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Newly Public, Arrayit Sets Sights on Molecular Dx to 'Pick Up Where Research Left Off'

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Arrayit will now increasingly focus on building an offering in the molecular diagnostics business by seeking partnerships with external experts and bringing talent in-house, a company official said last week.

President and Co-founder Mark Schena told BioArray News that the company's current business goal is to "transition Arrayit from a life-sciences research-oriented company to a life-sciences health-care company," and that developing diagnostic applications on its arrays are part of that effort.

Marketing an array platform, reagents, scanners, and analysis software, Arrayit bills itself as a one-stop shop for researchers looking to outfit a lab. The company, which had been incorporated in Nevada, remained privately held as Telechem International until March, when it merged with Integrated Media Holdings, a digital media company, in a $23.1 million deal that allowed it to go public (see BAN 3/24/2009).

As part of the merger, Arrayit adopted its current name and reincorporated itself in Delaware. Arrayit also begun trading as a public company on the Over-the-Counter Bulletin Board under the ticker symbol "ARYC."

CEO Rene Schena, who is married to Mark Schena, told BioArray News that Arrayit decided to go public the way it did to "raise awareness of arrays for clinical applications and also to raise capital to move into this larger market.

"There is a very large opportunity for Arrayit to participate in moving arrays from research into clinical diagnostic use," she said. "That is one of our main focuses as a public company."

According to Mark Schena, Arrayit's strategy for moving into molecular diagnostics rests on developing alliances with "high-profile disease institutes." Last month, the company, based in Sunnyvale, Calif., announced a partnership with the Parkinson's Institute and Clinical Center, also located in Sunnyvale.

Under the terms of the deal, researchers in the neurogenetics division at Parkinson's, led by Birgitt Schüle, will use Arrayit's Human Genome H25K array to look for biomarkers linked to Parkinson's disease. The H25K contains contains 26,304 long oligonucleotides specific for 25,509 fully annotated human genes, according to Arrayit (see BAN 4/14/2009). Schüle did not return an e-mail or phone calls seeking comment.

"We are working closely with Parkinson's," said Mark Schena. "They are providing the clinical component and we are providing the technology platform." The ambition of the duo is to "develop a comprehensive roadmap for Parkinson's disease," he said.

He added that Arrayit will offer the association access to all of its technology to "address all key molecular challenges in Parkinson's disease; to develop diagnostics for genotyping Parkinson's patients; to examine mRNA using expression profiling; and to perform protein profiling.

"In a comprehensive sense, what we are doing for diagnostics is leveraging all the core technology we have been developing for the last 12 years," Schena said. "We have spent a lot of time developing surfaces, surface chemistry, methods, clean rooms, and the rest. All of these work well for entering diagnostics market."

In addition to working with the Parkinson's Institute, Arrayit said last month that it will work with Stephen Walker, a geneticist at Wake Forest University Medical Center in North Carolina, in an autism-related screening project. The company, though, declined to elaborate on the collaboration with Walker.

According to Schena, Arrayit also has diagnostic interests in oncologym, especially ovarian, prostate, and breast cancers. "A lot of diseases such as ovarian cancer are misunderstood because if ovarian and other cancers are caught early the prognosis is good," Schena said. "An array is a very sensitive diagnostic screening test. Being able to look early in progression of disease provides better diagnosis than entering late.

"The bottom line is that we think that preventitive medicine will help reduce cost of healthcare going forward," he added.

While Schena did not discuss a date for when Arrayit hopes to debut its first diagnostic, he did say that the company envisions taking its tests through the US Food and Drug Administration's 510(k) clearance process. "We are certainly moving in direction of having approved tests," he said.

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'Large Growth'

Company spokesperson Paul Haje told BioArray News that the growth potential of the molecular diagnostics market has piqued Arrayit's interest in it. "There is growth in that sector that picks up where research left off," Haje said. "We are seeing about a 19-percent industry growth rate for array-based diagnostics, and we are looking at figures potentially as big as $6 billion [in the entire molecular diagnostics market] annually by 2012. The market is trending towards a platform that is flexible and can look at different biomolecules on a chip," Haje added.

He said that Arrayit had the expertise and IP to do both. "This is very empowering," he said. "We think that we can exceed the numbers that are out there right now for the projection of this industry."

As part of Arrayit's transition, Rene Schena said that the company will be hiring clinicians and experts in its particular diagnostic areas of focus.

Arrayit is also considering creating a susidiary company for particular tests. "There will be very large growth happening at our company over the next few years," she said. According to Schena, one advantage Arrayit has is its wide menu of array-related products.

"Over the past 12 years, we have developed our own version of everything you need to use array technology," Schena said. She added that the company has recently begun offering labs a "complete platform."

Schena cited the Ministry of Health of the Republic of Belarus as a client that has created an entire array lab using Arrayit's products. Arrayit inked a distribution pact with Belmedtechnika, an equipment provider based in Minsk, earlier this year (see BAN 1/16/2009).