A Medical Device Daily

Blood substitute and oxygen therapeutics developer Biopure (Cambridge, Massachusetts) has reported that it will apply in mid-2006 for CE-marking of its investigational oxygen therapeutic Hemopure [hemoglobin glutamer-250 (bovine)] for the treatment of acute anemia in elective orthopedic surgery patients.

"This planned submission will be our first marketing application in Europe and will incorporate the considerable work we've been doing to address the Food and Drug Administration's questions regarding our previous U.S. marketing application for this orthopedic surgery indication," said Zafiris Zafirelis, president and CEO of Biopure. "We intend to use existing data and new analyses of our two completed Phase III surgery trials to support the product's risk-benefit profile in this indication in Europe. We're currently preparing the European application and are continuing with our previously announced development plan for Hemopure in cardiovascular ischemia and out-of-hospital trauma."

The company said that the European Agency for the Evaluation of Medicinal Products (EMEA) has notified the company that Hemopure is eligible for submission of a marketing application through the EU's centralized filing procedure for all 25 member states.

Biopure said that in December it began meeting with regulatory authorities of individual countries to assess whether to apply through the centralized or decentralized EU procedure and to determine which countries would be most appropriate for an orthopedic surgery indication.

The company said it also is considering submitting the marketing application to non-EU European countries. "The product's approvability will only be assessed once a complete marketing application has been formally submitted for review," it said.

The clinical section of Biopure's application will include data from a 688-patient Phase III orthopedic surgery trial conducted in the U.S., South Africa, Europe and Canada, and from a 160-patient Phase III general non-cardiac surgery trial conducted in South Africa and Europe.

More CE-marking news

Tm Bioscience (Toronto), a developer of genetic tests, reported that its Tag-It Cystic Fibrosis (CF) Kit has won the CE mark.

The Tag-It CF Kit is used to simultaneously detect and identify mutations and variants in the CF transmembrane conductance regulator (TR) gene in human blood or blood spot specimens in order to determine CF-carrier status in adults, as an aid in newborn screening, and in confirmatory testing in newborns and children. Tm said that performance testing has established that the Tag-It CF Kit is 100% accurate and greater than 99.9% reproducible and precise.

The kit is also the first multiplexed human disease genotyping test to be cleared by the FDA as an in vitro diagnostic device, Tm said.

"Having the CE mark on our Tag-It CF test expands our reach into the European market for CF testing and further asserts our leadership position in the clinical genetic testing market," said Greg Hines, president and CEO of Tm.

"A proven, highly accurate and affordable cystic fibrosis molecular test is needed for the European market for carrier screening and as a tool for diagnosis of newborns," said Dr. Jeremy Bridge-Cook, vice president, marketing and business development.

CeMines (Golden, Colorado) reported that its CeMines International subsidiary, CeMines Estonia OU (Tallinn, Estonia), received notice that the company was granted CE-marking for its CellCorrect Lab Detection Kit for clinical use. The kit is a minimally invasive molecular blood test to aid in diagnosing lung cancer. It will be marketed and distributed in the EU under the brand name CellCorrect KvA-40 Lab Kit.

Roger Attick, president and CEO of CeMines, called the clearance the company's "most significant accomplishment to date ... . We believe that our integration of the CellCorrect diagnostic array protocol and CeMines' Molecular FingerPrinting bioinformatics applications will eventually establish the CellCorrect product family as the most cost-effective and operationally efficient DX modality available today."

CeMines last May reported filing an FDA 510(k) application to clear CellCorrect Lab for clinical use. CeMines said it has had "productive discussions with the FDA" and expects "substantial forward progress later in 2006."

CeMines, founded in 2000, specializes in cell biology and regulatory network research and development that is principal to commercialization of novel clinical products for worldwide use in diagnosis and possible treatment of cancer.

Xceleron to participate in microdosing study

Xceleron (York, UK), a bioanalytical contract research organization specializing in accelerator mass spectrometry (AMS), said it has been asked to lead the European Union Microdose AMS Partnership Programme (EUMAPP).

"The award of EUR 2.1 million is confirmation that the EU recognizes the value of microdosing in drug development and that Europe is to play a leading role in the further development of this technology," the company said in a statement.

The 30-month EUMAPP project gathers together 10 organizations from five countries (UK, Sweden, the Netherlands, France and Poland), with the aim of certifying high- and low-voltage AMS technologies as the most appropriate methodologies for the measurements required by microdosing studies.

Xcelron said that the AMS microdosing approach "offers new ways of developing drugs by bridging the gap between the laboratory and the clinic by:

• demonstrating the reliability of the approach for predicting drugs' pharmacokinetics when used at pharmacological doses;

• certifying AMS as the most accurate, appropriate and powerful technology for reproducible measurements required by microdosing studies;

• and developing in silico modeling application to predict parameters from microdosing studies."

Professor Colin Garner, Xceleron's CEO, said, "This program follows on from the successful CREAM trial and will add seven more drugs to the growing portfolio of compounds tested by Xceleron."

Fergal Donnelly, MD, scientific officer for Biotechnology and Applied Genomics in the European Commission, said, "the EUMAPP provides a tremendous opportunity for Europe to maintain its leading role in the field of microdosing. Companies of this nature, such as Xceleron, having pioneered human phase microdose studies, will play a vital role in successful exploitation of EU-funded research."