Jul 14, 2010 | Laboratory Instruments & Laboratory Equipment, Laboratory Pathology
New molecular point-of-care testing systems already being tested in several African countries
Pathologists will be interested to learn that sophisticated point-of-care molecular diagnostics testing is now being done on livestock in farms. This is a giant leap forward for point-of-care testing, as there are now commercially available suitcase-sized devices used to perform molecular diagnostic tests for avian flu in livestock. These molecular testing systems are undergoing trials in Africa, primarily Sudan and Kenya.
Development of the devices was partially funded through a joint project of the International Atomic Energy Agency (IAEA) and the Food and Agriculture Organization (FAO). The organizations are concerned about trans-boundary animal diseases that, like the avian flu, can cross from one species to another. These agencies funded research to develop molecular diagnostic methods to rapidly identify such diseases. The avian flu test is the first to make use of this new molecular technology.
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May 7, 2010 | Laboratory News, Laboratory Pathology
Medical technologists and clinical laboratory scientists will study the hottest new genetic technologies
There’s a new bachelor’s degree program in molecular diagnostics that will help expand the number of medical technologists (MT) and clinical laboratory scientists (CLS) available to work in the nation’s clinical pathology laboratories. The announcement was made last month by Ferris State University (FSU) in Big Rapids, Michigan.
“Continued growth in personalized medicine has created demand for practitioners with this skill set,” said Ellen Haneline, Dean of Ferris State’s College of Allied Health Sciences. “Combined with expansion on our local medical community, these factors were the impetus for establishing this cutting-edge degree program centered upon molecular diagnostics. This new degree will enable Ferris to become a recognized leader in providing clinical laboratory education and will particularly fill a need for this type of training in West Michigan.”
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May 2, 2007 | Laboratory Management and Operations, Laboratory News, Laboratory Operations
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.”
Mar 13, 2007 | Laboratory Management and Operations, Laboratory Pathology, News From Dark Daily
With each new advance in molecular diagnostics, local laboratories and pathology group practices find it easier to set up and offer molecular assays to their own clientele. That’s because newer generations of instruments automate steps and make it feasible to support this testing with a relatively small volume of specimens.
Challenges still remain, however. Payer coverage and reimbursement for many molecular assays remain inconsistent and unpredictable. In some cases, laboratories need technical skills which are either difficult to recruit or expensive to hire. Yet, where a molecular assay has clear clinical value, physicians want access to this test, particularly from a laboratory in their own community. It is this value added dimension to a molecular testing program which has helped a number of progressive pathology groups expand market share and revenue.
One such pathology group is ProPath of Dallas, Texas. With 30 pathologists, a cornerstone of its business strategy is to have subspecialist pathologists to serve its clients. Since the inception of molecular pathology, ProPath has reviewed new technologies and assays. It is willing to invest in three dimensions to bring up and offer specific molecular tests. It will acquire the instruments and equipment, it will hire or develop the technical expertise needed to run these tests and consult with physicians, and it will put money into a sales and marketing program to educate physicans and help them use these tests to the advantage of their patients. ProPath’s Executive Director, Krista Cruse, will present a case study at the upcoming Executive War College on Laboratory and Pathology Management and discuss ProPath’s success secrets in building a profitable molecular testing program.
To help both clinical laboratories and pathology group practices identify the best molecular testing opportunities for the marketplace they serve, Mary Steele Williams, COO & Director of Scientific Programs at the Association for Molecular Pathology, Bethesda, Maryland, will speak at the Executive War College specifically on the topic of which molecular assays are heading to market and likely to be both clinically useful to physicians and financially lucrative to the laboratories which offer such tests. In her role at the Association of Molecular Pathology, Williams gets a privileged look at emerging molecular assays, so her advice and insight can be invaluable for any laboratory wanting an insider’s view of today’s market for molecular testing.
Of course, The Dark Report has often written about the emerging business model in anatomic pathology that is now competing with local pathology groups for specimens. That is the specialty esoteric testing company. One of the most recent entrants into this category is RedPath Integrated Pathology of Pittsburgh, Pennsylvania. In the first 24 months of its business launch, it has grown to $5 million per year in revenues. RedPath’s innovation is patented technology that allows it to support both the diagnosis of cancer and the planning of treatment across multiple organ systems. The technology allows RedPath to work from a range of specimens, including traditional chemically-fixed slides, fluid aspirates, and cytology smears. Sydney F. Finkelstein, M.D., the pathologist who developed this technology and became RedPath’s founder, will be at the Executive War College to discuss how RedPath is giving community-hospital pathology groups additional molecular tools that they can use to add value to their client physicians.
As these examples demonstrate, molecular diagnostics and molecular pathology each can offer plenty of upside and opportunity for local laboratories and pathology groups. But there is also risk, because of unpredictable reimbursement and other factors. What is common to the laboratory case studies described above is that these pathology labs did careful market research. Lab directors and pathologists interested in developing a profitable, thriving molecular testing program should reserve a place at the upcoming Executive War College on May 10-11, 2007 in Miami. It’s an opportunity to meet Cruse, Williams, and Finkelstein and get first-hand access to their insights, advice, and recommendations.
PS: To get the latest news and effective strategies dealing with new trends, join us in Miami on May 10-11, 2007 for the 12th Annual Executive War College. You can access the full details using the links below. Take action today to reserve your place.
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Visit: http://www.executivewarcollege.com/
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1. Register ONLINE right now; or,
2. Call 512-264-7103. Our friendly staff can register you quickly and easily, as well as answer any questions you may have.
Apr 23, 2016 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
The laboratory industry’s forward thinkers define molecular diagnostics and genetic testing as both the future of pathology and the #1 opportunity to add clinical value while earning appropriate reimbursement.
Personalized medicine and predictive medicine have become a reality. As molecular technology and personalized medicine increasingly becomes the default position for clinical diagnostics laboratories, these modalities place significant demands on laboratory information systems. Although hospitals and healthcare institutions often focus on an electronic medical records system that includes a laboratory information system (LIS), those LIS’s do not typically have the functionality needed to handle current molecular testing needs, or needs expected in the near future.
DarkDaily.com is pleased to offer a recently published White Paper that discusses the trends in increasing use of genetic and molecular testing, the growth of big data in healthcare, and the challenges facing laboratories in handling the complexities of personalized medicine. (more…)
