A Medical Device Daily

Abbott Diagnostics (Abbott Park, Illinois) reported it has entered an exclusive distribution agreement with Verax Biomedical (Worcester, Massachusetts), a developer of rapid tests for detecting bacterial contaminants found in blood cells and tissue. The agreement gives Abbott worldwide rights to market and distribute the Verax Platelet PGD test, which is being evaluated in clinical trials. The Platelet PGD test is a disposable device designed to detect the presence of a broad range of bacterial contaminants in platelets just prior to transfusion. No additional terms of the agreement were disclosed.

Bacterial contamination in platelets and red blood cells represents the single greatest source of risk for lethal infections in transfusion medicine today. About 10 million platelet units are transfused each year to patients in North America, Europe and Asia, and experts estimate that as many as one in every 2,000 units could be contaminated with bacteria.

To combat this risk, the American Association of Blood Banks (Bethesda, Maryland) requires all its members to implement methods to limit and detect bacterial contamination in platelets. Culture testing methods can take up to three days before results are available. In comparison, the Verax Platelet PGD Test, which is designed to target antigens found on all species of bacteria known to be pathogenic to humans, is intended to provide results in less than 30 minutes. Clinical studies of the test are ongoing and are expected to generate data for a 510(k) filing with the FDA.

“Our partnership with Verax will allow us to provide our blood bank and hospital customers with an important test to address the risk of bacterial contamination in transfusion medicine, and further emphasizes Abbott’s commitment to enhance the safety of the world’s blood supply,” said Jeff Binder, senior vice president of diagnostic operations for Abbott.

“This agreement represents a significant milestone in our company’s strategic growth,” said Jim Lousararian, CEO of Verax Biomedical. “Abbott’s vast experience and knowledge of the blood bank industry make them a wonderful partner for us.”

The Verax Platelet PGD Test is based on Verax Biomedical’s Pan Genera Detection technology, which targets common antigens found on the surface of all species of bacteria known to be pathogenic to humans. Clinical trials of the test are underway at University Hospitals Case Medical Center at the Cleveland Clinic (Cleveland, Ohio), and Dartmouth Hitchcock Medical Center (Lebanon, New Hampshire).

Abbott makes pharmaceuticals and medical products, including nutritionals, devices and diagnostics.

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