Jan 15, 2014 | Instruments & Equipment, Laboratory Hiring & Human Resources, Laboratory News, Laboratory Operations, Laboratory Pathology
Innovative web-based educational formats might add value to training initiatives for pathology residents and fellows and medical laboratory workers
In the final months of 2013, the regulatory fight between gene testing company 23andMe.com and the Food and Drug Administration (FDA) generated national headlines. In that encounter, 23andMe.com blinked and ceased offering health-related genetic tests to consumers.
However, the company continues to work to position itself as a major player in genetic testing and genetic medicine. In the second half of 2013, for example, 23andMe.com initiated a business campaign to position itself as a source of on-line information about genetics for educational purposes. (more…)
Jul 12, 2013 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Hiring & Human Resources, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Management & Operations
Departments of pathology and clinical laboratory medicine at nation’s academic medical centers are uniquely positioned to deliver value—but only if they act in a timely fashion
DATELINE: BOSTON, MASSACHUSETTS—Today the Association of Pathology Chairs (APC) concluded its annual meeting, and transformation of the U.S. healthcare systems was front and center as the topic of primary interest. This transformation presents pathology departments at the nation’s academic centers with a range of unique opportunities, along with some serious challenges.
On the upside, academic departments of pathology and clinical laboratory medicine are well positioned to be the leaders in clinical diagnostics that utilize the latest genetic knowledge and incorporate state-of-the-art molecular technologies. Not only are they teaching this knew knowledge to the next generation of physicians and pathologists, they are often the only locally based laboratory organization in a city or region that offers these advanced medical laboratory testing services. (more…)
Aug 6, 2012 | Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
23andMe executives want the credibility that FDA clearance provides for its DNA tests and declared their intent to eventually support more clinical laboratory test applications
Offering genetic tests directly to consumers is a controversial subject among some pathologists and healthcare ethics experts, who question both the science of these tests and whether consumers will do the right thing with the information.
Now that debate is likely to heat up, because direct-to-consumer genetic testing company 23andMe recently submitted an application to the Food & Drug Administration (FDA) to review and clear its personalized DNA test for market.
On July 30, 23andMe delivered its first round of 510(k) documentation to the FDA. This is a first for the direct-to-consumer genetic testing industry. At the same time, by seeking FDA clearance for its genetic tests, 23andMe will raise interesting issues for the traditional clinical laboratory testing profession. (more…)
Mar 19, 2012 | Laboratory Management and Operations, Laboratory Operations, Laboratory Pathology
Annual growth rates of 11% or more is predicted for molecular diagnostics in coming years
Just as consolidation and acquisitions reshaped the in vitro diagnostics (IVD) manufacturing industry and concentrated market share among just a handful of multi-billion dollar IVD giants, a similar consolidation can be seen in the molecular diagnostics sector. Today it is estimated that just nine global companies control 75% of the molecular diagnostics market.
That market concentration means clinical laboratories and anatomic pathology groups have a just a handful of primary vendors from which to purchase many of the molecular diagnostic assays and genetic tests that are used most frequently in clinical care.
Frost and Sullivan published a detailed study about the molecular diagnostics marketplace. The consulting firm estimated that worldwide sales of molecular diagnostics totaled $4.1 billion in 2010. By contrast, total IVD sales globally were about $48 billion in 2010. That total includes the routine, reference, and esoteric test kits, reagents, and supplies used every day by medical laboratories.
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Jan 25, 2012 | Laboratory News, Laboratory Pathology, News From Dark Daily
Genetic testing and molecular diagnostics will be essential to wider adoption of personalized medicine by nation’s physicians
MOUNTAIN VIEW, CALIFORNIA—Here in Silicon Valley at the Personalized Medicine World Conference (PMWC), the role of clinical laboratory testing and anatomic pathology services was consistently recognized as essential in advancing this important healthcare trend. Yet, at the same time, few pathologists or clinical laboratory executives were in attendance.
Your Dark Daily Editor, Robert L. Michel, was here at PMWC this week to speak on the topic of how medical laboratories and pathology groups will be one primary—and important—channel for helping physicians adopt and use personalized medicine in their medical practice. In simplest terms, it is typically pathologists and clinical laboratory professionals who educate doctors about the availability of new clinical lab tests and how to use them in their practice of medicine.
In that role, the medical laboratory provides physicians with information on when to order these new assays, how to interpret the lab test results, and how to use those results to determine the most appropriate therapy. Yet, here at the Personalized Medicine World Conference, developers at biotech companies seem to be overlooking this long-established fact in the clinical care marketplace. (more…)
