A Medical Device Daily

Gen-Probe (San Diego) has reported the European commercial launch of its PCA3 assay, a new prostate cancer-specific molecular diagnostic test, at the annual meeting of the British Association of Urological Surgeons Section of Oncology (BAUS). The PCA3 test has been CE-marked, allowing it to be marketed in the European Union.

"The European launch of Gen-Probe's innovative PCA3 assay signifies our advancement into cancer diagnostics and continued expansion into international markets," said Steve Kondor, the company's vice president of sales and marketing. "[We are] committed to developing new, more accurate molecular diagnostic tools to detect life-threatening diseases like prostate cancer."

Gen-Probe's PCA3 gene-based test detects the overexpression of PCA3 mRNA in urine. Studies have shown that, in greater than 95% of prostate cancer cases, PCA3 is 60 to 100-fold over-expressed in prostate cancer cells compared to normal cells, indicating that PCA3 may be a useful biomarker for prostate cancer.

Preliminary data show that the PCA3 assay is more specific to prostate cancer than the traditional serum prostate-specific antigen (PSA) test, thus decreasing the likelihood of false positive results. PSA is produced by both cancerous and non-cancerous prostate cells. Non-cancerous conditions such as BPH can therefore cause elevated serum PSA levels that must be investigated, resulting in unnecessary medical procedures and patient anxiety.

"Only 25% to 30% of men who have a biopsy due to elevated PSA levels actually have prostate cancer, therefore the majority of elevated PSA tests are the result of non-cancerous conditions," said Mark Emberton, MD, senior lecturer in oncological urology of the Institute of Urology and Nephrology at University College Hospital (London). "Unnecessary biopsies contribute to patient anxiety and are a burden on the healthcare system. We are optimistic that the Gen-Probe PCA3 test, used in combination with serum PSA, will further identify appropriate biopsy patients and that this will result in better detection and diagnosis of prostate cancer."

The PCA3 molecular urine test is being offered through several European laboratories, including NovioGendix (Nijmegen, the Netherlands), Centre of Applied Molecular Technologies Université catholique de Louvain (Brussels, Belgium), Medi-Lab (Manchester, UK), the Doctors Laboratory (London), Labor Limbach (Heidelberg, Germany) and LCL (Paris).

The test is not approved for marketing in the U.S.

The PCA3 gene was discovered by Marion Bussemakers, MD, while working with Jack Schalken, MD, at the University of Nijmegen (Nijmegen, the Netherlands) and in the laboratory of William Isaacs, MD, at Johns Hopkins University (Baltimore).

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

Gen-Probe said that START Oncology in Europe has reported that prostate cancer is the most frequent cancer among men in Northern and Western Europe, with about 190,000 new cases occurring each year. That represents about 15% of all cancers in men.

In Europe, annual incidence rates per 100,000 men range between 19 in Eastern Europe and 55 in Western Europe. In most countries, the incidence has increased more than any other cancer over the past two decades, Gen-Probe said. There are about 80,000 deaths a year from prostate cancer in Europe overall.

Gen-Probe is a manufacturer of rapid, nucleic acid tests that are used primarily to diagnose human diseases and screen donated human blood.

Austria signs flu vaccine pact with Baxter

Baxter Healthcare SA , a subsidiary of Baxter Healthcare (Deerfield, Illinois), reported that the Austrian Ministry of Health has entered into a preparedness contract with the company that contains an option to purchase 16 million doses of pandemic influenza vaccine, enough to vaccinate the entire Austrian population.

The three-year agreement provides the ministry with future access to the company's cell-based vaccine production capacity in the event of an avian flu pandemic.

"We are proud to provide the advanced science and technology, manufacturing capability and other resources to assist the Austrian Ministry of Health in its efforts to protect citizens from the threat of a flu pandemic," said Joy Amundson, corporate vice president and president of Baxter's BioScience business.

Baxter also is under contract to supply 2 million doses of H5N1 vaccine to the UK government and is working with the U.S. National Institute of Allergy and Infectious Diseases , part of the National Institutes of Health (both Bethesda, Maryland), to develop a cell culture-based H5N1 candidate pandemic influenza vaccine.

Baxter announced preliminary results last month of a Phase I/II clinical trial in 270 healthy adults with its inactivated wild-type H5N1 pandemic vaccine. Preliminary results from the trial suggest that the vaccine is well tolerated in humans. In addition, the preliminary results suggest that the vaccine is highly immunogenic and elicits functional antibodies to H5N1 even at the lowest dose level of 3.75 micrograms.

These preliminary data, which the company noted must be confirmed in a larger study, suggest that the vaccine may provide wider protection for a larger number of people before and during a pandemic.

Importantly, preliminary analysis of serum samples obtained from the study subjects suggests both the neutralization of the pandemic virus contained in the vaccine and cross-neutralization against widely diverse strains of H5N1, including both Hongkong/156/97 and Indonesia/05/05.

Baxter said cell-based systems for production of vaccines offer a number of potential benefits over more traditional, chicken egg-based systems. The company's vero-cell system is capable of producing high yields of influenza virus without the addition of any animal-derived serum.

Through its research and development work in Austria, Baxter has been successful in growing wild-type virus in its vero-cell culture, which means that the company could begin vaccine production without having to wait for high-growth or attenuated virus re-assortants normally used when vaccine is produced in eggs.

Baxter said its technology platform also allows it to implement rapid changes in strains that may be needed for new vaccine formulations.