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Archives for June 2013

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

Vermillion’s OVA1 Receives New Statement by Society of Gynecologic Oncology

Vermillion, Inc.’s (NASDAQ: VRML), a multivariate diagnostics company focused on gynecologic cancers and women’s health, OVA1® has received a new statement on clinical validation and medical use issued by the Society of Gynecologic Oncology (SGO).

Citing peer-reviewed publications from two pivotal clinical studies of OVA1® versus standard of care, the statement also referred to OVA1 use within the context of the American Congress of Obstetricians and Gynecologists’ (ACOG) 2011 Committee Opinion, “The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer.” This guideline, updated from a previous version issued in 2002, covers the management of adnexal masses, including serum markers for ovarian cancer detection.

SGO stated: “…The test may be useful in identifying women who should be referred to a gynecologic oncologist. Recent data have suggested that the OVA1 test along with physician clinical assessment may improve detection rates of malignancies among women with pelvic masses planning surgery.” The complete statement on OVA1 clinical validation and medical use is available on SGO’s website here.
This second SGO statement on OVA1 since its FDA clearance in 2009 represents another significant step toward acceptance of OVA1 as the standard of care for pre-surgically evaluating the risk of ovarian cancer in women with adnexal masses.

The new statement does two things:

  • Refers to publications of OVA1’s two pivotal clinical studies, comprised of the original FDA validation study published in June 2011 and the OVA500 “intended use” study published in 2013. Together, this offers an extensive, peer-reviewed proof source for physicians and payers to assess OVA1’s clinical performance and comparative medical benefits versus today’s standard of care.
  • Places OVA1 use in the context of current ACOG practice guidelines, where CA125 has been used off-label for many years to predict malignancy before surgery, although with inferior performance.

Two key developments in 2013 underlined the timeliness of this updated statement by SGO. The first was the publication of the company’s second pivotal clinical study, OVA500, in the February edition of Gynecologic Oncology. OVA500 was led by Dr. Robert E. Bristow, director of Gynecologic Oncology Services at UC Irvine Healthcare in Orange, California. The second development was a study in the June edition of the journal Obstetrics and Gynecology, which made the front page of the New York Times under the headline, “Widespread Flaws Found in Ovarian Cancer Treatment.” This study, also led by Dr. Bristow, reported that most women with ovarian cancer “are treated by doctors and hospitals that see few cases of the disease and lack expertise in the complex surgery and chemotherapy that can prolong life.” Dr. Bristow said, “If we could just make sure that women get to the people who are trained to take care of them, the impact would be much greater than that of any new chemotherapy drug or biological agent.”

After reviewing the SGO statement, Dr. Hector Chapa, MD, FACOG and medical director of the Women’s Specialty Center in Dallas observed: “This new statement by SGO affirms the important role which OVA1 should play in the workup of patients with an adnexal mass, and particularly before surgery is undertaken by a surgeon uncertified in the gynecologic oncology specialty. This is important because a large number of malignancies are discovered after a surgery where the mass was thought to be benign after negative CA125 or physical examination. Now, we await an updated guideline from ACOG, replacing CA125 with the greatly improved sensitivity and negative predictive value of OVA1. After all, ACOG first mentioned excitement about OVA1 in the Gynecology Practice bulletin of March 2011, prior to publication of the two clinical studies cited by SGO. I believe the new SGO statement is a very positive advance for patients, physicians and health insurance companies alike.”

Vermillion President and CEO Thomas McLain commented: “We highly value the support SGO has provided in two statements about the benefits of OVA1 testing. For patients with ovarian cancer, Vermillion understands that timely access to a trained gynecologic oncology specialist is critical. Optimal treatment, survival and post-surgical outcomes all depend upon improvements in the detection of ovarian malignancies of all types, and as early as possible. OVA1 directly addresses the difficult challenge of identifying the more than 22,000 ovarian malignancies that are associated with 300,000 gynecologic surgeries performed every year. We look forward to supporting ACOG’s review of this new clinical data and the SGO statement. We are committed to working to improve the standard of care for all gynecologic surgery patients at risk of ovarian cancer.”

Source: PR Newswire

No Biomarkers Identified to Assess Potential Health Effects of GMOs

Many people in Europe are critical of genetically modified (GM) food, due to safety concerns. A Eurobarometer survey, published in 2010, revealed that the European public tends to be worried on a “mediate level” about GM food, with people in Austria being particularly concerned. Today, genetically modified maize is cultivated commercially, mainly in Spain and Portugal. Nonetheless, authorised GM Organisms (GMO) may enter the European market as feed for animals or in food products.

Whether such products pose any health threats to consumers, is controversial. “We have to find the best way to evaluate the issue,” says Michelle Epstein, an allergy and immunology clinician from the Medical University of Vienna, Austria. She coordinated a recently completed EU-funded project called GMSAFOOD that aimed at identifying possible biomarkers for indicating adverse health effects of GM food. Such biomarkers could be used for monitoring commercially available GM food or feed.

The European Food Safety Authority EFSA, who plays a fundamental role in assessing the risk of GM crops and derived food and feed in Europe, has included a recommendation for so-called post-market monitoring (PMM) in its Guidance for risk assessment of food and feed from genetically modified plants, published in 2011. This approach is supposed to complement the pre-market toxicological tests. “This [the PMM] is for the unexpected things”, Epstein explains. “Even if you do a lot of testing before placing a product on the market, it is not the public at large you are testing,” she tells youris.com. Some people may have immune diseases or consume certain products at very high levels.

As part of the project, the researchers conducted feeding experiments with pigs, mice, salmon and rats. They fed them with a variety of commercially available GM maize, called MON 810, and a pea containing a pest resistance gene derived from a bean. “We were using the peas because we knew it had effects”, Epstein says. Indeed, a previous study published in 2005 by Australian scientists had shown allergenic responses in mice feeding on the pea.

However, the researchers were not successful in their search for biomarkers. “We didn’t see any health effects”, Epstein comments. Moreover, when looking at the allergenic effect the peas had caused in the original study, the scientists found the same effects in the native bean, implying that the GM pea did not cause the allergic reaction. They attributed this discrepancy to a cross-reaction with a substance called pea lectin and to technical differences between testing laboratories.

The project scientists also developed a machine learning approach to identify potential GMO-associated biomarkers. Data is fed into a mathematical model, which is supposed to find parameters that may serve as biomarkers. “We proposed to the [European Commission] to set up a public repository with all of the project data,” Epstein says. This public database would also allow people from research and industry to include their own data and use the approach for identifying biomarkers for PMM.

Experts doubt the usefulness of PMM, in this case. “In my view, in contrast to the mandatory post-market environmental monitoring, monitoring GM food is questionable,” comments Joachim Schiemann, biosafety expert at the Julius Kühn-Institut, Federal Research Centre for Cultivated Plants, Germany. He considers the pre-market risk assessment of GM food as sufficient in most cases. He argues that uncertainties should be defined prior to introducing a product to the market. “The regulatory authorities have to decide how much uncertainty is acceptable,” Schiemann adds.

Other experts agree. “I am personally very reluctant to consider PMM as a useful tool for risk management of GM food or feed,” Harry Kuiper, retired scientist at Wageningen University, the Netherlands, and former head of the GMO Panel at EFSA, says. He points at various difficulties PMM may face. For example, he believes that it is hard to determine which group to target and how much of a product people actually consume.

“For the GM foods on the market today, there are simply no indications for identification of biomarkers upon exposure of humans or animals,” Kuiper also tells youris.com. “Personally, I would try to solve problems or uncertainties identified with GM food or feed during the pre-market risk assessment”, he adds. However, he believes that future GM food, which may alter the physiological or nutritional status of humans or animals, may provide opportunities for identifying biomarkers.

While she is not opposed to post-market monitoring, Helen Wallace, director of the not-for-profit organisation Genewatch UK recognises that “it is a very hard thing to do”. Instead, “we need more pre-market assessments of GM crops”, Wallace says. In her view, these should include follow-ups of studies, which suggest possible adverse health effects. She also criticises prevalent study designs and the fact that regulators have to rely on commercial studies: “These lack independence and often data isn’t made public by companies.”

Source: Youris.com

NIH Scientists Find Promising Biomarker for Predicting HPV-related Oropharynx Cancer

Researchers have found that antibodies against the human papillomavirus (HPV) may help identify individuals who are at greatly increased risk of HPV-related cancer of the oropharynx, which is a portion of the throat that contains the tonsils.

In their study, at least 1 in 3 individuals with oropharyngeal cancer had antibodies to HPV, compared to fewer than 1 in 100 individuals without cancer. When present, these antibodies were detectable many years before the onset of disease. These findings raise the possibility that a blood test might one day be used to identify patients with this type of cancer.

The results of this study, carried out by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health, in collaboration with the International Agency for Research on Cancer (IARC), were published online June 17, 2013, in the Journal of Clinical Oncology.

Historically, the majority of oropharyngeal cancers could be explained by tobacco use and alcohol consumption rather than HPV infection. However, incidence of this malignancy is increasing in many parts of the world, especially in the United States and Europe, because of increased infection with HPV type 16 (HPV16). In the United States it is estimated that more than 60 percent of current cases of oropharyngeal cancer are due to HPV16. Persistent infection with HPV16 induces cellular changes that lead to cancer.

HPV E6 is one of the viral genes that contribute to tumor formation. Previous studies of patients with HPV-related oropharynx cancer found antibodies to E6 in their blood.

“Our study shows not only that the E6 antibodies are present prior to diagnosis—but that in many cases, the antibodies are there more than a decade before the cancer was clinically detectable, an important feature of a successful screening biomarker,” said Aimee R. Kreimer, Ph.D., the lead Investigator from the Division of Cancer Epidemiology and Genetics, NCI.

Kreimer and her colleagues tested samples from participants in the European Prospective Investigation into Cancer and Nutrition Study, a long-term study of more than 500,000 healthy adults in 10 European countries. Participants gave a blood sample at the start of the study and have been followed since their initial contribution.

The researchers analyzed blood from 135 individuals who developed oropharyngeal cancer between one and 13 years later, and nearly 1,600 control individuals who did not develop cancer. The study found antibodies against the HPV16 E6 protein in 35 percent of the individuals with cancer, compared to less than 1 percent of the samples from the cancer-free individuals. The blood samples had been collected on average, six years before diagnosis, but the relationship was independent of the time between blood collection and diagnosis. Antibodies to HPV16 E6 protein were even found in blood samples collected more than 10 years before diagnosis.

The scientists also report that HPV16 E6 antibodies may be a biomarker for improved survival, consistent with previous reports. Patients in the study with oropharyngeal cancer who tested positive for HPV16 E6 antibodies prior to diagnosis were 70 percent more likely to be alive at the end of follow-up, compared to patients who tested negative.

“Although promising, these findings should be considered preliminary,” said Paul Brennan, Ph.D., the lead investigator from IARC. “If the predictive capability of the HPV16 E6 antibody holds up in other studies, we may want to consider developing a screening tool based on this result.

Source: Evaluation of Human Papillomavirus Antibodies and Risk of Subsequent Head and Neck Cancer

Source: National Cancer Institute

DaVita Labs and Myriad RBM Announce Biomarker Research Collaboration

DaVita Labs, a unit of DaVita HealthCare Partners Inc. (NYSE:DVA) and Myriad RBM, a wholly-owned subsidiary of Myriad Genetics (Nasdaq:MYGN) announced today a research collaboration to conduct protein biomarker discovery research with the goal of developing and commercializing diagnostic tests that could benefit in the treatment of dialysis patients.

DaVita and Myriad have identified potential opportunities where novel diagnostic tests utilizing blood-based protein biomarkers could improve the quality of life for patients and potentially lower overall healthcare costs. The primary area of focus will include the prediction of vascular access failure.

“This collaboration uses DaVita’s proprietary biorepository that is intended to facilitate innovative research across renal disease,” said Chris Rucker, president of DaVita Labs and DaVita Clinical Research. “Myriad recognizes the value that the biorepository can bring to research and development activities, and we look forward to collaborating with Myriad on the research and development of novel diagnostics that could transform our industry.”

“We are enthusiastic to collaborate with a company of the caliber of DaVita in the field of dialysis, one of the largest health care service markets,” said Craig Benson, president Myriad RBM. “We have extensive experience with research in kidney disease and inflammatory markers that we believe could increase the quality of care for dialysis patients.”

Specimens from the DaVita biorepository will be processed on the Myriad RBM DiscoveryMAP® platform for the quantification of more than 300 important proteins. DiscoveryMAP analyzes protein biomarkers correlated with inflammatory, metabolic and renal disease conditions that could have meaningful utility as diagnostic criteria for dialysis patients. Myriad is expected to begin processing specimens associated with this collaboration in fiscal year 2014.

Source: Myriad Genetics