity of tumor suppressor genes, cancer develops.

Dr. Donkena and her colleagues analyzed the methylation status of 14,495 genes from 238 prostate cancer patients. The patients included people who remained cancer-free after treatment, those who had a localized tumor recurrence and those whose cancer spread.. The researchers found that the DNA methylation changes that occurred during the earliest stages of prostate cancer development were nearly identical in all patients.

Having discovered DNA methylation patterns that could distinguish between healthy and cancerous tissue, the researchers then searched for similar biomarkers that could distinguish between patients with varying levels of recurrence risk. They found distinct methylation alterations that corresponded to whether a patient had a slow-growing tumor known as an indolent tumor, or had a more aggressive one.

If physicians can determine what type of tumor patients have, they can avoid exposing patients with indolent tumors to unnecessary treatment, and can treat those with aggressive tumors earlier and more effectively, Dr. Donkena says.

Dr. Donkena and her colleagues are working to develop a DNA methylation test that is more cost-effective and practical for use in clinical settings. Currently, the test relies on microarray or gene “chip” technology that assesses methylation status of genes across an entire genome. The researchers are trying to generate more economical custom microarray to specifically look at only the genes that predict the development of prostate cancer or recurrence.

They also hope to develop drugs that can reverse DNA methylation in prostate cancer cells. Similar drugs are already being used to treat certain forms of leukemia.

Study: Global Methylation Profiling for Risk Prediction of Prostate Cancer

Source: Mayo Clinic