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Grifols Gains CE-IVD Mark for Progenika ID Core XT Kit for Molecular Blood Group Typing

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NEW YORK (GenomeWeb) – Grifols has garnered a CE-IVD mark for ID Core XT, a bead array-based assay for molecular blood group typing, the company said this week.

Barcelona-based Grifols, which sells plasma medicines, diagnostics, and hospital pharmacy products, believes the certification of ID Core XT as an in vitro diagnostic will allow it to reach more European blood donor services and blood transfusion services at a time when they are increasingly adopting new technologies.

"The US and European markets are very much interested in molecular testing for blood banking and are pursuing these kinds of kits to cover the wider needs of special recipients," Antonio Martinez, CEO of Progenika Biopharma, a Grifols company, told BioArray News. "The market is growing, especially in blood centers, which lead the adoption of this technology," he said.

Grifols paid $50 million to acquire a 60 percent stake in Progenika last year, gaining the Derio, Spain-based biotechnology firm's line of immunohematology blood genotyping products in the deal. These included its microarray-based BloodChip, which could be used to determine more than 60 clinically relevant blood group phenotypes from the ABO, RHD, RHCE, Kell, Kidd, Duffy, MNS, Colton, Diego, and Dombrock systems.

Grifols also gained Progenika's ID Core and ID Core+ assays, which are run using the Luminex LX 100 and 200 instruments and screen for 23 and 33 low-frequency antigens, respectively.

The company last year released ID Core XT, which types 37 antigens in the Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright, and Lutheran blood groups within four hours on the basis of a sample.

Grifols maintains that using the test reduces the risk of alloimmunization in patients, where the blood recipient's immune system develops antibodies that can attack and reject the donor red blood cells.

Unlike the other Progenika blood genotyping assays, though, which were sold for research use only, Grifols has pursued regulatory clearance for ID Core XT as a molecular diagnostic.

According to Martinez, by obtaining a CE-IVD mark for the test, more of the firm's target customers will be likely to use it as part of their everyday services.

"In Europe it will be possible to use genotyping results obtained with ID Core XT to select more compatible blood bag units without the need to confirm the results obtained using other techniques," he said. The company is also planning to eventually submit the assay to the US Food and Drug Administration for clearance, Martinez confirmed, but he did not elaborate.

Should Grifols gain FDA approval for its test, it will become an even more direct competitor with Immucor, another major global provider of molecular blood group typing products. Last month, Norcoss, Ga.-based Immucor achieved FDA approval for its microarray-based PreciseType Human Erythrocyte Antigen Test for determining blood compatibility, an assay it gained through its 2008 acquisition of Warren, NJ-based BioArray Solutions.

Immucor secured a CE-IVD mark for PreciseType in 2010. The test can identify 35 red blood cell antigens from 11 blood groups simultaneously, enabling the complete blood typing of patients and donors, and allowing increased transfusion compatibility.

Since gaining FDA approval, Immucor has sought to convert more labs over to its technology. "People see the benefit of an IVD product: they can provide molecularly matched blood to patients while minimizing the regulatory and accreditation risk associated with RUO test use," Joel de Jesus, senior director of marketing for Immucor's molecular business, told BioArray News last month.

But while Grifols may trail Immucor in terms of gaining regulatory clearance for its assay, Martinez was ready with facts that demonstrate the superiority of the ID Core XT assay over Immucor's PreciseType Test.

For one, it uses Luminex technology, meaning that labs that already use the Austin, Texas-based company's instruments can more easily adopt Grifols' system, rather than buying the instrumentation necessary to run Immucor's test.

"This is an open instrument that can be used for other purposes at the blood blanks," said Martinez.

"Additionally," he continued, "the ID Core XT detects more antigens typically relevant for individuals of African origin, which, if they go undetected, can cause alloimmunization, mainly in patients suffering sickle cell disease."

Martinez also claimed that Grifols' analytical procedure is "easier and faster," requiring less turnaround and hands on time, and that the system is more flexible in terms of the number of samples that can be analyzed at once. "The speed and flexibility make it optimal for analyzing both patient and donor samples," he said.

Immucor's de Jesus this week acknowledged that Luminex readers are somewhat common in the marketplace, but noted that they are "not ubiquitous." He also told BioArray News that Immucor developed its IVD and CE-marked assays with "significant feedback from many of the world’s largest blood centers" and "chose a more cost-effective way to read the content for our family of IVD and CE-marked molecular transfusion assays" by offering them on its own AIS instrument, which does not require customers purchase additional consumables, such as beads and rinsing fluids.

In terms of flexibility, de Jesus called it a "double-edged sword" when it comes to FDA approval.

"They are looking for an assay to be proven stable, with robust, repeatable, and well-characterized results as demonstrated by the PreciseType HEA test," de Jesus said.

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