Diagnostics & Imaging Week Contributing Writers

The prospects for pharmacogenomics have been oversold, and the era of personalized medicine based on gene testing remains more than 15 years away. That is the conclusion of “Personalized Medicines: Hopes and Realities,” a study published recently by the Royal Society, the UK’s national academy of science.

As part of the hype around the Human Genome Project, expectations were raised that sequencing the genome would lead within a few years to personalized medicine. “But the reality is still many years away,” the report said. “There are some examples [of applications of pharmacogenomics] around today, but the complex, multiple causes of diseases mean it will be 15 to 20 years before a patient’s genetic makeup is a major factor in determining which drugs they are prescribed.”

Not only is the development of personalized medicines hampered by the many gaps in understanding of how genetics relates to causes of disease, but also because healthcare professionals do not have the relevant training, and across Europe there is a shortage of researchers specializing in pharmacogenomics.

The report recommended there be financial incentives to encourage pharmaceutical and biotech companies in Europe to work on pharmacogenomic drugs with relatively small markets.

It also called for preparatory groundwork such as gathering and collating data on how genetics influence response to existing drugs in a patient population. That would reduce the number of adverse reactions and ensure drugs are given only to patients for whom they will be effective.

To date, pharmacogenomics has had little impact on clinical practice. The most notable impact has been in testing cancer patients to see if they will benefit from drugs such as Herceptin in treating breast cancer and Gleevec in treating leukemia. Genetic testing also is in use in some clinical trials to select likely responders.

The report said there should be more intelligent use of the genetic data companies are beginning to collect during clinical trials, and monitoring should continue once products are on the market, with the aim of linking genetic variability with clinical outcome. It calls for monitoring to be a compulsory extension to the current system of clinical trials.

The gathering and analysis of pharmacogenomic patient data introduces issues of storing the information, access and to what extent it is anonymous. Governments need to outline the ethical framework for researchers who will be creating or accessing large patient data-bases.

Pharmacogenomics might be valuable in fighting diseases such as malaria, tuberculosis and AIDS, but variation in the laws for conducting genetic research makes it difficult to combine data at a pan-national level. The guidelines and regulation for conducting genetic research across international borders need to be reviewed, said the report.

In the UK, the Department of Health is funding six pharmacogenomic projects, which give a flavor of the complexity and the scale of the research that needs to be carried out before the widespread application of pharmacogenomics. The largest of those is assessing the importance of CYP2C9 variants in provoking adverse reactions – including serious bleeding – to the commonly administered oral anticoagulant warfarin.

The study will involve the genetic testing and subsequent monitoring of 2,400 patients with cardiovascular disorders who are prescribed the drug. CYP2C9 is a member of the cytochrome P450 family of genes that are involved in the metabolism of genes in the liver.

Ciphergen, UCL in cancer research agreement

Ciphergen Biosystems (Fremont, California) said it has signed a research and license agreement with University College London (UCL) and the university’s commercial unit, UCL BioMedica plc, to utilize Ciphergen’s suite of proteomic solutions to further their ongoing research in ovarian cancer.

The solutions include Deep Proteome, Pattern Track Process and the ProteinChip System.

The principal investigator, Professor Ian Jacobs of UCL, is president of the European Society of Gynecological Oncology and recognized as a world authority on ovarian cancer. He and his team manage the United Kingdom Colla-borative Trial of Ovarian Cancer Screening (UKCTOCS), which involves 200,000 women and is said to be the largest screening trial in the world.

Ciphergen said it and its University College London collaborators “will work together to further validate and characterize ovarian cancer biomarkers, as well as discover potential new biomarkers.” They plan to utilize samples from a new prospective collection of more than 1,000 patients with ovarian cancer, benign neoplasms and 4000 healthy controls recruited through 10 UK centers.

This research is expected to address multiple clinical questions, including validation of markers described in Cancer Research in August 2004 and the discovery of additional biomarkers that distinguish ovarian cancer from other gynecologic masses.

Under the terms of the agreement, Ciphergen will have exclusive rights to license discoveries made during the course of this collaboration.

“It is our belief that this technology could lead to breakthrough discoveries in the area of women’s health,” said Jacobs. “Combining Ciphergen’s expertise in translational proteomics with our clinical resources and research expertise is an important step in our efforts to accelerate the development of new diagnostic approaches to ovarian and breast cancer.”

TriPath adds to UK contracts

TriPath Imaging (Burlington, North Carolina) said that Medical Solutions, its licensed distributor in the UK, has been awarded an exclusive five-year contract to supply the SurePath liquid-based Pap test to the Central Manchester and Manchester Children’s University Hospitals and Bolton Hospitals NHS trusts.

Paul Sohmer, MD, chairman, president and CEO of TriPath Imaging, said, “With this contract, we now have cumulative commitments that represent nearly 30% of the market in the UK, 32% in England and Wales.”

He said the company expects to continue to grow its business in the UK as other regions finalize their decisions on Pap testing.

390,000 HIV kits to China customers

Medical Services International (MSI; Edmonton, Alberta) said that by the end of its first fiscal quarter on Sept. 30, it had shipped more than 390,000 VScan HIV test kits to 12 hospitals in southern China.

The company said it expects to begin shipping to an additional five Chinese hospitals before the end of this month. In addition to the hospitals, MSI’s Shanghai facility is shipping to military facilities and distributors throughout southern China.

MSI said additional hospitals and other medical facilities are contacting the Shanghai facility regularly about the VScan HIV test kits.