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 Medical Device Daily. She said Ortho, a Johnson & Johnson (New Brunswick, New Jersey) company, recently passed along a 100% price hike and Immucor a 50% increase.
But increased competition may 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 also will 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 the 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.
"The ability to efficiently and accurately screen and type blood, as well as match patients and donors is critical, as are the tools we provide the blood banking industry," said Bill Weiss, president of Biotest. "The approval of our traditional reagent line provides laboratory professionals with a vital alternative for their testing needs. Accessibility to more options at competitive prices is a significant offering in today's competitive market. And, as a full-service supplier for laboratories' complete blood typing and testing needs, Biotest is not only helping to strengthen the industry, but is also solidifying its commitment to customers and their patients."
The traditional reagents that received FDA clearance include Seraclone Blood Grouping Reagents, Biotestcell Reagent Red Blood Cells, Rare Typing Reagents, Anti-Human Globulins; Enhancement Reagents, and Control Sera and Red Cells.
Biotest's Reagent Red Blood Cell products include three configurations for antibody screening, two antibody identification panels, Coombs control cells and reverse ABO products. Rare typing reagents will include anti-C, anti-E, anti-c, anti-e, anti-Lea, anti-K, anti-k, anti-Fya, anti-Jka, anti-Jkb, anti-M, anti-N, anti-S, anti-s and anti-P1.
All antisera are monoclonal and many of the clones have never previously been available in the U.S. Biotest said its reagents are recognized for their high levels of sensitivity and specificity and are competitively priced.
Biotest Diagnostics is a subsidiary of Biotest AG (Frankfurt, Germany), a company that supplies traditional and automated blood bank solutions worldwide. Williams said it has been in business since the 1940s and its reagents are available in 130 countries.
Biotest says it provides a 24/7-tech support hotline for its customers. Biotest's blood bank field staff — comprised of medical technologists with donor center and hospital transfusion service experience, and field service engineers with years of diagnostic industry experience — are on call and available to support implementation that is customized to meet the individual facility's needs and provide fast and effective on-site troubleshooting, the company noted.