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| Karen Midthun, director of FDA's Center for Biologics Evaluation and Research--Courtesy of FDA |
Immucor has scored the latest molecular diagnostics first. FDA officials approved the Georgia company's gene-based test to determine red blood cell types during transfusions.
Specifically, regulators gave the go-ahead to Immucor's PreciseType Human Erythrocyte Antigen Molecular BeadChip Test. The FDA noted it's the first molecular diagnostic test with U.S. approval to determine blood compatibility before a transfusion. Approval follows review by the FDA's Blood Products Advisory Committee on March 18, 2014, which voted that the test is safe and effective for its intended use. Panel recommendations aren't binding, but the FDA usually follows suit. PreciseType has had a CE marking in Europe since 2010.
Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a statement that the test will give clinicians an option beyond serological typing and could help improve patient care options in certain situations. Immucor President and CEO William Hawkins noted in his own prepared remarks that his company's new product makes antigen typing of donors and patients both viable and cost-effective, allowing for more targeted matches in an economically feasible way.
"Until now, expansive antigen typing of most donors and patients was impractical and cost-prohibitive for blood banks and hospital transfusion centers, given the time and complexity of the workup," Hawkins said. "We are proud to be at the forefront of a new era--made possible today with the FDA's approval of our PreciseType HEA test--where precise, molecular blood donor/patient matching can finally become the standard of care."
In other words, the new diagnostic helps clinicians more closely match donor blood to patients' DNA. That's a particular issue for patients with blood disorders such as sickle cell disease, which require multiple transfusions. The alloimmunization rate, or rejection of transfusions, can hit as high as 36% in those cases, because the donor blood didn't match a patient's own blood precisely enough to avoid complications. The Immucor test should allow for better blood donor matches, reducing complications and avoiding adding costs to the healthcare system as a result.
Immucor said PreciseType can spot 35 red blood cell antigens at the same time from 11 blood groups. Such a test will also help simplify how donors with rare or unusual antigens are identified. With that ability, blood banks can save unusual blood donations for special cases, the company said.
Bio Array Solutions in Warren, NJ, will manufacture the test.
- read the company's release
- here's the FDA's announcement