News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Top-5 Diagnostics Trends Identified by Kalorama Will Impact In Vitro Diagnostics Manufacturers, Medical Laboratories in 2017

Report states IVD companies are focusing on core lab, seeking China FDA approval, and targeting urgent care

Several of the same powerful trends reshaping healthcare and clinical laboratory services are having equally significant influence on in vitro diagnostics (IVD) manufacturers. In particular, the consolidation of hospitals and physicians, as well as the emergence of new sites of service—such as urgent care centers and retail clinics—are motivating IVD companies to tailor new diagnostic systems to the unique needs of these entities.

Kalorama, a division of, has released its list of Top-Trends that will affect IVD developers in 2017. IVDs are at the heart of the medical laboratory industry. Thus, these reports are critical to keeping clinical laboratory managers and pathology groups informed on anything that could affect the production, voracity, and availability of diagnostic testing. (more…)

Somber Mood Prevails at Nation’s Largest Gathering of Laboratory Testing Professionals

AACC’s annual meeting still offers impressive array of scientific sessions and exhibits

Yesterday ended the 2009 Annual Meeting of the American Association of Clinical Chemistry (AACC) in Chicago, Illinois. Your Dark Daily team was there to ferret out anything new and interesting and to sniff out the latest trends in the business of laboratory testing.

As expected, this year’s event was considerably subdued. Attendance was clearly down, even though the exhibition hall featured more than 650 exhibitors—a number comparable to last year. But the exuberance of recent years was gone. For example, AACC did not make a public address announcement in the exhibit hall to announce the total number of attendees this year and thank everyone—at least not when your Dark Daily editor was in the exhibit hall. Speculation was that this year’s total attendance was down from the 20,000+ attendees in each of recent years. Estimates were that the attendance decline ranged from 20% to 30% fewer attendees.


Molecular Diagnostics News for Hospital Laboratories

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.”