When the Golden Gate Chapter of CLMA conducted its sixth annual Spring Fling conference at the Hotel Monaco in San Francisco, California, last Saturday, it offered an outstanding agenda for Bay Area lab managers.

Opening the conference was Robert L. Michel, Editor of The Dark Report and Dark Daily. Next on the podium was Alan Wu, Ph.D., who is the Director of Laboratories at San Francisco General Hospital, with a highly entertaining discussion of the role of forensic toxicology and his participation in several high-profile court cases over the past 15 years. He was followed by Rodney W. Forsman, Administrative Director of Outcomes at Mayo Medical Laboratories. Forsman’s remarks were the subject of your last Dark Daily briefing, Mayo Medical Lab Executive Highlights Market Opportunities for Hospital Laboratories.

The content of these presentations was excellent, and that was equally true of the next speaker, Ronald A. Blum, Ph.D., Director of Marketing for Specialty Laboratories. Blum spoke on the subject of molecular diagnostics and is uniquely qualified in this field. Since 1996, he has played in integral role at Specialty Laboratories in evaluating new molecular technologies and developing selected technologies for introduction into the clinical marketplace.

For community hospital labs, Blum had good news. First, he observed that molecular testing is the fastest-growing segment of the laboratory test menu, with growth rates of 15% to 20% annually. This compares with annual growth of about 5% for routine testing. Next, Blum discussed why the market segments for esoteric testing and anatomic pathology represent good opportunities for hospital laboratories. In both of these two segments, national laboratory companies do not dominate. According to Blum, about 50% of esoteric testing done in the United States is provided by regional and local laboratories. For anatomic pathology, approximately 79% of these services continue to be provided by regional and local laboratories. Thus, these markets have yet to be dominated by national laboratory companies.

While discussing the range of molecular tests, including target amplification, signal amplification, mass arrays, and the multiplex assay technology from Luminex Corporation, Blum singled out mass arrays for specific comment. “It is likely that mass arrays will be the most dynamic source of change in molecular testing,” observed Blum. “That is because a mass array can be designed to survey multiple locations across the entire genome. Mass arrays will offer an attractive combination of competitive costs, a degree of automation in looking at multiple markers, and the ability to highlight results that will be of highest interest to the clinician.”

Blum also observed that intellectual property and patent issues were making it increasingly difficult to package published research into clinically-useful molecular assays. “Since the 1990s, universities and research centers have become more active at protecting their discoveries by filing patents and have limited the licensing of their research,” he said. “As a result of this development, Specialty Laboratories hired its first full-time, in-house patent attorney last year, specifically to deal with intellectual property issues. But even more resources are needed to help us keep pace. We are actively looking to add a second full-time, in-house attorney to help with intellectual property issues.”

In closing, Blum was enthusiastic in his recommendation that community laboratories look for opportunities to establish a molecular diagnostics program. “First, aging baby boomers will create increased demand for health services. Second, emerging molecular tests give ever more precise diagnostic accuracy to clinicians. These are just two reasons why molecular diagnostics has a bright future,” declared Blum. “Local laboratories should evaluate their opportunities very carefully because of the high barriers to entry. One useful strategy is to partner with experts capable of helping your laboratory avoid pitfalls while developing an effective molecular diagnostics testing program.”