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Venaxis on Track to File Appendicitis Test with FDA, Launch in Europe

NEW YORK (GenomeWeb News) – As Venaxis prepares a submission to the US Food and Drug Administration for its appendicitis diagnostic test and a full European launch, the company announced this week the completion of the first futility analysis of the test.

As a result, an independent body has recommended a continuation of Venaxis' pivotal clinical trial for the test, called the APPY1 Test. The trial will include a second futility analysis.

The futility analysis is analysis of the validity, integrity, and clinical and scientific relevance of the ongoing pivotal study for APPY1 that was performed by an external data and safety monitoring board. On a conference call today, Venaxis President and CEO Steve Lundy said that the first futility analysis was performed on an initial 500 patients who completed the study, and following the analysis, the board recommended the continuance of the pivotal study.

With the recommendation, Venaxis can now focus on the enrollment of additional evaluable patients "as quickly and efficiently as possible," Lundy said. Currently, about 830 patients who have completed or are enrolled in the study are awaiting their two-week follow-up after being released from their hospitals with an initial diagnosis of negative for appendicitis.

The company plans to enroll a total of 2,000 patients for the clinical trial.

Lundy said that Venaxis anticipates completing patient enrollment and the release of top-line data by the end of 2013, after which it will file with FDA for de novo 510(k) clearance of APPY1 in the first quarter of 2014.

APPY1 is a blood-based lateral flow test to help physicians determine whether suspected acute appendicitis patients are at low risk for the ailment, and therefore may not be candidates for additional imaging tests. It measures three biomarkers: C-reactive protein, white blood cell count, and the MRP8/14 protein.

The power of APPY1's negative predictive ability, company officials said, is that it can lower healthcare costs. Venaxis is currently conducting market development tests in Europe aimed at quantifying cost savings resulting from APPY1, as well as clinically validating the test.

Chief Commercial Officer Don Hurd said on the conference call that healthcare cost savings would be achieved from a reduction in overall imaging, both in ultrasound and the number of CT scans performed on patients who have tested negative on APPY1. Also, the number of patients requiring a surgical consultation prior to imaging is expected to be reduced, as is the time spent in emergency rooms by patients being prepped prior for imaging or for observational purposes.

While the test in its current iteration is intended for the identification of patients who are at low risk of appendicitis, Lundy told GenomeWeb Daily News that Venaxis may pursue development of a next-generation test that would target patients with a high risk.

Venaxis has identified additional biomarkers that could serve such a purpose, but due to the lateral flow format used on the current test, they could not be included on APPY1. However, these markers could be included in a future test based on one of the newer multiplex immunoassay systems that are commercially available, Lundy said.

The priority for now, though, is on getting APPY1 cleared by FDA. The company plans to build a sales force upon the receipt of positive top-line data from the clinical trial, Hurd said. Lundy told GWDN that Venaxis will initially hire about 10 sales people and will market APPY1 through a direct sales model in the US.

Venaxis will focus on the top 2,000 to 2,500 hospitals, but "I think we're going to make a real focus on community hospitals, because our analysis indicates that the use of CT scans is much higher in community hospitals than in academic medical centers where they tend to have more access to ultrasounds," Lundy said.

In May the company raised $14.4 million in a public offering, and it had about $20 million in cash as of the end of June, which should carry it through the FDA clearance process and into commercialization of APPY1, Lundy said on the conference call.

The test was CE marked in January and market development for the test in Europe "remains an active and ongoing process," Hurd said, adding that Venaxis is on track for a full launch of the test there in the fourth quarter.

Venaxis has been "aligning" itself with distributors in regions that it calculates account for 75 percent of the in vitro diagnostic market in Europe. In agreements reached with companies, Venaxis and its partners will validate the market size of each territory, identify key opinion leader hospital sites for conducting clinical and economic outcome studies, identify other hospitals as "high priority sales targets," Hurd said.

"The goal is two-fold," he said. "First and foremost, it is to fully understand the impact of the APPY1 on the clinical workflows and economic outcomes in each territory and to generate a robust and objective body of evidence that fully demonstrates the value of the APPY1 test for all types of hospitals."

The second objective is to build customer demand for the test ahead of the full European launch.

Venaxis has four market development agreements in place with European distributors and are selecting partners in additional key territories, Hurd said. The company previously announced deals with Moss covering Italy, Savas Medikal for Turkey, and Emelca Bioscience covering Belgium, Luxembourg, and the Netherlands.

Hurd said today that Venaxis has also signed a deal with Spring Medical covering Switzerland and Austria. Additionally, the firm has met with potential partners in the UK, Germany, and France and is in the final stages of picking companies to help in developing those markets. Those agreements are expected to be inked by the end of the third quarter.

While a price for APPY1 has not yet been finalized, Lundy said that the range is anticipated to be $75 to $80 in the US, with the price in the European Union about 25 to 30 percent lower.

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