Rockville, Maryland, Sept. 17 (Bloomberg) -- Abbott Laboratories' PRISM blood screening device could improve the safety of the U.S. blood supply and should be cleared for sale, a panel of experts said.
The advisory panel for the U.S. Food and Drug Administration voted unanimously to recommend the full agency approve the device, for use in the blood screening done by hospitals, blood banks and by the companies that manufacture blood products.
In backing the device, the panel followed the urging of
representatives from numerous blood banks who said the machine cut down on thousands of manual steps each day at their testing centers, and eliminated the potential for human errors as well as negligence in the testing process.
``This will allow us to catch more infected donors while rejecting far fewer safe donors that must be deferred using the
current tests,'' said Louis Katz, a spokesman for the America's Blood Centers, a national blood bank organization. ``From our review of the available data, the PRISM is virtually tamper proof.''
Abbott is the 7th largest U.S. drugmaker by sales.
Today's review of the PRISM device comes during a two-day panel meeting on blood products and amidst increasing concern about the safety of the blood supply. A recent report by the General Accounting Office -- a fact finding office for the U.S.
Congress -- found that the FDA's safety guidelines for so-called plasma products are largely adequate but too often ignored or followed imperfectly by companies.
Companies including Bayer AG, Alpha Therapeutics Corp., Baxter International Inc. and Centeon LLC use plasma -- one component of the whole blood given in donations -- to produce essential treatments such as the immune system-boosting drug known as immune globulin.
Centeon is only the latest company to run into manufacturing
problems. A joint venture of Germany's Hoechst AG and France's Rhone-Poulenc SA, the company was recently shut down by the FDA because it repeatedly failed to follow the agency's manufacturing safeguard rules. Centeon was also forced to suspend operations at two different times in 1996 and 1997 because of manufacturing and contamination problems, one of which led to FDA investigations into at least 12 cases where people may have been infected by tainted Centeon blood products.
The PRISM is a piano-sized machine that regulates the testing process and can detect a full range of possible blood contaminants including hepatitis and HIV, Abbott said.
FDA members told the panel they expect the FDA's final review of the device to be completed by Oct. 20.
While the device would be a boon to blood banks and could enhance the safety of the blood supply, an approval is unlikely to significantly affect the company's overall sales, analysts said.
Still, the panel backing represents a win for Abbott, which has lost its dominance in blood screening devices, as Johnson & Johnson and others have build their presence in the market.
``It really gets Abbott back on the high ground, and it's probably got more commercial appeal than people think,'' said Daniel Lemaitre, an analyst with SG Cowen Securities Corp. In
terms of a psychological boost for the company, ``This is a huge win,'' he said.
The device is already used in Europe and the Pacific Rim, company officials said.
Currently, the safety and purity of the U.S. blood supply depends upon a series of manual tests run on each individual blood donation. The FDA requires blood processing labs to follow a system of checks and balances during this testing process.
Called Good Manufacturing Practices, or GMP, the system is designed to safeguard against mistakes along the way. It is, by nature, dependent on the careful participation of companies and
on the avoidance of human error.
For example, laboratory technicians must check and double-
check that the right amounts of the right chemicals are used in thousands of tests, and document every step.
Any breakdown in GMP offers to compromise the safety of the blood supply regardless of whether a unit of blood is actually contaminated.
``These represent thousands of incidents each year that are investigated by the industry and FDA,'' said James Stewart, who presented data on the device for Abbott. ``Behind these lies the possibility that there are many (more) incidents which go
The PRISM automates this entire process, cuts down on the sheer number of manual steps -- by about 65 percent -- and
reduces the potential for mistakes, he said.
And because it takes much of the uncertainty out of this
process, the company projected the device could prevent the unnecessary re-screening tens of thousands of units of blood each year, Abbott said.
``This technology offers a significant public health
benefit,'' Stewart said.
Finally, company officials said the machine is more sensitive than some existing tests. For example, it can detect some viruses about a week earlier in the course of an infection than current tests. That may lessen the chances of tainted blood reaching the blood supply.
There is a short period after infection before the body musters specific antibodies -- which is what most screening test look for -- for a particular virus. That lag time is the reason donation centers don't accept blood from donors who have recently gotten a tattoo, engaged in unsafe sexual practices or who carry other risk factors. Sensitivity to contamination sooner after a
donor has been infected narrows the possible window for an error.
The panel vote came after the close of trading on U.S. markets. Shares in Abbott Park, Illinois-based Abbott fell 9/16 to close at 42 9/16.
The FDA generally follows the advice of its expert government panels, but is not required to do so.