It's in the genes (11/30/2007)

Of the millions of people receiving blood transfusions in the United States each year, thousands face complications some of which can be life-threatening as a result of a mismatch between the donor and recipient.

Progenika, Inc., the U.S. subsidiary of Progenika Biopharma, the European molecular diagnostics company, unveiled in the United States for the first time a new genetic blood test that sharply reduces the chance for a transfusion mismatch. Data showing clinical validation in Europe was presented at the annual meeting of the American Association of Blood Banks. The test was developed by the Bloodgen consortium, a group of leading European blood banks and research institutions, including Progenika Biopharma.

Professor Neil Avent of the University of West England, Bristol, leader of the Bloodgen consortium and a member of Progenika Biopharma's scientific advisory board, said that 1,000 patient, donor and new-born blood samples collected in Europe were tested with BLOODchip®, the trade name for the company's new genetic test which simultaneously determines nine blood types.

Professor Avent, who is director of the Centre for Research in Biomedicine at the British university, said, BLOODchip® proved to be significantly more accurate than serology, the current, widely-used blood test to determine compatibility. Of 1,000 samples analyzed by the BLOODchip®, only two genotypes were incorrectly scored. Specifically, 958 samples matched perfectly between the BLOODchip® and serological methods. Of the 42 discrepancies, 40 were resolved in favor of the BLOODchip®.

The clinical validation studies were conducted as part of the company's application for the CE Mark -- European equivalent to approval by the Food and Drug Administration (FDA). In coming months, the company also expects to apply for FDA approval in the United States.

Clearly, BLOODchip® offers an excellent and rapid solution to perform routine high throughput and large-scale clinical genotyping of blood groups, Avent said.

Patients requiring multiple blood transfusions, such as those suffering from thalassemia, sickle cell disease, cancers such as lymphomas and leukemia, are particularly susceptible to mismatches, as are patients with blood type D-negative, and pregnant women.

Uniquely, BLOODchip® also analyses RhD, a major blood group system that is generally considered to be one of the most clinically significant blood groups. It also is the most polymorphic, often containing variations due to deletions, gene conversions, and so-called missense mutations, which causes significant problems for accurate detection using serological means.

These patients over time develop antibodies that reject imperfectly matched blood transfusions, a process known as alloimmunization, which can lead to serious illness and life-threatening side effects. BLOODchip® was developed with these communities in mind.

Once cleared by the FDA, Progenika, Inc., intends to market BLOODchip® to blood centers and hospitals in North America in an effort to improve the safety of transfusions.

The American Association of Blood Banks has nearly 2,000 institutional members that include community and hospital blood banks, hospital transfusion services and laboratories, plus about 8,000 individuals, including scientists, physicians, nurses and other health care providers.

Note: This story has been adapted from a news release issued by Basque Research

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