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Progenika Inks Companion-Dx Deal with AMT, Service Pact with ARUP Labs

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By Justin Petrone

Spanish biotech firm Progenika Biopharma recently announced two separate deals to make its array technology and expertise available to partners.

In the first deal, announced last week, Progenika together with Amsterdam Molecular Therapeutics aims to develop and market an array-based test to identify patients who have lipoprotein lipase deficiency and may be candidates for AMT's Glybera gene therapy.

In the second deal, announced two weeks ago, Progenika will provide blood group genotyping reference laboratory services to ARUP Laboratories. ARUP this month will begin offering the service to determine patient red blood cell antigen profiles when serology has logistic and functional limitations.

CEO Antonio Martinez told BioArray News this week that Progenika plans to engage in more companion diagnostic deals going forward as it develops and commercializes its own tests for familial hypercholesterolemia, drug metabolism, blood group identification, and other applications, including fibromyalgia, inflammatory bowel disease, multiple sclerosis, rheumatoid arthritis, and osteoarthritis.

"We have developed a very robust platform for DNA genotyping with very high sensitivity and specificity, so we are interested in applying our technology to these kind of companion diagnostics products, mainly in our main areas of expertise like cardiovascular disease," Martinez said this week.

According to a statement from AMT, the firm will collaborate with Progenika to develop an LPLchip, to diagnose patients with complete and partial LPLD who may benefit from treatment with Glybera. The firm said that Glybera can produce long-term health benefits for LPLD patients and can reduce acute pancreatitits, a complication of the disease. AMT said it plans to file the therapy for marketing in Europe by the end of this year.

Martinez said that the development of an LPLD chip would "complement [Progenika's] portfolio of products in the cardiovascular field." He said that the LPLD chip will identify mutations in the LPL gene responsible for lipoprotein lipase deficiency.

According to Martinez, after the LPLD chip has been developed, Progenika will market it from its European headquarters in Derio, Spain, and in the US, where it has a Clinical Laboratory Improvement Acts-compliant lab in Cambridge, Mass.

At first, AMT patient samples will be processed in Progenika's facilities, Martinez said. As the number increases or according to reimbursement and regulation policies, platforms may be installed in other locations to process the test, he said.

Unlike the deal with AMT, the agreement with Salt Lake City-based ARUP Labs calls for Progenika to provide blood group genotyping reference-laboratory services based on the technology, rather than develop a new companion diagnostic.

Martinez said that Progenika’s BloodChip blood group genotyping microarray, which is designed to detect over 100 genetic variants in the nine blood group systems that are most relevant to transfusion safety, will be made available to ARUP via Progenika's Cambridge lab.

According to the firm, Progenika’s blood group genotyping supports disease management for patients whose condition requires chronic transfusions, such as chronic lymphocytic leukemia, autoimmune hemolytic anemia, Hodgkin’s lymphoma, sickle cell disease, and thalassemia. The firm began offering the BloodChip in this US this year (see BAN 1/13/2009).

In addition to the in-development LPLD chip and the BloodChip, Progenika sells a LipoChip designed to diagnose familial hypercholesterolemia, and a PharmaChip, which is meant to monitor a patient's ability to metabolize over 50 drugs, giving a phenotype for phase I and phase II enzymes, drug transporters, neurotransmitters receptors, and other drug targets.

Additionally, Progenika has developed an IBDChip that enables researchers to analyze around 100 relevant mutations in inflammatory bowel disease patients and can predict the clinical evolution of IBD, the risk of developing IBD-related complications, and the likelihood of responding to certain drugs, according to Martinez.

So far, services on LipoChip and BloodChip are only being offered in the US. Martinez said that Progenika does not intend to introduce new arrays in the US next year. "We are focusing all our efforts in blood-group genotyping and familial hypercholesterolemia as these products are demonstrating that they have a strong potential in the US," he said.

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