Array-based test maker Progenika this year plans to commercialize assays for blood typing and familial hypercholesterolemia in the US and Europe, and may submit one or both tests to the US Food and Drug Administration for future clearance, according to a company official.
CEO Antonio Martinez told BioArray News this week that the first of these tests, called BloodChip, will launch in the EU and US this year. He said that Progenika, based in Derio, Spain, expects to gain the permission of the Spanish Ministry of Health to begin selling the BloodChip for clinical use in the EU by the end of the first quarter.
Meantime, Progenika hopes to make the BloodChip and the FH product, called LipoChip, available in the second quarter as a service in the US through its newly established Clinical Laboratory Improvement Act-compliant lab in Cambridge, Mass.
The commercialization efforts follow a year of activity that saw Progenika open its 12-person US office, establish a sales and marketing team in Madrid, Spain, to raise the company's international profile, and expand its Derio headquarters (see BAN 7/10/2007).
BloodChip uses an internally manufactured genotyping array to determine over 60 clinically relevant blood group phenotypes from the ABO, RHD, RHCE, Kell, Kidd, Duffy, MNS, Colton, Diego, and Dombrock systems.
The chip, designed to decrease the rate of alloimmunization, is recommended for typing pregnant women who are RHD negative and at risk of maternal alloimmunization. It is also meant to be used by multiple-transfused patients, such as those with sickle cell anemia, thalassemia, or those undergoing chemotherapy.
LipoChip, which received a CE Mark in 2004 and is pending a US launch as a laboratory-developed test, surveys samples for mutations in the low-density lipoprotein receptor gene and the familial defective Apolipoprotein B-100 gene, both of which hinder the removal of cholesterol from the blood and contribute to coronary artery disease and atherosclerosis.
The BloodChip originally won a CE Mark for research use in February 2008, but Progenika had to validate its RHD markers in 3,000 samples before it could begin selling the array for clinical use across the EU. To demonstrate that the chip would be suitable for use across Europe, Progenika genotyped samples from the UK's National Blood Service, the University of West England in Bristol, the University of Ülm in Germany, the University of Lund in Sweden, and blood banks in the Czech Republic, Spain, and the Netherlands, Martinez said.
"We finished this validation at the end of last year and we communicated this to our Ministry of Health in December," he said. "We hope to have it CE Marked by March, but first they have to audit our facilities."
During this validation period, Progenika also began installing systems to support its arrays in Spain. According to Martinez, reference blood banks in Barcelona, Madrid, Santiago, and Zaragoza are using the BloodChip to type blood. Martinez said that it is Progenika's ambition also to install systems to support BloodChip at blood banks and services throughout Europe once the CE Mark for clinical use is achieved.
Commensurate with the European launch of BloodChip will be the launch of blood and FH genotyping services through Progenika's lab in Cambridge. Progenika opened the 6,000-square-foot facility on MIT Tech Square last May and is in the process of negotiating agreements with different providers of blood and FH testing that will support the debut in the second quarter.
In the blood genotyping testing market, a rival will be Warren, NJ-based BioArray Solutions, which was acquired by Atlanta-based Immucor last year for $117 million (see BAN 3/18/2008).
BioArray Solutions' technology provides 4,000-feature arrays in automated 8- and 96-chip formats. In 2005, the firm received FDA clearance to sell its extractable nuclear-antigens immunoassay, which profiles six antibodies associated with autoimmune diseases and connective tissue disorders, including systemic lupus erythematosus, mixed connective tissue disease, Sjögren's syndrome, scleroderma, and myotisis (see BAN 6/22/2005).
During Immucor's call last week to discuss its fiscal second-quarter earnings, Immucor President and CEO Gioacchino De Chirico told investors that the BioArray Solutions platform had attracted interest from several European customers, and that Immucor is currently designing a fully automated instrument to support BioArray Solutions' platform.
In terms of rivals for LipoChip, current testing methods still involve basic blood tests that monitor cholesterol and LDL levels, according to the National Human Genome Research Institute.
As it gears up for the European and US launches of BloodChip and LipoChip, Progenika is also preparing to begin negotiations with the FDA for possible submission of the tests, though Martinez said the firm has not yet decided the regulatory route the chips will take.
Though Progenika is not an instrument vendor, it recommends hybridization systems and scanners from other companies, like Tecan, Roche Ventana Medical Systems, and Innopsys, for use with its arrays.
"During 2009, we hope to negotiate the best route for these tests with the FDA," Martinez said. He said that Progenika has built a Good Manufacturing Practices-compliant manufacturing and R&D facility adjacent to its headquarters in Derio, located on Spain's north coast, to help it enter the US and European molecular-diagnostics markets.
While it waits to start talks with the FDA, Progenika is also developing other arrays for research use. Two of the most developed arrays include PharmaChip and IBDChip.
PharmaChip monitors 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.
"PharmaChip will be used in pharmacogenomic studies," Martinez said. "We are starting with clinical validations to identify clinical applications for the product," he said. "Right now, the tool is offered only for research. We are interested in doing clinical validation, so we are recruiting the samples from different hospitals in Spain," he added. "We are especially interested in applying the PharmaChip for use in psychiatry, organ transplantation, and oncology."
The IBDChip 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.
Martinez said that the IBDChip has already been CE Marked and is now available in Spain. Progenika is now pursuing the clinical validation of IBDChip in 3,000 samples representative of the EU population. Martinez said that he believes the statistical analysis related to that validation will be completed by the second quarter.
Progenika also has research programs in inflammation, multiple sclerosis, osteoporosis, and fibromyalgia.
Martinez said that Progenika is waiting to see how the adoption of BloodChip and LipoChip proceeds in the US, as well as its discussions with the FDA, before it decides on whether or not to "export" any of its newer chips, like IBDChip or PharmaChip, to its CLIA lab in Cambridge. "If things go well, we can think about offering these arrays in the US sometime in 2010," he said.