‘Highly Sensitive’ HIV, Hepatitis C Blood Screening Test Approved; Experts Question Cost
The FDA yesterday approved Procleix, a nucleic acid test manufactured by Chiron Corp. that can detect in blood small amounts of HIV and hepatitis C, thus allowing blood banks to determine the presence of either virus much earlier than with previous tests, the Contra Costa Times reports (Silber, Contra Costa Times, 3/1). The approval of the "highly sensitive" Procleix, which has been used experimentally worldwide since 1999 and is currently used on two-thirds of the American blood supply, will eventually result in the test becoming mandatory but will also allow Chiron and San Diego-based Gen-Probe, the companies that developed the test, to "sharply" increase the price to "whatever the market will bear," expected to be around $10 to $15 per unit of blood, the New York Times reports. The test, which directly measures the viruses' RNA by increasing it "billions of times to detectable levels," will shorten the time between infection and blood test detection from 22 days to 12 days for HIV and from 70 or 80 days to 10 to 25 days for HCV. Although health experts "applaud the health benefits" of the test, saying it will increase the safety of the U.S. blood supply, others question the test's cost effectiveness. "I'm ambivalent," Michael Busch, vice president for research at Blood Systems, said, adding that "we're spending enormous resources" on a technique that does not prevent many infections. Experts say that the blood supply in the United State is already "so safe" that the money used for this new test might be "better spent" on preventing transfusions of blood of the wrong type, a "greater risk" than contracting HIV or HCV from a blood transfusion, the New York Times reports. Over the past three years, the new test has detected eight cases of HIV and 113 cases of HCV that were not caught by other blood screening methods. The Times says that the estimated $10 to $15 cost will not add much to the cost of a unit of red blood cells, which currently costs a hospital $100 to $200. In addition, the nucleic acid testing will eliminate the need for a $2 to $3 test used to detect HIV viral proteins. But Dr. James AuBuchon, chair of the pathology department at Dartmouth-Hitchcock Medical Center in New Hampshire and director of the hospital's blood bank, estimates that the test will cost $1 million for each year of life that is saved, meaning the test is "far less cost-effective than just about any other medical-surgical intervention." However, the public "seems to favor" improving the safety of the blood supply despite the cost (Pollack, New York Times, 3/1).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.