Medical Device Daily Contributing Writer, and MDDs

BRUSSELS – The European Union has imposed additional quality and safety standards for human tissues and cells, covering processing, preservation, storage and distribution. The move follows the adoption last February of new safety rules for donation, procurement and testing.

The new rules set out accreditation procedures for tissue banks and processes for tissue and cell preparation —including notification of serious adverse reactions and events to national authorities, and annual reporting to the European Union. A tissue establishment must have an approved organizational structure and operation procedures, and must apply a documented quality management system. The rules detail the requirements for staff, equipment and materials used, for documentation and record keeping, and for reviewing quality through audits.

To ensure traceability of all human tissues and cells from the donor to the end user and vice versa, the rules define the basis for a single European identifying code for all donated material. In Europe, these tissues or cells are frequently acquired through cross-border exchange, and EU citizens also receive treatment in other EU countries.

The aim is to provide the highest level of public health protection in all member states, and prevent the transmission of diseases via donated tissues and cells. Member states also will retain the option to apply stricter standards should they wish.

The EU first proposed binding requirements for the safety and quality of human tissues and cells from patient to donor in 2002. That has now resulted in new legislation, and these new technical standards — which must be put into effect at the national level by November 2007 (with a delay until June 2008 for the coding requirements).

Further guidelines concerning the single European identifying code for human tissues and cells are currently under preparation and will be released early in 2007.

OncImmune sets U.S. headquarters

OncImmune (Nottinghamshire, England) said it will locate its North American headquarters and commercial lab in Lenexa, Kansas, a suburb of Kansas City.

The company is developing technology intended for earlier detection of breast cancer than available via mammogram. The company was founded in 2003 to commercialize technology developed in the laboratories of John Robertson, a professor of surgery at Nottingham University (Nottinghamshire).

Dr. Tony Barnes, CEO of OncImmune, said, “Professor Robertson always knew that the product would have to come to the United States to be commercialized. The medical community here is the most aggressive at adapting new technology.”

OncImmune is expected to create 120 new jobs within the next four years in addition to 20 new positions at the University of Kansas . It said it will invest $30 million into area lab operations.

OncImmune will collaborate with the KU School of Pharmacy , KU Higuchi Biosciences Center and the KU Medical Center to transfer its breast cancer technology to other forms of cancer such as lung, prostate and colon.

Netherlands picks PerkinElmer for screening

PerkinElmer (Boston), a developer of health sciences and photonics technologies, reported being selected to provide neonatal screening technology to support an expanded screening program in the Netherlands.

The company will provide four tandem mass spectrometry-based systems, reagents and software to support the country’s five hospital screening centers. The partnership expands the country’s program — intended to reach each of the estimated 200,000 babies born annually in the Netherlands — from screening for three disorders to a total of 14 disorders.

Gregory Summe, CEO and chairman of PerkinElmer, noted that the company recently announced that its technology was selected to expand newborn screening programs in Russia and Israel.

“This agreement further fortifies PerkinElmer’s leadership position in supplying neonatal screening technology and support to countries around the world,” he said.

Summe noted that PerkinElmer has more than 10 years of experience with expanding newborn screening programs using tandem mass spectrometry and more than 20 years experience in the field of newborn screening.

“Early intervention is critical,” Summe noted. “There is broad recognition that simple and inexpensive screenings before a family leaves the hospital and before symptoms appear is highly preferable to responding once a condition has developed.”

“A key consideration, given the number of babies to be screened in the Netherlands and the greater number of disorders being screened, was securing robust software that could support the system and manage the calculations,” Summe said. He noted that up to 100 times more data items will need to be analyzed and reviewed daily.

The Specimen Gate Data Suite laboratory information management system from PerkinElmer will allow the country’s five screening centers to implement a solution that will electronically track laboratory workflow from sample receipt and preparation through analysis, quality control review, reporting and follow-up to advance the pace and precision of the screening program. PerkinElmer will support the program with training, customer support and service to ensure quality.

Brust to head Europe/Americas sales

Invitrogen (Carlsbad, California) said it has promoted Bernd Brust to the newly created position of senior VP of sales for Europe and the Americas.

Brust will be responsible for leading the company’s Europe and Americas sales strategy and customer relationship development.

“Bernd was instrumental in creating a winning go-to-market strategy in Europe, successfully optimizing the strategic mix of direct marketing, web presence, and sales force execution to consistently grow his region every quarter,” said Gregory Lucier, CEO and chairman of Invitrogen. “We have the right formula in Europe, where we are currently growing at strong high single digit rates. Our work now is to bring that same discipline and playbook to the Americas.”

Brust joined the company in 2004 and serves as general manager and VP of European Operations. Susan Lambert, VP of European Sales, will be assuming the general manager and VP of European Operations role.

Invitrogen provides technologies for disease research, drug discovery, and commercial bioproduction.

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