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Iris Restructures Personalized Medicine Division

NEW YORK (GenomeWeb News) – Iris International announced after the close of the market on Wednesday the restructuring of its personalized medicine division, including the downsizing and absorption of Arista Molecular into its Molecular Diagnostics business.

Arista, formerly called AlliedPath, was purchased by Iris last year. The consolidation of the business into Molecular Diagnostics is expected to be completed by Oct. 1.

In addition, non-proprietary testing services — including flow cytometry, FISH, cytology services, and its molecular pathology menu — will be discontinued, Iris said. Arista will retain all licenses and high-complexity CLIA laboratory capabilities, and limited personnel will also be retained to perform laboratory-developed tests based on Iris' nucleic acid detection immunoassay platform called NADiA.

The restructuring is anticipated to result in fourth-quarter savings of between $1.4 million and $1.6 million as a result of reduced expenses and costs associated with the restructuring. Iris also expects to write off associated assets of about $6 million. On an annualized basis, expense reduction is expected in the range of $4.5 million to $5 million.

Iris said that the 510(k) submission to the US Food and Drug Administration for the NADiA ProsVue test for prostate cancer is "progressing."

"While disappointed that Arista did not develop as we had originally anticipated, we will retain all capabilities to perform NADiA-based tests including NADiA ProsVue upon FDA clearance," Cesar Garcia, president, chairman, and CEO of Iris, said in a statement.

"We are developing a comprehensive commercialization strategy, which includes potential distribution and licensing collaborations, as well as a targeted direct sales effort for ProsVue," he added. "In addition we continue to make strides in developing future tests based on NADiA and other proprietary technology platforms that may include laboratory-developed tests under the CLIA regulations."

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