A Medical Device Daily
Pall (East Hills, New York) on Wednesday reported receiving the CE mark for its Leukotrap Affinity Prion Reduction Filter System, which it said protects against the risk of receiving blood contaminated with variant Creutzfeldt-Jakob (vCJD) prions.
The company said the Leukotrap system is the first and only technology that removes infectious prions that may be the causative agent of vCJD from red blood cells, the most commonly transfused blood component.
vCJD, a fatal neurodegenerative disease, is the human form of bovine spongiform encephalopathy (BSE), also known as “mad cow” disease. It is transmitted by eating contaminated beef and also may be transmitted by a contaminated blood transfusion.
“The availability of our prion reduction filter is a seminal event heralding a new era in blood safety,” said Eric Krasnoff, Pall chairman and CEO, who called the availability of the prion reduction filter “a seminal event heralding a new era in blood safety.”
He said the company is “working very closely with health authorities, starting with the nations hardest hit by vCJD, to help protect the safety of the blood supply and prevent the spread of this insidious disease.”
The CE mark means the new prion reduction filter meets pan-European essential requirements for safety of medical devices and allows its commercialization in Europe.
Pall said the new filter would be evaluated by the UK National Blood Service and the Irish Blood Transfusion Service, with results expected to be available later this year or in early 2006. Of the 40 million red cell units collected annually across the industrialized world, the company said 2.5 million are collected in the UK and 130,000 in Ireland.
Since the first human case of vCJD was identified in the UK in 1994, some 172 cases have been reported worldwide, with the vast majority of them – 155 – in the UK, but with cases also recorded in Canada, Ireland, France, Italy, Japan, the Netherlands, Saudi Arabia and the U.S.
Pall noted that since vCJD can be asymptomatic for about 10 to 16 years, there is no accurate way to determine how many people could currently be harboring the disease or the magnitude of future cases.
In a company statement, Dr. Adrianno Aguzzi of the Institute of Neuropathology at University Hospital of Zurich (Zurich, Switzerland), one of the pre-eminent prion biologists in the world, said, “There have been two probable cases of human-to-human vCJD transmission via blood transfusion. Since there are no clinical signs or symptoms of the disease for many years, a proportion of the UK population could be incubating vCJD and acting as blood donors. The most direct action to reduce the risk of transmission may come from new methods to provide prion protection.”
The Leukotrap Affinity Prion Reduction Filter removes all types of prions in addition to leukocytes (white blood cells) from red blood cells. Studies with the new filter show that it removes 99.9% of the infectious agent from red cells.
Noting that filtration “is currently an integral part of standard blood processing and handling in the UK and many other countries,” Pall said, “this enables easier and more cost-effective implementation of the new prion reduction filter into established . . . practices.”
Pall said that many nations ban blood donations from people who lived or visited countries where BSE-infected cattle have been found. “These donor deferral measures have put increased pressures on the availability of adequate supply of blood for transfusion,” it said. “As the donor population becomes even more limited with each additional residency deferral, it further reduces the potential number of people giving blood and can result in serious blood shortages.”
The company said adoption of the new prion reduction filter “has the potential to support the global need for adequate supplies of safe blood for the benefit of the public health.”
Pall also is developing an ante-mortem test to detect infectious prions in cattle prior to entering the food supply.
MSI seeks Ukraine test kit approvals
Medical Services International (MSI; Edmonton, Alberta) said that both its VScan HIV 1 & 2 and tuberculosis test kits have been submitted for approval by regulatory authorities in the Ukraine. The necessary testing to support the approval request is being completed at this time, MSI said.
The company said it has now applied for regulatory approval of its VScan kits in eight eastern European countries, and is in negotiation with distributors in all eight countries.
MSI said its market studies show that there will be a “significant demand” for the test kits, with the expectation that it will supply in excess of 4 million test kits into the region within a year.
The VScan rapid test kits are available for the screening of HIV 1 & 2, hepatitis B & C, tuberculosis, dengue fever, West Nile virus, syphilis, malaria and prostate cancer.
Dom joins UK’s True Health
True Health (Beckenham, UK), a provider of healthcare pressure relieving systems and social care recruitment services, has named Dr. Henry Dom executive officer responsible for the development of its new business in the social care arena.
The company said Dom brings “great experience of working with social care policy makers and contacts with many UK local government agency budget holders in this sector,” having previously serve as chief executive of Atmagati.
True Health’s primary recruitment clients are the National Health Service and Great Britain’s private nursing home industry. It specializes in providing social care workers, locum radiographers and nurses.
Its core business is supplying proprietary branded specialist pressure-relieving equipment for the healthcare sector.