FDA clears Biotest's full line of blood bank reagents.

As with any industry where competition is limited and the demand is high, the blood transfusion industry in the U.S. has seen dramatic price hikes in blood screening products in recent years, according to Candace Williams, VP of the diagnostic division at Biotest Diagnostics (Rockaway, New Jersey).

Until now, there have been just two full-service vendors to the U.S. blood transfusion industry--Ortho-Clinical Diagnostics (Rochester, New York) and Immucor (Norcross, Georgia)--both of which have been passing along price increases over the past five to six years, Williams told Diagnostics & Imaging Week. Ortho, a Johnson & Johnson (New Brunswick, New Jersey) company, recently passed along a 100% price hike and Immucor a 50% increase.

But increased competition will hopefully change that, thanks to the recent FDA clearance of Biotest's full line of traditional blood bank reagents. With a third full-service vendor in the U.S. blood transfusion market, Williams said the prices of blood-screening products are most likely going to stabilize. It also will add to the security of the industry, she said.

"It's really going to be good for the market on so many levels," Williams said. "The products themselves are very good, quality products [and] they are all monoclonal."

These reagents will be used primarily in hospitals, she said, where they will be used to make sure donated blood is compatible with the recipient prior to a transfusion, and they will also be used by donation centers and reference laboratories.

Williams said Biotest submitted its Biological License Application (BLA) to FDA in September 2006. The regulatory cycle for a BLA is one of the longest regulatory cycles in the U.S., she noted, almost like bringing a new drug to the market.

Biotest says these reagents complement its existing portfolio of automated reagents that work with its Tango optimo automated blood bank system. The availability of these reagents afford customers more comprehensive, cost-effective choices, the company said, calling the FDA clearance a "major milestone" for both Biotest and the industry.