Medical Device Daily Staff Writer

A recent study published in the journal JAMA Pediatrics shows 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.

One med-tech company is focused on obtaining FDA clearance for an assay that could help reduce the number of CT scans in children who are thought to suffer from appendicitis, if given the green light. Venaxis (Castle Rock, Colorado) reported that it has developed the APPY1 Test, a rapid, protein biomarker-based assay for identifying patients at low risk for appendicitis.

"The study provides another data source - if you will - to show that this issue of CT scans on children, and the health issues associated with it aren't going away anytime soon," Steve Lundy, president/CEO of Venaxis told Medical Device Daily. "I think the results just call out the need for a simple non invasive blood test to help these physicians guide their treatment course so they can more confidently exclude patients from CT scans as many of these CT scans aren't really needed."

The JAMA Pediatrics study, which was done independently of the Venaxis 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.

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.

"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," Lundy said. "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."

But before there is a shift in the use of CT scans in appendicitis to blood-based tests, the attitudes surrounding CT must change. To do that, Lundy said that there needs to be an effective test approved by the FDA with strong clinical data.

"There needs to be a test that's validated as being clinically efficacious," Lundy said. "Our hope is that by getting our test through the FDA with performance data that is compelling, is that physicians would indeed change the behavior."

APPY1 is a rapid, protein biomarker-based assay for appendicitis. This appendicitis test has projected high sensitivity and negative predictive value and is being developed to aid in the identification of patients at low risk for acute appendicitis, allowing for more conservative patient management. The APPY1 Test is being developed initially for pediatric, adolescent and young adult patients with abdominal pain, as this population is at the highest risk for appendicitis and has the highest risk of long-term health effects associated with CT imaging.

In January, the company said that it began enrolling patients into its pivotal clinical study in the U.S.

Lundy told MDD that the company was in the middle of the pivotal trial with about 28 hospitals enrolled in the study.

"We designed the trial with input from the FDA," Lundy said. "We met with FDA a couple of times before we started the trial. We feel like we've done our homework and now it's just a matter of executing the trial and getting the top line results that would be needed."

Earlier this year, the company also said that it had fulfilled the requirements for CE marking in Europe for APPY1, the company's blood-based appendicitis test. Initial commercialization in Europe is planned to commence in 1Q13 in key territories, including the UK, Italy, France, Germany and Benelux countries.

Omar Ford; 404-262-5546;

omar.ford@ahcmedia.com

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