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GE Healthcare Receives FDA Clearance For Q.Clear Technology

GE Healthcare, a unit of General Electric Company (NYSE: GE), recently announced that it received U.S. FDA 510(k) clearance of its Q.Clear^ technology – technology that can provide up to two times improvement in both quantitative accuracy and image quality in PET/CT imaging. This is an innovative new tool for clinicians across the entire care continuum including diagnosis, staging, treatment planning, and treatment assessment.

Ruggles Family Foundation and Mr. and Mrs. Rudy L. Ruggles, Jr. Make $1.25M Donation to J. Craig Venter Institute for New Study to Identify and Elucidate Healthy Aging Biomarkers

The J. Craig Venter Institute (JCVI), a not-for-profit genomic research organization, recently announced that the Ruggles Family Foundation and Mr. and Mrs. Rudy L. Ruggles, Jr. have made a $1.25 million donation to JCVI to identify and study biomarkers associated with healthy aging. As part of the four year grant, JCVI will collaborate with the Western Connecticut Health Network (WCHN), located in Danbury, CT.

The study, conducted by a team of scientists and clinicians from JCVI and WCHN, will focus on two groups of elderly individuals aged 65 to 85 years by correlating genetics with a variety of human genomic, gut microbiome and other “omics” profiles and integrating these data with the individuals’ health record. One group will consist of healthy individuals, and the other will have individuals with a variety of diagnosed health conditions. The team will then compare the microbiome and molecular profiles of the healthy aging group with those of the non-healthy aging group to identify biomarker candidates. The investigators hope that in the future these data can be used to develop cost-effective, clinically relevant tests.

“As traditional modes of funding for science become less and less plentiful, the need for informed and supportive philanthropic donors is more important than ever. We are grateful for the support of Rudy and Sara and the Ruggles Family Foundation as this will enable us to better understand what healthy aging looks like at the genomic level,” said J. Craig Venter, Ph.D., JCVI Founder and CEO.

“The time is right for pursuing the complex question of healthy aging given the rapid advances in analytical technologies and the expanding knowledge of the human genome and microbiome and their interactions. JCVI’s capabilities in this realm are unparalleled, and I am confident that this ground breaking study will expand materially the horizons of this area of fundamental understanding,” said Rudy Ruggles, a physicist and Adjunct Professor at JCVI, who is a healthy 74 years old and a participant in this study. He is also Chairman of the Research Advisory Council of WCHN’s Biomedical Research Institute.

According to a United Nations report, in 1950 there were 205 million people worldwide aged 60 or older. By 2000 there were 606 million aged 60 or older, and they project that by 2050 this figure will reach nearly 2 billion people who are 60 or older. Understanding the elderly patient and figuring out modes of intervention to better prevent and treat disease associated with aging will continue to be an important area of research.

In addition to more comprehensively studied human genetic factors, other areas of human health and biology that influence and define healthy aging in humans are emerging. For example, a healthy microbiome (the full complement of microbes that live on and in the human body) interacts with the human immune system establishing protective activities when necessary. Low-grade chronic inflammation in humans is a risk factor for the development of more serious diseases that reduce life spans. New tools and technologies developed since the first sequencing of the human and other genomes are now allowing researchers to explore the human body in more detail than ever before, including identifying biological signatures (biomarkers) indicative and even predictive of healthy aging.

According to JCVI President Karen Nelson, Ph.D., “JCVI’s extensive knowledge in human genomics, comparative genomics and the human microbiome, coupled with the clinical expertise of WCHN, should result in new insights into healthy aging. We are excited to add this new study to our repertoire of ongoing human microbiome studies as it will enhance our knowledge in this important area of research.”

For more information on how to support the genomics research programs at JCVI, contact Katie Collins, 858-200-1847.

Source: The J. Craig Venter Institute

JAMA Pediatrics Study Highlights Cancer Risk Associated with CT Scans

Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1 Test, a rapid, protein biomarker-based assay for identifying patients at low risk for appendicitis, today announced its support of key findings from a large retrospective study that was published earlier this week in the peer-reviewed medical journal JAMA Pediatrics. The study concluded, among other things, that the risk of radiation-induced solid cancers was highest for patients undergoing CT scans of the abdomen/pelvis and that abdominal/pelvic scans saw the most dramatic increase in use over the study period, especially among older children. Possible appendicitis was cited as a leading cause of abdominal/pelvic CT usage.

Importantly, the authors of the study concluded that reducing unnecessary CT scans in favor of other imaging or non-imaging approaches (if proven through research to be as effective), combined with effective radiation dose-reduction strategies, could dramatically reduce the number of radiation-induced cancers.

Steve Lundy, President and CEO of Venaxis, stated, “The findings of this large observational study are aligned with our focus – developing a blood-based APPY1 Test to aid physicians in identifying patients at low risk for acute appendicitis. We applaud the authors of the study for reporting these findings and for highlighting the urgent need for research to determine when the use of CT scans leads to improved health outcomes and when other imaging and non-imaging diagnostic techniques could be as effective. The APPY1 Test is designed to provide rapid, objective results and has demonstrated high negative predictive value for appendicitis in clinical studies. Venaxis’ goal with the APPY1 Test is to provide physicians with an additional tool that may allow for more conservative patient management, including reducing the number of CT scans.”

The JAMA Pediatrics study measured the rate of CT scan use (from 1996 to 2010) and the dose of ionizing radiation (for CT scans performed between 2001 and 2011) in children younger than 15 years of age, and estimated the lifetime attributable risks of certain cancers. The projected lifetime attributable risk of developing solid cancers was higher for patients who underwent CT scans of the abdomen/pelvis or spine than for patients who underwent other types of CT scans. The risk was highest for younger patients and for girls, with a radiation-induced solid cancer projected to result from every 300 to 390 abdomen/pelvis scans.

Study: The Use of Computed Tomography in Pediatrics and the Associated Radiation Exposure and Estimated Cancer Risk

Source: Venaxis

Low Levels of Serum Bilirubin Spell Higher Lung Cancer Risk for Male Smokers

Elevated levels of bilirubin in the blood get attention in the clinic because they often indicate that something has gone wrong with the liver. Now researchers have found that male smokers with low levels of the yellow-tinged chemical are at higher risk for lung cancer and dying from the disease.

A team led by researchers at The University of Texas MD Anderson Cancer Center reported its findings in a late-breaking abstract at the AACR Annual Meeting 2013 in Washington, D.C.

“Our study indicates male smokers with low levels of bilirubin are a high-risk group that can be targeted with smoking cessation help, low-dose spiral CT screening of their lungs and other preventive measures,” said senior author Xifeng Wu, M.D., Ph.D., professor and chair of MD Anderson’s Department of Epidemiology and the Betty B. Marcus Chair in Cancer Prevention.

Lung cancer usually is diagnosed at a late stage, when tumors are inoperable and treatments largely ineffective. The overall five-year survival rate is 15 percent, but it falls to 5 percent for stage 3 lung cancer patients and 1 percent for those with stage 4 disease.

Spiral CT scans catch cancer early, biomarker could reduce false positives

The National Lung Screening Trial found that low-dose spiral computed tomography screening reduces mortality among heavy smokers by 20 percent. However, 95 percent of growths found by spiral CT are false positives, a barrier to large-scale screening.

“Validated biomarkers are urgently needed to improve risk prediction for lung cancer and to reduce false positives, shifting the balance toward more effective and efficient CT screening for cancer detection,” Wu said.

The researchers started with an objective analysis of levels of metabolites — substances produced during metabolism. Bilirubin is produced during the breakdown of old blood cells.

They analyzed 60 samples divided into three groups known as “trios” — normal controls, early stage and late stage non-small cell lung cancer patients. The top three metabolites were validated in two more groups of 50 and 123 trios.

When bilirubin emerged as the most significant metabolite, another validation study was done in a prospective cohort of 435,985 people with 208,233 men in Taiwan.

Men were divided into four groups according to their serum bilirubin levels. Lower bilirubin level was associated with significantly higher rates of both lung cancer incidence and mortality.

In the Taiwanese cohort, the incidence rate per 10,000 person-years in men was 7.02 for those in the lowest bilirubin quartile (.68 mg/dL or less), compared to 3.73 in the highest quartile of bilirubin level (1.12 mg/dL or more). The mortality rate per 10,000 person-years was 4.84 for the lowest level compared with 2.46 in the highest bilirubin quartile.

Next step: Establish a risk prediction model in heavy smokers

Bilirubin makes sense as a protective agent because of its anti-oxidant, anti-inflammatory and anti-proliferative effects. “It’s plausible that bilirubin protects against lung cancer by scavenging free radicals and carcinogens associated with smoking,” said study presenter Fanmao Zhang, a doctoral candidate in epidemiology.

Indeed, a Belgian study showed that bilirubin in the high normal range lowered cancer mortality in men. A study in the United Kingdom showed higher bilirubin levels in the normal range were associated with lower risks of chronic obstructive pulmonary disease, lung cancer and all-cause mortality. Neither of those studies stratified their analysis of bilirubin by smoking status.

“We expected that bilirubin might be protective, but our finding that bilirubin levels affect only smokers was somewhat of a surprise,” Wu said. “Our discovery that low levels increase lung cancer risk is unique.”

Smokers in the two middle cohorts of bilirubin levels also had higher lung cancer risk than those in the highest quartile. As an objective risk index for lung cancer and all-cause mortality, low levels of bilirubin should send an urgent message to quit smoking, said Chi Pang Wen, M.D., Ph.D., co-lead author from National Health Research Institutes, Taiwan.

The next step, Wu said, is to evaluate the predictive value of serum bilirubin in heavy smokers and to establish a risk prediction model that incorporates bilirubin and other biomarkers with clinical and epidemiological data to improve the efficiency of lung cancer risk prediction.

Source: EurekAlert!

Penn Medicine’s New Center for Personalized Diagnostics Unlocks Cancer’s Secrets

Just like a massive iceberg jutting out of the ocean, many of cancer’s genetic underpinnings remain hidden under the surface, impossible to predict or map from above. The foreboding shadows and shapes that appear on CT scans and MRIs – and even in the field that doctors see when they zoom in to look at cancer cells under a high-powered microscope – are just the tip of the iceberg.

Penn Medicine’s new Center for Personalized Diagnostics, a joint initiative of the department of Pathology and Laboratory Medicine in the Perelman School of Medicine and the Abramson Cancer Center, is diving deeper into each patient’s tumor with next generation DNA sequencing. These specialized tests can refine patient diagnoses with greater precision than standard imaging tests and blood work, all with an aim to broaden treatment options and improve their efficacy.

“We’re using the most advanced diagnostic methods to unlock cancer’s secrets,” says David B. Roth, MD, PhD, chairman of the department of Pathology and Laboratory Medicine. “A tumor’s genomic profile is the most critical piece of information for an oncologist to have when they’re deciding what therapy to recommend. The results of tests in the Center for Personalized Diagnostics reveal a genetic blueprint of each patient’s tumor that is as discrete and singular as a fingerprint.”

The Center for Personalized Diagnostics unites top experts in genomic analysis, bioinformatics, and cancer genetics – who use the most sensitive data analysis tools available to identify the rarest of mutations – with oncologists who treat patients and design clinical trials to test new therapies. Together, their efforts will provide cancer patients with cutting-edge diagnostic and therapeutic options.

The first group of patients who are undergoing testing through the CPD includes those with blood cancers and solid tumors of the brain, melanoma, and lung. Throughout 2013, the tests will be expanded for a wider range of cancer patients. Results are available within two weeks – twice as fast as most commercially available testing panels. All new and relapsed Abramson Cancer Center patients will receive this testing – conducted via simple blood tests and/or biopsy of tumor tissue or bone marrow – as part of their evaluation and diagnostic process. Interpretation of results is communicated one-on-one to patients and their caregivers by physicians and genetic counselors.

In contrast to the CPD’s offerings, individual genetic tests – which now proliferate in the marketplace, even for healthy people who may be interested in going on a spelunking expedition through their DNA – are time consuming and expensive to conduct, and they often yield information which is not clinically actionable. When these tests are offered for cancer patients, patients are often left with only a veritable alphabet soup detailing genetic information, with few plans for how to use those findings to conquer their cancer.

Since the CPD began operating in early 2013, however, tests in 80 percent of patients revealed genetic mutations that may be used to alter their treatment course or clarify their prognosis. The results are playing a role in:

  • Matching patients with existing therapies designed to target mutations previously associated only with different cancers. For instance, some lung cancer patients exhibit mutations of the BRAF gene, which is targeted by drug Vemurafenib, initially developed and approved for melanoma. Testing in the Center for Personalized Diagnostics is helping clinicians make new connections that will expand the indications for existing drugs.
  • Helping physicians determine which treatments a patient will respond to, or how well they will tolerate a particular treatment. Patients with the blood cancer acute myelogenous leukemia who express a mutation known as DNMT3A, for instance, are known to respond to higher doses of the drug daunorubicin. Learning this type of information prior to beginning treatment can help oncologists select and dose drugs in a way that will reduce side effects and boost patients’ quality of life during treatment – and increase their chance of completing their prescribed regimen.
  • Identifying patients who are likely to have a poor prognosis if treated with first-line therapies, which allows clinicians to set up a cascade of alternative therapies or, in the case of some blood cancer patients, expedite the search for a matching bone marrow donor.
  • Detecting resistance mutations that could slow or halt patients’ response to targeted drugs, which allows for custom-designed combination therapies to attack tumors through multiple pathways.

The Center’s research agenda operates in parallel with its clinical care mission. Each patient’s test results will add to an enormous repository of genomic mutation profiles that, combined with the ability to follow patients over time, will help clinical researchers identify new markers and mutation profiles to better predict the course of an individual patient’s treatment response and suggest new targets for therapy. As new mutations are detected and novel treatment options are identified, the gene testing panels will be modified and expanded, creating an evolving, real-time mutation profiling option.

“We see 11,500 newly diagnosed patients each year in the Abramson Cancer, and hundreds of others who seek our help when their cancers have not responded, or have returned, after receiving standard therapies elsewhere,” said Chi Van Dang, MD, PhD, director of the Abramson Cancer Center. “A key part of our mission is to provide each of these patients these tests as soon as possible, so that we can quickly tailor a treatment regimen that provides them the greatest chance of a cure.”

Source: Penn Medicine