The National Clinical Genomics Initiative responds to a growing need to link advances in molecular biology with clinical medicine, in order to develop new diagnostic tools and disease treatments which are based on molecular genetic discoveries. Scientific studies have demonstrated repeatedly that it is possible to discern patterns of gene mutation and expression that correlate with clinical outcomes by examining well-characterised and appropriately preserved human tissue samples that are left over after patients undergo surgical treatment for their disease. In this way, researchers can define which of the genes are the most important in the origin and progression of disease.
In spite of the potential research importance of these clinical samples, they are currently discarded as medical waste following surgery and other medical procedures. Through its collaborations with medical institutions in the National Clinical Genomics Initiative, Ardais facilitates the collection and archiving of these excess human tissues and converts the samples and associated medical information into unique formats for research. The National Clinical Genomics Initiative is the first large scale, organised effort to address the challenge of building a national tissue and information library with the necessary assembly of scientific and medical expertise, sophisticated bioinformatics and logistics tools, and bio-ethical safeguards.
Michael Jones, M.D., Chief of Pathology at Maine Medical Center and Principal Investigator of the project commented: "This is an important National Initiative and an excellent opportunity for Maine Medical Center. It allows the Medical Center and, in particular, our patients, to make an important contribution to cutting edge genomic research. The association with other major research institutions represents a significant gain for Maine Medical Center's research efforts and, in fact, the Maine scientific community at large."
E. J. Lovett, Ph.D., Associate Vice President for Research at MMC added: "Our researchers also gain preferential access to an ever-expanding national library of high-quality clinical materials and information. And, very importantly, we provide our patients with an opportunity to volunteer to make a difference to future patients, who might be friends or relatives."
Ardais Corporation functions as a bridge between medical institutions and the scientific research community, by systematising and standardising the collection and processing of large numbers of high quality clinical materials and associated information. The company has recently launched its repository, known as the BIGR Library, comprised of research-quality clinical materials and associated information accompanied by a suite of novel bioinformatics tools to assist biomedical research.
"For the past two years, Ardais and its partner medical institutions have focused on establishing the highest standards for every aspect of building and maintaining a national tissue library with informatics tools that can improve experimental research design in the post-genome age", noted Eric Gordon, Chief Executive Officer of Ardais Corporation. "As a result, we find that our activities are gaining broad and enthusiastic acceptance among patients, the medical and scientific communities, and the biopharmaceutical industry. We believe that the National Clinical Genomics Initiative is going to have a major impact on the productivity of drug discovery research and the future of health care, and we are extremely pleased that Maine Medical Center has joined with us in this effort."
The need for such an important research resource has never been greater. Recent discoveries have the scientific community moving rapidly towards potential breakthroughs in the diagnosis and treatment of many illnesses. For example, the genes involved with breast cancer, with certain forms of B-cell lymphoma, and with prostate cancer have been identified in experiments using human clinical samples. The National Clinical Genomics Initiative will facilitate such discoveries.
Susan Nesbitt, a cancer survivor who resides in Portland, commented: "Many cancer survivors are eager to participate in and support research efforts that may have a major future impact on the understanding and treatment of their disease." Her friend, Kirsten Potter of Portland, also a cancer survivor, added: "This Initiative represents a new and unique way to make a contribution."
Ardais and the participating institutions in the Initiative have set the highest ethical standards to protect the privacy and confidentiality of patient donors. Julien S. Murphy, Ph.D., Professor of Philosophy at the University of Southern Maine and a bio-ethicist, stated: "Based on my knowledge of this Initiative the key ethical issues have been well-addressed."
Ardais has pioneered a "double-firewall" model to ensure that patients are never identified by either the company or by researchers. Ardais and the collaborating institutions are complying with all existing federal and institutional requirements pertaining to the collection and use of clinical specimens and information, and have developed procedures and safeguards beyond what is required. Tissue donation by patients is completely voluntary, and does not affect clinical care in any way.
Maine Medical Center is a non-profit community hospital for the people of central and southern Maine, and is the premier tertiary care centre for northern New England. The hospital provides comprehensive inpatient services in all medical specialities. Centres of excellence are being developed in cancer care, heart care, children's services, and other areas building from existing excellence in multi-disciplinary services. MMC is also a teaching hospital, with active programmes in undergraduate, graduate and post-graduate medical education. Research, with emphasis on application to patient care, is an integral part of MMC.
Maine Medical Center is the premier heart care centre in Maine, providing a comprehensive range of services to treat heart disease and prevent its recurrence. The hospital and the many health care professionals who practise at MMC have dedicated themselves to constantly improving care, developing a continuum of services in the community, and taking part in pioneering clinical outcomes, cardiovascular disease, and cancer research.