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Stock Sale to Support Arrayit's Move to New Headquarters, Expanded Operations, and CLIA Lab Launch

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After raising $1 million last month in a non-brokered private placement, Arrayit is moving into new headquarters in Sunnyvale, CA, where it intends to open CLIA and ISO-certified facilities by early next year.

The new facility — which Arrayit CEO Rene Schena told BioArray News is about twice the size of the firm's previous location also in Sunnvale — will allow the company to begin offering clinical array-based testing through a CLIA lab within about six months. This could include the company's OvaDx test for ovarian cancer, as well as other, unnamed assays in the company's diagnostics pipeline, President and Chief Science Officer Mark Schena said.

"We'll be building our class 100 clean rooms over the next few weeks and moving in by the beginning of January," Rene Schena added. "And we will also be expanding on our staff, adding scientists and some support people."

Arrayit Founder and Chief Technology Officer Todd Martinsky said that the firm has been working on a range of microarray projects that could potentially be offered in a clinical context now that the company will be opening a CLIA lab. "We are really feeling now that our platform is clinical-ready," he said.

"With the technology in general there is a lot happening in protein and peptide microarrays and we have some new microarrays for testing for both food and environmental allergies for both humans and for companion animals. … We also have our gene expression microarrays — really lots that we will [now] be able to offer in the CLIA setting, so we are very excited about that," he said.

Beyond OvaDx, Arrayit is also developing assays for Parkinson’s disease, prostate cancer, Plavix metabolism testing, and male fertility testing, according to the company's website.

As of 2011, Arrayit had split its microarray technology supply business from its diagnostic development efforts, creating a separate company — originally called Arrayit Diagnostics, now Avant Diagnostics — to commercialize OvaDx and submit the test for FDA clearance as an IVD.

The new CLIA plans are a twist on the firm's earlier strategy, but according to company officials, the intention to commercialize OvaDx through Avant Diagnostics as an FDA-cleared test still remains "on track," despite the possibility that the company could offer it in the meantime as an LDT.

According to the Rene Schena, Arrayit's $1 million private placement in October was oversubscribed, and the company plans to use the money to support its move and associated expansion, as well as its efforts to secure CLIA and ISO certifications for the new facility.

As the firm settles into its new headquarters, it is ironing out details of a new project with the US Department of Agriculture in the food safety area, the company told BioArray News, for which commercialization details are still being decided.

"We are in contract negotiations with the USDA to commercialize a food safety chip … which will cover 50 percent of the produce consumed in the United States during the winter months," Mark Schena explained.

The company also announced a number of new customer orders in recent weeks, including microarray and reagent sales to the University of California, Illumina, and Google (BioArray News 10/24/2013).

Arrayit declined to provide further details on these orders, or how these specific customers plan to use the tools they have purchased.

Arrayit also announced a sale to the Department of Veterans Affairs in October of its Colorimetric Protein Microarray Platform I, which Martinsky did provide some detail on— explaining that the Veteran Affairs Hospital plans to use the platform for reverse-phase protein array experiments.

"Our platform is increasingly being used [for RPPA] to replace western blot," Martinsky said. "So we are really happy to see orders like that coming in."

Finally, the company also said this week that it has signed an agreement with Amazon.com to begin selling its life science products through an Amazon storefront; a move which the firm said would allow greater customer access.

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