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With Two IVDs Nearing Approval, Spain s Nascent Array Sector Bears First Fruits

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Spanish start-up Owl Genomics last week introduced Hepatochip, its first microarray-based in vitro diagnostic for the diagnosis and prognosis of non-alcoholic steatohepatitis (NASH).

A company official said the IVD, which analyzes the co-expression patterns of 85 genes linked to NASH, is about to undergo a validation study by Gregorio Marañón Hospital in Madrid, and added that the Hepatochip is already commercially available.

Schering, the German biopharmaceuticals company, is interested in the Hepatochip, Owl CEO Miryam Asuncion told BioArray News via e-mail this week. The firm will be providing financial support to the hospital during the clinical validation study and Asuncion said the study will proceed when Schering gives it the green light.

"We are able to give diagnosis right now, so from this point of view, the Hepatochip is already in the market," Asuncion said. The chip itself will not become available until it receives its CE Mark approval sometime after the validation at Marañón, but that the company technically could run samples.from clinicians located worldwide and make a diagnosis in its own labs.

"It is the policy of Owl Genomics to [provide] our service on demand [to clinicians]," Asuncion said. "So, if there is a potential customer who will be interested in offering this diagnosis alone [without purchasing the chip] in the US for example, Owl Genomics is open to make an agreement."

According to Asuncion, the clinical validation study at Marañón Hospital is not only valuable for its role in preparing the Hepatochip for regulatory approval, but also for introducing the chip to its target customers and for attracting potential collaborators.

The validation study "is a way to introduce this product in the Spanish market," said Asuncion. "We are waiting for Schering to give the final OK to this collaboration to begin with. Once started, we expect it will last around three months," she said.

From Owl's perspective, Schering would be a valuable partner to boost the company's international profile. The German company has an established relationship with Marañón Hospital, and is interested in up-and-coming therapies for IBD.

NASH is a hepatic disease similar to alcoholic hepatitis that normally strikes patients that are obese and who suffer from type-2 diabetes. Asuncion said that there are no other hepatochips on the market and that the potential size of the market is "huge."

"Two hundred million people have diabetes in world. When you add in those who suffer from obesity and cardiovascular disease - the market is huge," she said.

"The prevalence of [obesity and type-2 diabetes] is increasing and the prevalence of NASH is also expected to increase," the Owl said in a statement. "Therefore, this disease has become an emerging public issue in United States as well as in other developed countries."

Asuncion said her company is currently working on ways to improve the existing test. For example, she said the company wants to develop a simple blood test for diagnosing and rendering prognoses for the disease, and to get away from using biopsy samples, which can be more expensive, invasive, and time consuming than an array-based test.

"Our main focus right now is to develop an easy diagnosis blood test for NASH, which could avoid biopsies," Asuncion said.

Meanwhile at Progenika

Owl Genomics, based in the Basque region of Northern Spain, is a 3-year-old private company that was enticed to the area after rigorous courting from the local Basque government, which sets its own economic policies independent of Madrid. Also, by launching the Hepatochip, Owl become the second company in three months to have come out of the local biocluster to launch an IVD.

In late January, Progenika, located in the same industrial park as Owl Genomics, announced that it had created an IVD for diagnosing and helping clinicians treat inflammatory bowel disease, called the IBD Chip.

According to Antonio Martinez, Progenika's technical director who led the company in developing the IBD Chip for commercial use, the product is an array-based test that screens for 80 or so SNPs related to IBD to either assess a patient's susceptibility to diseases such as Crohn's disease and ulcerative colitis, or to help physicians diagnose the disease and monitor patients' response to treatment.

Martinez said that because the genetic basis of IBD is so complex, conventional genetic analysis would be too expensive for most clinicians.

In May, Progenika will begin a three-month clinical validation study of the chip with 400 Spanish patients. Martinez said the company will begin seeking European approval for the test by September.

Progenika has already received a CE Mark approval in September 2004 for its Lipochip, an array-based IVD for hypercholesterolemia. Another Progenika product, the Bloodchip, a microarray for genotyping different blood groups, is currently being validated in 3,000 samples in several large European blood banks, Martinez said.

— JP

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