Progenika Biopharma this week said that it has received a CE mark for its LPLchip, enabling it to sell the array to physicians in the European Union to help diagnose patients with complete or partial lipoprotein lipase deficiency.
The LPLchip is one of several diagnostic arrays that Bilbao, Spain-based Progenika has developed. The low-density chip allows users to detect more than 120 mutations in the LPL gene, supports the diagnosis of LPLD, and can be used to identify patients who may benefit from gene therapy for LPLD, according to the firm.
Indeed, the LPLchip was designed with Amsterdam Molecular Therapeutics, a Dutch firm that has developed a new genetic treatment for LPLD called Glybera. According to Progenika, AMT filed Glybera for marketing authorization with the European Medicines Agency earlier this year, and a decision on the approval is expected by the middle of 2011. Progenika began working with AMT last year (BAN 11/3/2009).
Additionally, Progenika said the LPLchip can be used to identify patients at elevated risk for familial combined hyperlipidemia and premature atherosclerosis due to the presence of non-compound heterozygous LPL mutations.
Familial lipoprotein lipase deficiency disrupts the normal breakdown of fats in the body, characterized by inflammation of the pancreas, abdominal pain, enlargement of the liver and spleen, and small yellow skin lesions called eruptive xanthomas, according to the US National Institutes of Health.
The NIH estimates that the condition affects about 1 person per million worldwide, though it states that it is "much more common" in some areas of Quebec.
AMT is currently following up study on two clinical studies conducted in Europe and Canada, and is conducting a third clinical study in Canada. In these three studies, Glybera has led to a "sizeable decrease in the incidence of pancreatitis," Progenika said.
In addition to the LPLchip, Progenika also sells its Lipochip for the diagnosis of familial hypercholesterolaemia, and its Bloodchip for ensuring compatibility in blood transfusions. Both of those arrays are available for research use only in the US, where the company maintains an office in Cambridge, Mass.