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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Frost & Sullivan Report Identifies Molecular Diagnostics as Fastest-Growing Sector of Clinical Pathology Laboratory Testing

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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Decisions in Prometheus, Myriad, and Classen Cases Help Clarify Patent Eligibility Requirements for Genetic Lab Tests and Molecular Diagnostics

Court rulings in several controversial patenting cases are largely consistent

Recent decisions from the U.S. Court of Appeals for the Federal Circuit (CAFC) offer some much-needed clarity in the controversial issues surrounding the legality of life sciences patents.

This will be of interest to pathologists and medical laboratory managers, because many clinical laboratories and pathology groups must pay royalties to patent-holders for rights to use the technologies. There are multiple legal cases winding their way through the federal court system, so legal decisions in these cases have the potential to change in status quo in patent law.

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Biomedical and Molecular Diagnostics Firms Compete To Hire Already-Scarce Medical Laboratory Technologists

In Silicon Valley, biotech and molecular companies “raid” hospital laboratories to hire away MTs and CLSs

Competition for already hard-to-find medical technologists (MT) and clinical laboratory scientists (CLS) is heating up as biomedical and molecular development companies vie with hospitals and medical laboratories for these highly-prized workers. Growth in demand for MTs and CLSs by biotech companies means that clinical laboratories will face stiff competition when recruiting and hiring for these positions.

This competition for hiring MTs and CLSs was recently the topic of a story in the San Francisco Business Times (SFBT). Molecular development companies in the Bay Area want to hire qualified clinical laboratory professionals. The demand pressure from this emerging sector is driving up wages and further stressing the capacity of underfunded job-training programs, according to the article. (more…)

NIH Plans To Create New Genetics Testing Registry of Molecular Diagnostics Tests Offered by Clinical Pathology Laboratories

Comprehensive genetic test database intended for use by pathologists, physicians, researchers and consumers


Pathologists and clinical laboratory managers will soon have a comprehensive registry of genetic tests that they can consult as needed. The National Institutes of Health (NIH) is creating a single public registry with detailed information about both genetic test providers and the 1,600+ genetic tests these providers offer.

The NIH believes the genetic test registry will bring greater transparency to the field. It hopes that the registry creates increased information-sharing about the different genetic tests which are available. Participation in the registry will be voluntary, though groups such as the Genetic Alliance have called for making it mandatory to help weed out what they call “the bad actors” in the industry.

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Molecular Diagnostics for Community Hospital Labs: Hitting Clinical and Financial Home Runs in Infectious Disease and Oncology Testing

How the implementation of molecular diagnostics can have a positive impact on patient care and financial growth

Dr Hosler

YOUR PRESENTERS:

Frederick L. Kiechle, MD, PhD, Medical Director, Clinical Pathology,
Pathology Consultants of South Broward, LLP

Kathleen M Murphy, PhD, Director of Clinical Laboratory Operations, ProPath

Gregory A. Hosler, MD, PhD, Pathologist, ProPath


LISTEN LIVE! AUGUST 25, 2010 at 1 PM EST


Molecular diagnostics are transforming the way your lab tests for infectious diseases and solid tumors. Increasingly, molecular tests supplement and often replace conventional diagnostic assays. They’re also being used to obtain prognostic data, and in some cases dictate therapy.

Molecular-based infectious disease assays enhance client/physician satisfaction by providing diagnostic information that yield quick results, making clinical decisions much easier. As a result, clinicians are increasingly asking for these tests.

Traditionally, pathologists have been the experts on diagnostic assays, helping physicians determine the most appropriate laboratory tests for their patients. But with the new assays being marketed directly to clinicians, they’re ordering tests themselves, bypassing the pathologist. As a result, pathologists are starting to see a reduction in their position as decision-maker when it comes to choosing the most appropriate tests.

As a pathologist, it’s critical that you stay current on the latest trends in molecular testing to preserve your role in patient management. Do you have the most current information on infectious disease testing? Are the new assays really faster and more accurate than conventional ones? How will you deal with the complexities and challenges of the new tests? And what are the benefits of these tests to both doctors and their patients?

Get the answers to these questions and more when you attend the latest Dark Report and DarkDaily.com audio conference “Molecular Diagnostics for Community Hospital Labs: Hitting Clinical and Financial Home Runs in Infectious Disease and Oncology Testing” on Wednesday, August 25, 2010. Listen as our panel provides details of the most commonly requested tests and offers insight into how to handle clinician requests for the new assays.

You’ll get details on the latest solid tumor molecular assays and find out what assays to expect in the future. Learn how to compare the different types of assays and determine when it’s appropriate to advise against a test, send tissue out, or bring a test in-house.

How do you decide which tests to perform in-house and which ones to outsource to other labs? Does it make sense for your lab to develop molecular diagnostics capabilities to detect infectious agents? Treatment decisions often can’t wait the 2-4 days that reference labs need to turn these tests around. So if faster results help you prevent more infections, doesn’t it make sense to do them in-house?

And of course it’s not only about the clinical benefits, which can be substantial. There are financial considerations as well. When a reference lab test is brought in-house, the cost savings can be significant. But there are additional expenses to consider. Find out how the implementation of infectious disease-based molecular diagnostics can have a positive impact on patient care and financial growth when you register to attend this very special event.

Let our experts show you how to ensure that your community hospital lab continues to be an invaluable resource that helps clinicians choose the right tests at the right time. Whether you’re a community-based pathologist, clinical lab director or hospital administrator, this is one session you can’t afford to miss.

THE DARK REPORT AUDIO CONFERENCE AT A GLANCE

DATE: Wednesday, August 25, 2010

TIME: 1 p.m. EDT; 12 p.m. CDT; 11 a.m. MDT; 10 a.m. PDT

PLACE: Your telephone or speakerphone

COST: $195 per dial-in site (unlimited attendance per site) through 8/13/10; $245 thereafter

TO REGISTER: Click here or call 1-800-560-6363 toll-free

For one low price-just $195 (through 8/13/10; $245 thereafter), you and your entire team can take part in this fast-paced, insightful audio conference. Best of all, you’ll be able to connect personally with our speakers when we open up the phone lines for live Q&A.

Here’s just some of what you’ll learn during this in-depth 90-minute conference:

  • The definition of a molecular assay and, in broad terms, a description of how they’re used.
  • The clinical value of rapid turnaround results for infectious disease molecular assays.
  • The solid tumor molecular diagnostics assays that are now considered routine.
  • The relationship between outreach client numbers and molecular test volume.
  • How cost avoidance can financially justify establishing MRSA and enterovirus molecular testing.
  • The financial outcome of bringing molecular assays from the reference lab to your local clinical lab.
  • The impact of genome patents on clinical molecular testing implementation.
  • How to evaluate send-out resources and decide when it’s right to use them.
  • The utility of some available proprietary molecular assays.
  • A comparison of FISH and amplification-based methods.
  • The equipment your lab needs to do molecular diagnostic testing.
  • A basic algorithm to help you decide when to bring a molecular diagnostic assay in house.

…and much more!

Your audio conference registration includes:

  • A site license to attend the conference (invite as many people as you can fit around your speakerphone at no extra charge)
  • A downloadable PowerPoint presentations from our speaker
  • A full transcript emailed to you soon after the conference
  • The opportunity to connect directly with the speaker during the audience Q&A session

Register Now! Or for more information, call us toll-free at 800-560-6363.

Distinguished Presenters:

Frederick L. Kiechle, MD, PhD has been the Medical Director of Clinical Pathology for the five-hospital (1792 beds) Memorial Healthcare System, working for Pathology Consultants of South Broward, LLP since 2006. The laboratory system performed 7.9 million tests in 2009. From 1988 to 2005 he was chairman of the Department of Clinical Pathology and from 1993 to 2005, the Medical Director of Beaumont Reference Laboratory at William Beaumont Hospital. That laboratory performed 6.5 million tests in 2004. Dr. Kiechle initiated molecular diagnostic testing and the annual William Beaumont Hospital DNA Symposium in 1991. He has directed basic research in signal transduction pathways in insulin action and apoptosis and has published extensively on the subject. Dr. Kiechle is the author of the best-selling laboratory management book, The Hitchhiker’s Guide to Improving Efficiency in the Clinical Laboratory, published by AACC Press, and co-editor of Molecular Diagnostics: Techniques and Applications for the Clinical Laboratory, published by Academic Press. He lectures internationally on basic research topics, point-of-care testing, automation, laboratory design, outreach program and molecular diagnostics.

Kathleen M Murphy, PhD is the Director of Clinical Laboratory Operations at ProPath. Her training includes a B.S. in Medical Technology from the University of Virginia, and a PhD from the University of Louisville. She completed post-graduate training in the Mid-Atlantic Cancer Genetics Network and the Molecular Pathology Fellowship at Johns Hopkins University. Prior to joining ProPath, Dr. Murphy was the Director of the Molecular Diagnostics Lab and an Associate Professor of Pathology and Oncology at Johns Hopkins University.

Gregory A. Hosler, MD, PhD is a practicing pathologist at ProPath. He specializes in dermatopathology and molecular pathology. His training includes a B.S. at Princeton University and an MD and PhD from The University of Texas Southwestern Medical Center. His PhD is in the field of immunology at the School of Biomedical Sciences. He completed his AP/CP Pathology residency training and dermatopathology fellowship at The Johns Hopkins Hospital. He holds the title of Clinical Assistant Professor at The University of Texas Southwestern Medical Center and works closely with Dr. Murphy at ProPath in the Molecular Diagnostics Division.

ACCENT® Continuing Education Credit
The American Association of Clinical Chemistry (AACC) designates this program for a maximum of 1.5 ACCENT® credit hours towards the AACC Clinical Chemist’s Recognition Award. AACC is an approved provider of continuing education for clinical laboratory scientists in the states of California, Florida, Louisiana, Montana, Nevada, North Dakota, Rhode Island, and West Virginia.


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