A Medical Device Daily Staff Repoprt

Biopure (Cambridge, Massachusetts) reported the receipt of a comment letter from the UK's Commission on Human Medicines addressing the company's application for marketing authorization for Hemopure [hemoglobin glutamer — 250 (bovine)] pending with the Medicines and Healthcare products Regulatory Agency (MHRA).

The company said the letter states that the commission was "reassured" on a number of the questions raised in its initial comment letter, but indicated that other pharmacological and clinical issues either were not yet resolved by the submission made by Biopure last November or were resolved only in part.

The comment letter posed several new questions and invited Biopure to discuss the issues with the MHRA team of medical, statistical and pharmaceutical reviewers.

The company said the commission has not advised it to withdraw the application. Biopure said it has been advised that such a request would be the customary means of indicating futility or rejection of an application.

"We intend to proceed by meeting and consulting with the UK regulatory review team, as suggested, as soon as possible, for clarification of their requirements," said Biopure Chairman/CEO Zafiris Zafirelis. "Based on preliminary advice, we are encouraged to proceed with the application."

Biopure said that according to the commission, there are no major pre-clinical issues. The major remaining issues, the company said, relate to quality, clinical efficacy, safety and the reliability of data monitoring and auditing of clinical trials.

The commission also noted the lack of data in trauma patients as a concern related to the potential for off-label use of Hemopure.

Data support Gen-Probe prostate test

New clinical data from a study of 570 men published in the Journal of Urology support the use of Progensa PCA3 as a tool for diagnosing prostate cancer, said test manufacturer Gen-Probe (San Diego).

The company said the study "confirms that Progensa PCA3, the world's first gene-based urine test to help detect prostate cancer, can provide clinicians with valuable information that helps guide diagnosis." The test was launched last year in the UK.

Gen-Probe acquired worldwide diagnostic rights to the PCA3 gene from DiagnoCure (Quebec City) in November 2003. DiagnoCure is the exclusive worldwide licensee for all diagnostic and therapeutic applications of the gene.

"We found that the percentage of biopsy-positive men identified directly increased with the PCA3 score," said Dr. Jack Groskopf, director of oncology R&D at Gen-Probe and co-author of the study. "We also confirmed that the PCA3 score was independent of prostate size; this is important because PSA levels can be elevated in men who have enlarged prostates due to non-cancerous conditions."

Men with a PCA3 score of less than 5 showed a positive biopsy rate of 14%; however, a PCA3 score greater than 100 showed a 69% biopsy positive rate. Results were similar regardless of a patient's PSA levels or whether they had undergone repeat biopsies.

The study expands on findings from a previous study conducted by Dr. Leonard Marks of the UK's Urological Sciences Research Foundation published in the March 2007 issue of Urology.

Gen-Probe said it has launched www.PCA3.org as the first patient and professional website dedicated solely to PCA3, "providing patients and healthcare professionals with information about how PCA3 can be used to help tackle the UK's most common cancer affecting males."

The company said Progensa PCA3 "addresses some of the limitations of existing diagnostic tools." For example, it said, prostate-specific antigen (PSA) "is commonly elevated for reasons not related to prostate cancer, and as a result, PSA testing produces many 'false positive' results, which can burden patients and the healthcare system."

In contrast, the company said the genetic marker PCA3 "is elevated only in cancerous prostate tissue, making it a more specific indicator of cancer than PSA, potentially reducing the number of unnecessary biopsies."

Progensa PCA3 is the first CE-marked test to use the presence of PCA3 (a genetic marker for prostate cancer) to predict prostate cancer, and can be used in conjunction with current tests to confirm diagnosis. PCA3 is over-expressed, relative to benign cells, by 60- to 100-fold in more than 90% of prostate tumors.

The test is marketed across the European Union and is offered through Medi-Lab and The Doctor's Laboratory in the UK.

CE-mark, ISO certification for Orthocrat

Orthocrat (Petach Tikva, Israel), a developer of orthopedic pre-operative templating software, announced said it has received CE-mark certification, along ISO 13485:2003 certification.

The company earned the certifications after a review process, including on-site inspections, by Kema Quality, a European "notified body" specializing in testing and certification.

"In the very regulated and competitive medical industry, it is critical that medical device companies employ the most stringent quality standards," said CEO Zeev Glozman. "With ISO and CE certification, in addition to the FDA clearance we received in the U.S., we now have a global stamp of approval on our safety, performance and efficacy standards."

Traumacad, Orthocrat's pre-operative planning tool, complies with the requirements set out in European directives related to medical devices.

ISO 13485:2003 is an international standard designed to provide medical device companies with a common approach to applying quality management systems.

µ-Slide Angiogenesis introduced by ibidi

ibidi (Martinsreid, Germany), a solutions supplier for biomicroscopy, has released a new carrier for angiogenesis assays, the µ-Slide Angiogenesis, at the Analytica 2008 meeting.

Angiogenesis is a fast-growing research field focused on the formation of new blood vessels in the developmental biology of embryos, as well as in cancer research.

ibidi produces micro-Slides (µ- Slides), a "Lab-on-a-Slide" technology for the analysis of cells and biomolecules. The company says the µ-Slides represent "a new family of flow-through devices for the functional analysis of living cells and consisting of different slide types for cell-culture and high-end optical microscopy."