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Expecting a CE Mark for BloodChip, Progenika Will Grow US Presence and Submit Dx to FDA

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Progenika, a Spanish biotech firm that has developed a series of array-based diagnostics, is moving forward with plans to market a chip for blood typing in Europe while at the same time positioning itself to pursue US Food and Drug Administration clearance for several of its products, including BloodChip, according to a company spokesperson.
 
Progenika’s Antonio Martinez told BioArray News this week that the company has submitted its BloodChip to European regulatory bodies and that it expects to receive a CE Marking for the tool this fall. BloodChip has been on the market as a research-use-only assay since 2006, but Progenika recently completed a validation of 1,000 samples on the chip, enabling it to potentially meet European Union directives.
 
“We have been running a validation in 1,000 samples and this validation has been submitted in Europe for CE Mark,” said Martinez. “We expect to have a CE mark in October, but now the chip is available for research use,” he added.
 
BloodChip is a DNA genotyping chip that allows users, such as blood banks, to multiplex a variety of typing tests into one assay, potentially saving them time and money. Specifically, 116 SNPs are genotyped to stratify samples into 10 different blood groups — ABO, RhCE, RhD, Kell, MNS, Kidd, Diego, Dombrock, Colton, and Duffy.
 
Progenika believes that its chip will be most beneficial for such patients as pregnant women at risk of maternal alloimmunization, those undergoing multiple transfusions, or D negative patients that might incorrectly receive blood serotyped as Dneg RhD variants.
 
The chip was born out of Progenika’s involvement in Bloodgen, an EU-wide consortium funded through its Fifth Framework Program that paired the company with bloodbanks in the UK, Sweden, Germany, the Czech Republic, and Spain.
 
Progenika currently has five theme chips either on the market or in development, including a LipoChip for the diagnosis of familial hypocholesterolemia, PharmaChip for genotyping SNPs involved in the regulation of drug metabolism, IBDChip for diagnosing inflammatory bowel disease, BloodChip for genotyping blood groups, and a FibroChip, which enables users to determine whether a patient has fibromyalgia or chronic fatigue syndrome. In every case, Progenika’s path is the same: achieve a CE Marking in Europe, and lay the foundation for an eventual 510(k) market clearance in the US.
 
Two of Progenika’s arrays, the LipoChip and the IBDChip, have already received CE Marking in 2004 and 2006, respectively (see BAN 12/5/2006). Martinez said that Progenika expects to submit the PharmaChip and FibroChip for CE Marking this fall, so that by December all of the chips in its pipeline will be ready for clinical use in Europe.
 
Boston and the FDA
 
Progenika currently operates out of its headquarters in Derio in northern Spain. The firm is building a larger, 27,000-square-foot facility to house its future operations, expected to open next year, which will also be located in Derio. The company also opened a UK office in 2005 and followed suit this winter by establishing a US presence in Boston.
 
According to Martinez, Progenika will handle all of its European operations as well as manufacturing out of the Derio office, while the US office plans to function as a Clinical Laboratory Improvement Amendments lab.
 
All of the chips will be manufactured in Derio, he said. “That is the reason why we need more space. The American office will be a lab, but we will still manufacture the chips here.” The objective of the Boston office is “from one side to get the CLIA certification and to offer products that already have CE Marking in Europe, but also to receive FDA approval to sell a product, not just a service,” he said.
 

“The objective of the Boston office is ... to receive FDA approval to sell a product, not just a service.”

Martinez said that initially Progenika plans to submit four of its products to the FDA: PharmaChip, LipoChip, Bloodchip, and FibroChip. IBDChip will have to be submitted at a later date because of the complex nature of the disease and the need for Progenika to validate the array in the US.
 
“At the beginning our interest was monogenic diseases, where if you had a mutation, you had a disease, like in LipoChip. The same was with BloodChip,” Martinez explained. “Now we are interested in complex diseases. An example of that is IBD where we use an algorithm to predict the probability of developing a specific phenotype. That is why IBDChip will be a second phase in our submission plans,” he added.
 
As Progenika moves ahead with its plans for FDA submission, set to commence next year, it will also raise its headcount in Boston. Currently Progenika has a two-man shop in Boston, but Martinez said there will be 12 people by year end and 22 by the end of 2008.
 
Meanwhile, the company is also building sales and marketing forces in Derio. The firm, which currently employs 70 people in Spain, has leaned heavily on R&D hires over the past seven years, and Martinez said that Progenika may grow to 100 people in 2008. “New people will be devoted to commercialization of products and manufacturing,” he said. “Most people now here are PhD molecular biologists.”

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