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US, Finland, Idaho Tech, AstraZeneca, EpiStem, Rosetta Genomics, Columbia University, LabCorp, Roche

US, Finnish Researchers Identify New Genetic Variants for Type 2 Diabetes
Researchers in the US and Finland have identified at least four new genetic variants associated with increased risk of type 2 diabetes.
The study, being hailed as the most comprehensive look at genetic risk factors for type 2 diabetes, was a collaboration between researchers from the University of Michigan, the National Human Genome Research Institute, the University of Southern California, the University of North Carolina, and Finland’s National Health Institute.
Researchers used a genome-wide association study involving 32,554 people from Finland, Poland, Sweden, the UK, and the US. They identified four new diabetes-associated variations and confirmed six previously identified genetic variants associated with increased diabetes risk.
According to a release from the NHGRI late last month, the newly identified diabetes-associated variations lie in or near the IGF2BP2, CDKAL1, CDKN2A and CDKN2B genes, and Chromosome 11.
The findings have been published in the online edition of Science.
“This achievement represents a major milestone in our battle against diabetes. It will accelerate efforts to understand the genetic risk factors for this disease, as well as explore how these genetic factors interact with each other and with lifestyle factors,” said NIH Director Elias Zerhouni. “Such research is opening the door to the era of personalized medicine. Our current one-size-fits-all approach will soon give way to more individualized strategies based on each person’s unique genetic make-up.”
Diabetes affects nearly 21 million in the US, and the disease incidence has dramatically increased in the past three decades. The disease can cause heart disease, stroke, adult blindness, kidney failure, and amputations not related to trauma.
According to the researchers, “their predictions of disease risk need to be interpreted with caution because the diabetes group in their sample was ‘enriched’ with people who had affected siblings and because the healthy group excluded people who had impaired glucose tolerance or impaired fasting glucose.”

Idaho Tech Wins $8.76M NIAID Grant to Continue Developing PCR-Based Flu Dx
Idaho Technology has received an $8.76 million grant from the National Institutes of Health to continue developing a diagnostic panel for respiratory viruses, including the H5N1 avian flu, the company said last week.
Idaho Tech, based in Salt Lake City, said its FilmArray panel will help healthcare workers survey and diagnose influenza strains with pandemic potential as well as “common respiratory viruses.”
The FilmArray, which is still in its prototype phase, is a nucleic acid-based PCR diagnostic platform that can detect DNA and RNA, said Jill Powlick, an Idaho Technology attorney. 
Powlick told Pharmacogenomics Reporter sister publication GenomeWeb Daily News that the device is “a self-contained instrument that does sample prep and amplification of up to 120 targets in a single sealed pouch.”
The funding, which is to be spread over five years, was granted by the National Institute for Allergy and Infectious Disease under a Cooperative Research Partnership.
The project also includes collaborators at the Primary Children’s Hospital of Salt Lake City and the Naval Medical Research Unit 3 in Cairo, Egypt, the company said.

AstraZeneca Will Use EpiStem's 'Plucked Hair' Technology to Study Biomarkers in Cancer Rx Research
EpiStem, a UK company focused on developing epithelial stem cells from human hair, said this week it has partnered with AstraZeneca to conduct feasibility studies for a biomarker program that may help the drug developer in preclinical and clinical cancer drug studies.
EpiStem’s so-called “plucked hair” approach is a biomarker program based on a “link between the stem cells in the small intestine and the hair follicle,” the company said. The biomarker now has been developed into “a non-invasive tool to measure drug effects on adult epithelial stem cells and tissues.”
The technology analyzes changes in gene expression that may be found in hairs plucked from human cancer patients in various phases of treatment. These changes can offer researchers information such as the “measure of drug exposure, toxicity, dose/schedule, and patient selection,” the company said.
Because it is non-invasive, the company said, this methodology may be particularly useful in assessing drugs in preclinical development, “thereby assisting go/no go decisions” about drug development and reducing risk and expense of a drug failing in the clinical trial phase.
Brent Vose, AstraZeneca’s vice president of oncology therapies, said minimally invasive biomarkers are “an important step” for the company’s oncology drug programs, and said the firm has been “impressed by the plucked hair biomarker technology.”
Jeff Moore, managing director of EpiStem’s novel technologies program, said the US Food and Drug Administration “has made it clear that they want new drugs to have biomarkers that show the direct impact of the drug.”
Moore also said that “at this stage of our development” the company will not make predictions about the program’s commercial value.

RosettaGenomicsSignsColumbiaUniversity CLIA Lab to Validate microRNA-Based CUP Dx
Rosetta Genomics this week said that a Columbia University Medical Center lab will validate its microRNA-based diagnostics program for Cancer of Unknown Primary.
The agreement calls for the company to provide the school’s Clinical Laboratory Improvement Amendments-certified lab with its protocol for diagnosing the primary origin of metastatic cancers, which will then be tested and validated using blinded samples provided by the medical center.
The alliance is Rosetta Genomics' first agreement that aims to clinically validate one of its cancer diagnostics. The company is developing several diagnostics at its R&D facilities in Israel and the United States.
The CUP diagnostic, currently in the final stages of development, is designed to help clinicians identify the origin of tumors that have metastasized throughout the body.

LabCorp to Sell Roche's AmpliPrep/COBAS TaqMan HIV-1 Dx
Laboratory Corporation of America will be the first commercial laboratory in the US to sell Roche Diagnostics' AmpliPrep/COBAS TaqMan HIV-1 test, the company said this week.
The US Food & Drug Administration approved the real-time PCR test May 11.
The product quantifies the amount of HIV in the blood to enable doctors to establish a baseline HIV infection level before starting treatment. They could also use the test to monitor patients' responses during treatment.
In a statement, LabCorp said the test’s ability to fully automate sample preparation, amplification, and detection in a standardized process “will eliminate a number of manual steps and enhance the total quality process.”
Financial terms of the agreement were not disclosed.

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