As the story goes that I have heard a couple of versions of, somewhere in Florida in the early 1990s, a urologist or small group of urologists, taking advantage of exceptions in the Stark Law (actually there are multiple parts to this single law) and skirting anti-kickback regulations, started to perform anatomic pathology services and referring those specimens to their laboratories, or themselves.

Folks familiar with this recognize that Stark does allow self-referral of imaging or other diagnostic tests within the practice that is actually ordering or referring the patient for the test.  With passage of Obamacare, these groups are suppose to provide a letter to patients and inform them where else in the area these services may be available.  Kind of like a restaurant showing you a menu for 3 other restaurants after the restaurant manager referred you to his/her restaurant.  Not sure if this happens with any regularity.

Anyways, somewhere in Florida around 20 years ago, in-office pathology was born.

Throughout the 1990s, many urologists had supplemented their revenues through an arrangement with the maker of Lupron, a hormone drug for prostate cancer. Under the arrangement, Lupron producer TAPPharmaceutical Products Inc. sold urologists the drug at a steep discount, while the urologists in turn billed Medicare for the full price.

The arrangement ended in 2001 when several urologists were indicted and TAP Pharmaceutical paid more than $840 million to settle a Justice Department investigation. Deprived of the Lupron profits, some urologists' incomes declined by as much as one-half according to accounts by urologists at that time.  

It is thought that declining reimbursements from Lupron that eventually ended in 2001 led at least in part to urologists looking for other sources of revenue.

According to their website, In-Office Pathology was formed in 2004. The site mentions over 45 installations in eighteen states in urology, gastroenterology, dermatology and multispecialty practices. This company also claims "We do it better than anyone else". Laboratory Economics reviews this regularly and almost every issue contains new physician owned laboratories within urology, GI and dermatology

Recently, as I mentioned earlier this week in a post on over utilization within in-office pathology laboratories, in what may come to be called The Mitchell Report (OK, the Other Mitchell Report), a study published by Dr. Jean MItchell, a noted Geogetown economist confirmed with a multi-year study of such practices an increasing number of biopsies with actually fewer cases of prostate cancer detected by those practices. 

Besides from perhaps doing more rather than less and violating the principle of "first do no harm" fewer diagnosed cases of prostate cancer also hurts their referral rate to their specialized IMRT centers for treatment but that is for another post on another day...

Since the article on this topic was published that American Urologic Association wrote a letter to the editor in the journal the article appeared in referencing a "turf war" and claiming over the past decade the number of jars for best clinical practices increased from 6 to 12, with one biopsy in each jar.  This translates to 12 CPT codes (88305) for the referring physician who will capture the technical and professional component within his/her respective self-owned laboratory.

For more on this story and a copy of the AUA's response and response from In-Office Pathology check out The Pathology Blawg for continuing coverage of the story.

So, what does any of this have to do with digital pathology?  A lot.

I can't really say that I have a horse in this race or any "turf" worth getting into a war over in my practice per se.  This freight train left the station years ago and I do not begrudge IOL, the urology community or pathologists who are employees or part-owners of these laboratories for trying to make a buck, if done correctly and in accordance with best clinical practices.

One of the real problems here is that the technology to process tissue has become so good one can have a tabletop tissue processor, small stainer and coverslipper and IOP with 350 square feet of office space, some drywall and nails and create a full-service anatomic pathology laboratory. I bet it would be hard to find any of the laboratory information system companies geared toward the outreach/outpatient market who does not have at least one install in an operation such as this.  

This is a perfect market for digital pathology.  You could create the possibilty to have a team of prostate experts review cases remote from the provider, patient and histology lab and report those findings with web-based LIS systems.  For straight TC/PC relationships this would work fine where everyone gets paid for what they are doing.  Save the urology or GI group the cost of a pathologist plus additional coverage when that person is attending a prostate pathology meeting or on vacation.

Whole slide imaging could augment the laboratory or completely eliminate the need for pathologists to be onsite beyond some basic medical director functions. Of course the idea here is that some of these urologists and gastroenterologists would want the full global charge capability rather than outsourcing the professional component.  Perhaps if they hire the wrong pathologist they might re-think this model as well.

Here is an idea, I can do a one-year endoscopy fellowship for upper and lower GIs, set up an endoscopy center complete with the latest state of the art endoscopes, build a lab in the back of the practice, do my own biospies and read my own biopsies.  Would anyone have a problem with that? I saw the patient, I did the gross examination via endoscopy and can correlate it with the slides.  Perfect. It turns out that the CPT codes and reimbursements for upper or lower GI endoscopy with biopsy is higher than a UGI or LGI examination without biopsy. Even better. And because it is an invasive procedure, I should take more rather than fewer biopsies to diagnose disease. None of this of course would be driven by financial reasons.  It is all evidence-based and presumably my rates of disease detection would go up or I would consider doing fewer biopsies over the course of time (certainly within 3-5 years) if the yield is no greater (or lower) than a control group (self-referring vs. refer to AP lab).

Cirdan Imaging, a new name in digital pathology, is developing new low-cost digital pathology solutions to improve workflow within the laboratory.

We would like to build up a detailed picture of what digital pathology techniques have been implemented in the laboratory and to determine how far these have penetrated into day-to-day operations.

If you are working anywhere within the pathology laboratory environment or have an interest in new digital pathology techniques, we would appreciate your comments.

You can enter our survey at:

https://www.surveymonkey.com/s/cirdanimaging

The full results of the survey will be available and will be circulated to all respondents. The respondents will also have the opportunity to be entered into a draw for an new iPad.

The Proportionator principle is a significant advance for stereology as a discipline, which will allow scientists to implement stereological study designs also in high-throughput environments. 

Hoersholm, Denmark - April 11, 2012 - Visiopharm A/S, a global leader in Quantitative Digital Pathology, announced today that the European Patent Office has issued the European Patent No. EP 2102817, entitled: Proportionator. 

“With the new Proportionator principle, we have demonstrated a several fold increase in efficiency, when compared to traditional Systematic Uniform Random Sampling”, says Prof. Jens Randel Nyengaard. 

Stereology is a method that allows scientists to answer important research questions about the total amount of microstructure in a tissue volume, including at the organ level; and provide statistically unbiased answers with a known precision. Examples are number of cells, trabeculae, alveoli, and other objects. Also total volume, surface area and total length of structures in an organ are examples of what can reliably be quantified. Stereology is the only way to achieve accurate quantitative data about such tissue properties with a known precision. 

Scientific communities and regulators with a genuine concern about the validity of quantitative histomorphometric data are increasingly requesting stereological data, or at least evidence that such data is concordant with an appropriate stereological reference. Stereology is now becoming a critical component for a useful Quantitative Digital Pathology platform; and a technical discipline that research professionals with a need to study tissue properties can no longer afford to ignore. 

With classical stereological methods and tools, implemented on traditional microscope systems, it is time consuming, repetitive, and costly work to produce stereological data. Typically, service requirements for complex microscope systems are not trivial. Until recently, there were no good alternatives. 

Since 2004, when Visiopharm took over the highly respected CAST™ stereology technology developed by Prof. Gundersen, Visiopharm® has invested massively in the development of innovative and efficient stereological techniques and research tools, in close collaboration with the world-leading stereologists at the Stereological Research Laboratory in Aarhus, Denmark. The result is newCAST™ and a patented set of tools and techniques that efficiently overcome the bottlenecks of classical stereology. 

The Proportionator™ is the latest addition to this toolbox and a revolutionary stereological sampling principle that allows image analysis to guide the sampling of fields, while still providing statistically unbiased results, which is the hallmark of stereological methods. The Proportionator™ was co-developed with the Stereological Research Laboratory in Aarhus, Denmark, which remains the leading innovators and practitioners of stereology, and are the founders of modern design-based stereology. 

Says Prof. Jens Randel Nyengaard, “With the new Proportionator principle, we have demonstrated a several fold increase in efficiency when compared to traditional Systematic Uniform Random Sampling. This is a significant advance for stereology as a discipline, and will allow scientists to implement stereological study designs also in high-throughput environments”. 

Johan Doré, CTO at Visiopharm adds “We see this new patent as an important addition to our Automated Physical Disector patent, which has already made Whole Slide Stereology extremely efficient by automatically aligning serial tissue sections and sampling perfectly aligned disector pairs. Powering this technology with the Proportionator will further enhance the efficiency, saving users countless hours of repetitive work, and providing quality results with very high precision. We believe that the combination of Whole Slide Imaging with automation of stereology is the key to successful implementation of stereology in life-science research”. 

“In order to become successful with stereology, it is important to understand that a complete stereology solution is more than a few standard techniques implemented in a software program. It is critical to have a firm grasp of all steps from tissue sampling over Field Of View sampling to counting and reporting of results. Without access to competent application support, the transition can sometimes be a painful and expensive experience for adopters. For almost a decade, Visiopharm have invested significantly in innovation, development, practical work, and people with the right skill-set; and we are developing our technology in close collaboration with the world-leading stereologists from the Stereological Research Lab in Aarhus. This is giving our customers the certainty and comfort that we are able bring them safely all the way through an important and very rewarding transformation, which is in some ways quite radical”, says Michael Grunkin, CEO of Visiopharm. 

The latest example of how Whole Slide Stereology is applied, using AutodisectorTM and ProportionatorTM, is offered in our Webinar on: “The application of whole slide stereology for cost effective assessment of beta cell changes”, on April 12, 2012m by Jacob Jelsing, MSc, PhD, and CSO from Gubra ApS. 

About Visiopharm Over the past 10 years, Visiopharm image analysis and stereology software has become the preferred Quantitative Digital Pathology solution for leading biopharmaceutical companies, clinical researchers, and academic researchers all over the world. Visiopharm has more than 300 deployed systems worldwide and a large network of distribution and support partners, and is featured in over 400 scientific publications. 

Last month ASCP Press published a new book on pathology informatics, the first multi-authored textbook on the subject geared towards a comprehensive review of the field of pathology informatics.  

Drs. Pantanowitz (UPMC), Weinstein (U of Arizona) and myself have a chapter devoted to telepathology and whole slide imaging.  

A must read (at a great price) for resident or practicing pathologist alike as well as anyone with interests in the diverse nature of pathology informatics for practical management, operations, budgeting and project planning.

Editors:

Liron Pantanowitz, MD
J. Mark Tuthill, MD
Ulysses G.J. Balis, MD

Description:

Order#5831 | ISBN:9780891895831

Pathology Informatics: Theory & Practice is the first multi-authored, current and comprehensive compendium of the diverse and rapidly expanding field of pathology informatics.

It includes all of the critical and practical advice for management, operations, budgeting, and project planning and will serve as a comprehensive review of the field for students, pathologists, and laboratory professionals. This book deals with the role of computing hardware, software and databases involved in the efficient information management for pathology practice, as well as the fundamental science of informatics that is so deeply embedded in this subspecialty.

The text builds from basic principles of computer theory to more sophisticated informatics concepts.

• Databases and data mining; networks and workstations; system interfaces and interoperability. 

• Bioinformatics, imaging informatics, clinical informatics, and public health informatics. 

• Automation and middleware that facilitate complex workflows encountered in both anatomic and clinical pathology practice. 

• Molecular testing and point of care solutions. 

• Coding and nomenclature. 

• Standards in Laboratory Information Systems (LIS) and imaging systems. 

• Project management and business skills. 

• Pathology reporting. 

• Electronic medical records. 

• Specimen tracking and identification. 

• Error reduction and quality management. 

• Training and education in pathology informatics.

Hardbound • 336 pages • 112 figures • 368 tables

List Price: $135.00

Member Price: $105.00

A CAP Statline from yesterday I saw on another blog mentions that an independent study shows the first clear evidence of self-referral of anatomic pathology services leads to increased utilization as well as higher Medicare spending and lower rates of cancer detection.

For CAP members, there will be a special webinar on the topic end of this week (see below for details).

This is a topic that any pathologist who is aware of anatomic pathology services being insourced, or "brought in house" by clinicians, referred to as in-office labs (IOLs) or POD labs, has suspected for as long as the practice has been in place.  The idea that perhaps some, if not all, of urologist IOLs or POD labs, and let's for the sake of argument, just say that is a minority of labs doing so, perform more testing, bill Medicare more, but do not increase their yield of cancer detection beyond conventional means of doing so with fewer tests wil come as no surprise to practicing pathologists aware of some of these practices at least.

At first glance it does not appear that the study looked at excess immunohistochemical stains that may be performed without providing clinically relevant information.  It looks like without more complete reading of the study design and findings that the author looked at number of biopsies inasmuch as additonal ancillary studies.  Nonetheless, it is a form of overutilization whether you look at number of biopsies or cups or stains, particularly if doing more biopsies does not increase the yield of cancer detection.

This is however a sensitive issue as pathologists are also physicians who own and/or operate laboratories where additional testing may also provide some financial incentives without necessarily being in the bests interests of patient care.  And pathologists can also self-refer vis-a-vis immunohistochemical stains, special histochemistry stains or perhaps molecular tests that are not needed, indicated or non-contributory in terms of diagnosis, treatment and management.

Do we reallly need to perform Alcian blue stains on every esophageal biopsy to insure we do not miss intestinal metaplasia?  Are Giemsa stains terribly helpful on every stomach biopsy? Some will claim their clinicians request these for these types of specimens and so they do it.  It reminds me of taking a "shotgun" approach with immunohistochemistry illustrated in this video.  Make sure to order the vimentin stain.  A negative or positive result among the other 26 stains will help to cinch the diagnosis and by doing them at once, despite not using the H&E morphology as a guide, will surely lead the right diagnosis quicker and more accurately without any prejudice to perhaps just doing a few fewer stains which will provide the same result with the correct diagnosis. 

I was saw a case in referral of a liver biopsy from an elderly gentlemen with biopsy proven colon cancer processed at the same lab and read by the same pathologist who was interpreting the liver biopsy.  The H&E appearance on the liver biopsy was identical to the colon cancer from the biopsy of that a week prior.  This, however, not to be undone and believing no case is complete unless the requisite number of immunostains are done, ordered 18 immunohistochemical stains on the liver biopsy.  18.  For a routine, typical, colon cancer metastatic to liver, of course metastatic at the time of the initial biopsy a week prior. The patient was seen at our institution for treatment.  The H&E of the liver biopsy and the H&E of the colon biopsy were likely all that would have been needed.  The CK20 and CDX-2 stain were confirmatory and the other stains, including MUC antigens I did not know existed, help proved, in case there was any doubt, that this was not likely a brain, lung, kidney, liver, pancreas, testicular, prostate, bladder or gallbladder primary metastatic to the liver.

The point is the urologists with the labs, specifically those in this study to be clear and without knowing specifically who they are, are not the first physicians/lab directors to come up with this or take advantage of the ability to self-refer on lab specimens within their shop.  

As a pathologist, we should applaud CAP's efforts on this issue in providing sound data to illustrate the iappropriate clinical business practices but we should also as a specialty be mindful of what is appropriate as well in our own laboratories if we are going to claim these in-office labs are conducting themselves inappropriately.

Perhaps this could be the start of removing anatomic pathology services from the exception on the Stark Law but we must also set clear examples of appropriate use of ancillary tests.

April 9—Self-referring urologists billed Medicare for nearly 75% more anatomic pathology (AP) specimens compared to non self-referring physicians, according to a study published today in a leading health care policy journal. Furthermore, the study found no increase in cancer detection for the patients of self-referring physicians—in fact, the detection rate was 14% lower than that of non self-referring physicians.

These findings, from an independent study co-funded by the CAP, provide the first clear evidence that self-referral of anatomic pathology services leads to increased utilization, higher Medicare spending, and lower rates of cancer detection. The study, led by renowned Georgetown University health care economist Jean Mitchell, PhD, will appear in the April 2012 issue of Health Affairs and is now available on the journal’s website.

“The findings are irrefutable,” said CAP President Stanley J. Robboy MD, FCAP. “The Mitchell study raises a red flag on self-referral, giving evidence that it tends to increase utilization and cost with little or no patient benefit.”

This analysis also supports the College’s long-standing position that self-referral of anatomic pathology services needs to end by removing anatomic pathology from the exception in the Stark Law.

“We need to close a loophole in the law to prevent anatomic pathology from being referred to labs where referring physicians have a financial self interest,” said Dr. Robboy.

• Watch and listen to the study’s author, noted Georgetown economist Dr. Jean Mitchell in a special CAP members-only Webinar this Friday, April 13, 1:30pm-2:30pm EST. Register online.
• Read the full article on the Health Affairs website, and more details in this week’s Statline.
• Visit the new Self-Referral Resource Center on the Advocacy website for more on the study and CAP’s efforts to stop self-referral of anatomic pathology testing services.

PathXL is working alongside The Royal College of Pathologists to coordinate a pilot project with the aim of exploring the benefits and usage requirements of Digital Pathology by College fellows.

Other objectives include investigating whether the College should create an archive of slides in support of e-learning.

PathXL, a global pioneer in the use of web-based solutions for digital pathology, is providing the image and content management software as well as secure cloud hosting for the pilot. With PathXL, slides can be accessed from any location, including within NHS firewalls. Slide management tasks can also be conducted from any location.

There are two digital scanners installed at the College – one fromNikon /Hamamatsu and the other from Laser 2000/3D Histech. The equipment is available for fellows to use and test, and is located in the Fellows room on the first floor of 2 Carlton House Terrace.

All fellows are welcome and encouraged to use the equipment to scan slides and to comment on the suitability of the equipment and the results generated. A short evaluation form has been designed to capture feedback from users and this important feedback will be used to write a report at the end of the pilot for consideration by Council.

The pilot will run until 6th May – to book a particular time slot please contact the front of house team on scanning@rcpath.org or telephone 020 7451 6707. All of the front of house staff have been trained to use the scanners and software and will be available to help out if required.

For more information please visit http://www.rcpath.org/

GE Healthcare adds to its medical diagnostics business with additional sequencing and next generation technologies.  

In a few years it is entirely conceivable all of one's healthcare from cradle to grave will be supplied by a few providers for technical services.  From the amniocentesis to imaging your broken bones in childhood, to personalizing your colon, breast, lung or colon cancer and then the directed therapy to treat such cancer, could all be provided for by the likes of GE or Roche or another multi-national health services technology and treatment provider with personalized diagnoses, companion diagnostics, imaging and therapy.  

Addition of high growth company builds on Clarient’s biopharma service capabilities and provides platform to offer sequencing-based clinical diagnostics in the future

St Giles,UK – 4 April 2012 – GE Healthcare, a unit of GE (NYSE: GE) announced today that it has acquired SeqWright, Inc., a provider of nucleic acid sequencing and other genomic services.  The acquisition adds complementary genomics capabilities to Clarient, a unit of GE Healthcare and a leader in the fast-growing molecular diagnostics sector. The deal also provides a platform for Clarient to expand its clinical diagnostic offerings to include next generation sequencing. Financial terms of the acquisition were not disclosed.

“Understanding how genetic variation at the molecular level impacts disease is critical in the continued discovery and development of new and more effective therapies, and increasingly in the management of patient care through the use of more precise diagnostic tests,” said Pascale Witz, President and CEO, GE Healthcare, Medical Diagnostics.  “Combining the expertise and capabilities of the two companies will enable GE Healthcare to offer a substantially wider range of services to the biopharmaceutical, diagnostic and research industries and eventually to patients and health care providers.”

Molecular diagnostics provide precise information about a patient’s disease and can help doctors decide on the best treatment.  The rapid increase in the incidence of cancer worldwide, together with advances in specific cancer-focused therapies, is driving significant demand for molecular diagnostics. 

“As a CLIA-certified service provider, we are in a position to capitalize on the growing role next- and third -generation DNA sequencing technologies will play in clinical diagnostics,” said Fei Lu, President and CEO of SeqWright. “This partnership will put us in a position to apply the power of new direct detection technologies to clinical and companion diagnostics, potentially revolutionizing the way healthcare decisions are made. 

As biopharma companies continue to develop large portfolios of increasingly targeted therapies, the need for fast, accurate and cost effective sequencing technologies and services to determine the genetic profile of patient samples becomes vital to clinical trials and the development of companion diagnostics.  SeqWright has an extensive history of projects that focus on clinical trial and regulatory support for companion diagnostic submissions. The complementary capabilities of Clarient & SeqWright will allow the combined business to add immediate incremental value to existing pharmaceutical and biotechnology partnerships throughout their drug development and companion diagnostic development efforts. 

“Sequencing, including next-generation DNA sequencing, is an important technology for GE’s medical diagnostics business,” said Carrie Eglinton-Manner, CEO of Clarient.  “The acquisition of a specialized laboratory with long-standing expertise in the sequencing field as well as an established customer base allows us immediate entry into this high-growth space, and is an ideal complement to Clarient’s existing protein and gene expression profiling in support of pharmaceutical and in vitro diagnostic studies.”

Clarient provides pathologists and oncologists with access to diagnostic tests that shed light on the complex nature of various cancers by combining innovative diagnostic technologies with pathology expertise to assess and characterize cancer.  Clarient is focused on developing novel, proprietary diagnostic markers and tests for the profiling of breast, lung, colon, melanoma and blood-based cancers, to help clinicians make informed decisions on how best to treat their patients.  Given the increasing importance of more targeted cancer diagnostics, Clarient is well positioned to bring differentiated, added-value molecular diagnostic products and services to market.  Since 2007, Clarient’s revenues have grown at an approximate 30 percent compounded annual growth rate.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality around the world. Headquartered in the United Kingdom, GE Healthcare is a unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employees are committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our web site at http://www.gehealthcare.com.

For our latest news, please visit http://newsroom.gehealthcare.com

About SeqWright, Inc. 

Founded in 1994, SeqWright, Inc. is a full-service nucleic acid technology contract research organization focused primarily on traditional and next-generation nucleic acid sequencing.  SeqWright is CLIA certified and GLP compliant, enabling the company to offer services in support of product regulatory submissions.  With over 17 years of genomics experience, SeqWright has built a reputation for quality, technical expertise and a willingness to customize services to meet its customers' individual needs.  The company’s mission is to drive scientific and medical innovation by helping to facilitate and accelerate the research and development efforts of its customers. 

SeqWright is based in Houston, Texas and employs approximately 34 people. For more information, please visit the company’s website at http://www.seqwright.com

MOUNTAIN VIEW, Calif., April 4, 2012 /PRNewswire/ -- Since the inception of the market in 1998 and until 2008, revenue from the North American computer aided detection and diagnosis (CAD) market continued to grow rapidly year over year. It surpassed the $100 million mark for the first time in 2007. However, this upward trend was reversed in 2009 due to several factors affecting global healthcare. Once confined to image analysis and pattern recognition algorithms, CAD solutions have expanded dramatically in recent years to provide more workflow management functions for the diseases and conditions they cover.

New analysis from Frost & Sullivan's (http://www.medicalimaging.frost.com) North American Market for Computer-aided Detection and Diagnosis research finds that the market earned revenue of $103.5 million in 2010 and estimates this to reach$181.7 million in 2017.

If you are interested in more information on this research, please send an email to Britni Myers, Corporate Communications, atbritni.myers@frost.com, with your full name, company name, job title, telephone number, company email address, company Web site, city, state and country.

"From CAD solutions used on the spot, some have evolved into computer-assisted decision-making solutions or computer-assisted pre-surgical assessment solutions, whereby they provide more of an end-to-end solution used prior, during and after treatment or surgery and for accessing databases for clinical decision support," said Frost & Sullivan Principal Analyst Nadim Daher. "Applications such as prostate treatment or liver transplantation will drive CAD from a mere detection and diagnosis tool to a more complete solution providing image based analytics, disease quantification, treatment assessment, and workflow management."

Regardless of the unfavorable market conditions prevailing in North America since 2008, CAD industry participants have continued to fuel their R&D efforts and expand their product portfolio. As a result, the market is slowly starting to move towards multi-modality solutions, a trend that is poised to broaden market appeal of CAD through numerous sales channels.

Reimbursement is a key element in the business model for CAD purchases. The profitability of medical imaging service lines is being challenged as reimbursement rates for procedures continue to fall at the rate of a few percentage points annually due to various Medicare reimbursement cuts and healthcare reforms. In this tough economic landscape, it becomes difficult for clinicians to justify the extra cost that CAD adds to imaging procedures, without a clear financial return.

The business case for CAD becomes more challenging within, as well as outside, mammography. As for its clinical case, it is balanced by greater clinical acceptance on one hand, and slowing technology innovation on the other.

In light of the U.S. Food and Drug Administration (FDA) draft guidance documents for CAD technology issued in October 2009, CAD vendors are facing a toughening regulatory environment and, as a result, will be slower in bringing CAD innovation to the marketplace.

"Despite imaging providers' budgets starting to free up during the latter part of 2010, CAD has not been in the best position to return to its historical double-digit growth rates," said Daher. "Current market dynamics suggest that the market will continue upon a steady, but not explosive, growth path."

A careful analysis of the clinical benefits, the impact on workflow, and the return on investment (ROI) of CAD solutions will be crucial for CAD vendors to drive more favorable purchasing decisions within a widening addressable marketplace. This market reality calls for greater customer education efforts from the vendors about CAD, as well as more effective communication and collaboration with existing and prospective customers.

North American Market for Computer-aided Detection and Diagnosis is part of the Advanced Medical Technologies Growth Partnership Service program, which also includes research in the following markets: Cloud Computing in Medical Imaging (Vital Signs); Molecular Imaging Equipment (PET, SPECT, and Hybrid Systems); Computer Aided Detection and Diagnosis; Healthcare Reform and Medical Imaging (Vital Signs); Cardiovascular Image and Information Management Systems; U.S. Core Modality Market Update: CT, MRI, DR/CR, Fusion Imaging (Vital Signs); Digital Pathology Image Management Systems; Personalized Medicine (Vital Signs); and Medical Ultrasound Imaging Equipment. All research services included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.

About Frost & Sullivan
Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best-in-class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best-practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages 50 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 40 offices on six continents. To join our Growth Partnership, please visithttp://www.frost.com.

“The International Healthcare Social Media & Web 2.0 Conference”

• NEW: EARLY BIRD III EXTENDED UNTIL APRIL 10, 2012! Sign-Up Now!
  

• Sample our Testimonials   Angel Gonzalez ”my sincere message of congratulations for all of  your effort on bringing to life this special conference that, for me, has got the category of ‘Gold-Standard’ in Health 2.0!”  Giovanna Marsico ”I recommend this rendez-vous in Paris as the major event in Europe for all people interested in Health and Medicine 2.0 and Social Media.”  Berci Mesko  “Doctors 2.0 and You 2011 in Paris was THE medical social media conference of the year and I can’t even imagine how great the next event will be with more participants with even more topics covered. I look forward to speaking there and I encourage everyone from pharma to patient groups and doctors to participate in these discussions.”  Pedro Pinto ”…pragmatic shared experiences, excellent network and great business opportunities… we are now involved in a vibrant and collaborative community of people who really want to make things change. Congratulations for this excellent work!”  

•  See Doctors 2.0 & You Press Releases in: English, French, Spanish, Italian, German, Dutch

• Join the Manifesto Authors. How about you?

Producers/Organizers

Basil Strategies Team is delighted to prepare this exciting event. See the Basil Strategies team page.

What is Doctors 2.0™ & You?

The second edition of the must-attend annual health care social media conference in Paris ; the only international congress devoted to the understanding of how physicians use New Technologies, Web 2.0 tools, Social Media to communicate with other health care professionals, patients, payers, pharmaceutical companies, public agencies…

Who should participate?

Those who decide on and or benefit from e-services to physicians : professional and patient associations, pharmaceutical companies, governments, payors.
Who within these organizations is concerned? Program organizers, strategists, trainers, communicators, marketing professionals and IT specialists.
Please note that physicians practicing in France will benefit from CPD credit by attending this conference.

When / Where?

May 23-24 2012 in the City of Lights – Paris! The conference will take place at Cité Universitaire in Paris (to know more, click here). There will also be an amazing Cocktail Soirée on the 23rd, taking place at at an exclusive location to be announced soon!

Why?

Doctors 2.0™ & You will again be THE conference on this subject in 2012. You will meet the stars of Web 2.0 and Social Media for Health Care and Medicine. You will get a special look at the impact of the latest technologies on the relation between physicians and patients, colleagues, industry, the public sector. And maybe, just maybe,  you might win one of the contest’s prizes.

Meet our Advisory Board

Doctors 2.0™ & You is supported by the combined effort of Basil Strategies and the Advisory Team which include: (Austria) Michaela Endemann, (Canada) Pat Rich, (France) Catherine Cerisey, Alain Clergeot, Raphaëlle Laubie, (Germany) Alex Schachinger, Len Starnes, (Greece) Kathi Apostolidis, (Hungary) Berci Mesko, (Israel) Yossi Bahagon, (Italy) Roberto Ascione, Giovanna Marsico, (Netherlands) Janine Budding, Rob Halkes, (Spain) Jorge Juan Fernandez Garcia, Angel Gonzalez, (Switzerland) Silja Chouquet, (UK) Felix Jackson, (USA) Larry Chu, John Mack and Lawrence Sherman. For more information about the Advisory Board, please visit the Board of Advisors 2012 page.

By hosting the human genetics catalog in the cloud, AWS gives researchers instant access to the complete 1000 Genomes Project on AWS, enabling scientists to accelerate disease research.

This morning Leica announced the release of a new image analysis application desgined to integrate with their portfolio of the SCN400 scanner and Ariol technology.  Was able to get a sneak peek at this application recently and was impressed with ease of use and accuracy embedded within a complete digital pathology solution from scanning to archiving to viewing to image analysis.  

As frequent readers know, I consider image analysis a significant component of digital pathology.  The technology takes pathology to a place we have not enjoyed with conventional microscopy and often single stains on a single slides, usually immunohistochemistry-only or flourescent-stain alone.  

While effective, it limits interpretation largely to tumor biology rather than cellular biology. Image analysis allows for deconvoluting multiplex staining to ask very specific questions about particular cellular phenotypes rather than tumor phenotypes, and in return, answer some specific questions related to celliular behavior, clinical prognosis & enhance biomarker development and drug discovery.

Lessons learned from the HER2 experience, related therapy and known issues with processing, staining and interpretation I think have shown the need for image analysis for improved accuracy, consistency and reproducibility.

Wetzlar, Germany, March 30, 2012—Leica Microsystems announces the release of Tissue IA 2.0, high performance image analysis for discovery research. Combining fluorescence and brightfield analysis capabilities in a single platform, with precision cell modelling, Tissue IA 2.0 offers a superior solution for IHC biomarker quantification. Tissue IA 2.0 joins the Total Digital Pathology portfolio from Leica, providing streamlined end-to-end excellence in capture, management and analysis of digital pathology images.

A major challenge in research today is retrieval of quantitative, reproducible data from tissue-based IHC studies. Tissue IA 2.0 provides expert tools for researchers to extract the most from their studies. Powerful color separation and multi-marker colocalization functionality provides advanced insight and unbiased measurement of multiple antigen immunostaining in brightfield or fluorescent samples. Sophisticated cell modelling accurately detects and quantifies differential expression of staining in cellular compartments, providing detailed insight into cytoplasmic, membrane and nuclear biomarker localization.

The advanced dual staining capabilities in Tissue IA 2.0 enable researchers to identify cell cohorts at the molecular level.  Use one marker to identify a population of interest and then quantify expression of a second, providing exceptional analysis performance and greater understanding of a user’s slides.  Algorithms are easily adjusted and optimized for different markers, tissue and protocols giving a flexible platform for drug discovery applications. 

Easy to deploy and easy to use, the Tissue IA web-accessible interface means that users can take their analysis with them wherever they go. With high throughput batch analysis capacity, Tissue IA 2.0 will process whole slides, regions of interest or tissue microarray cores, and automatically integrate analysis results with a user’s slides. A built-in upload interface facilitating integration of algorithms from 3rd party software solutions, gives greater flexibility to further expand analysis options.

Dr. Donal O’Shea, Head of Digital Pathology in Leica Microsystems, says:

“Mulitplexing is of growing importance in translational research and tools to help quantify the expression and location of multiple biomarkers concurrently in tissue are a real requirement.  TissueIA 2.0 delivers for the user through offering chromogenic and fluorescence quantification and co-localization, cell based histoscoring on multi-compartmental IHC staining and the power to include and exclude cell populations based on biomarker expression.  In conjunction with our SCN400 F and Ariol platforms, this further expands our Digital Pathology portfolio for the life science and clinical researcher and demonstrates our ongoing commitment to this area.”

Tissue IA 2.0, with its powerful, streamlined analysis, is the ideal choice for biomarker discovery and translational research. Its unique combination of flexibility, automation and ease-of-use make it an unparalleled tool for digital pathology research. To learn more about Tissue IA 2.0, please visit http://www.leica-microsystems.com/products/digital-pathology/analyze/details/product/tissue-ia/

Leica Microsystems will be at the American Association for Cancer Research Annual Meeting 2012, March 31 – April 4, Chicago, IL. Visit Leica at booth 4103 to experience our new image analysis solution for Digital Pathology.

*For research use only. Not for use in diagnostic procedures.

About Leica Microsystems

Leica Microsystems is a leading global designer and producer of innovative, high-tech, precision optical systems for the analysis of microstructures. It is one of the market leaders in each of its business areas: Microscopy, Confocal Laser Scanning Microscopy with corresponding Imaging Systems, Specimen Preparation, and Medical Equipment. The company manufactures a broad range of products for numerous applications requiring microscopic imaging, measurement, and analysis. It also offers system solutions for life science including biotechnology and medicine, research and development of raw materials, and industrial quality assurance. The company is represented in over 100 countries with 16 manufacturing facilities in 9 countries, sales and service organizations in 19 countries and an international network of dealers. The global management is headquartered in Wetzlar, Germany.

If you had any doubts whether the various types of social media (e.g., Twitter, Facebook) were here to stay, take a look at a recent news article concerning a new hire the University of Michigan (see: University of Michigan social media director hired at $100K per year):

via labsoftnews.typepad.com

One of my all-time heroes as a child was Albert Einstein.  Regarded as one of the greatest minds of the 20th century if not civilization itself, he had an incredible personal story, professional triumphs and personal tragedies.  I used a quote of his to begin my essay for medical school: "“Imagination is more important than knowledge. For knowledge is limited to all we now know and understand, while imagination embraces the entire world, and all there ever will be to know and understand.”

There are dozens of other great quotes attributed to him, including "We can't solve problems by using the same kind of thinking we used when we created them" or "Logic will get you from A to B.  Imagination will take you everywhere".

Perhaps my favorite one is attributed to Einstein while helping a group of school-aged children with their math studies: "Do not worry about your difficulties with mathematicss; I can assure you mine are much worse".

Over 10 years ago a book was published entitled Driving Mr. Albert written in first person with someone who drove across America with Einstein's brain and the pathologist who for years had kept it in formalin. In addition for the trip, he talks about the problems associated with keeping wet tissue and the pathologists' problems, issues, paranoias and difficulties for doing so for decades.

Einstein died in 1955 at Princeton University due to a ruptured aortic aneurysm.  At the time he became ill he was offered surgery by a Dr. Nissen (I gather of Nissen fundoplication) to repair the aneurysm.  He refused.  The treatment offered to him at that time was a vascular graft, still experimental at the time, but an improvement over the standard therapy in early studies.  The other treatment was wrapping the aneurysm in saran wrap.  Grafts are standard of care today unless interventional radiology does it less invasively today by other means.

Anyways, looks like a trip to Britain is order as sections of the much talked about brain of Einstein will be on public display, news to me thanks to The Pathology Blawg.  Read more here.

Once again, Ole Eichorn, Aperio's Chief Technology Officer and The Daily Scan blogger put together a nice photo montage with captions and highlights from this years USCAP meeting exhibit floor.  In addition to showcasing Aperio's booth and products, Ole highlights many other companies, their products and how many other vendors are using digital pathology or services that tie into digital pathology.

Aperio also released their ePathViewer for iPad last week.  Was able to get a sneak peak at this from some Aperio folks earlier this month and is a must have for whole slide afficiendos. Reviewed some Juan Rosai collection slides as well as some SecondSlide cases with the app and despite a slow network the image refresh rate (and quality) were excellent (pre getting my iPad3 with HD display).

Below the screen shot below on the App Store you can also see other iPad viewers for viewing other whole slide images from Leica, Motic, Objective Pathology & large medical images with cool names like WholeSlide, iPathology and SlidePath.

Is was not so long ago that digital pathology relied upon being tethered to a desktop PC with enough RAM and bandwidth to view the images.  

No more.  Digital pathology is mobile!

The days of being tethered to your histology laboratory, your microscope and your laboratory information system (thanks to web-based LISs) are over.  

Next-generation Pathology

Pathology faces increasing competition from the modern methods of molecular biology. Genomics and proteomics promise to provide unbiased, quantitative data revealing insights into origin and progression of disease. Will pathology need to change in order to defend its territory? Quite certainly. Should pathologists forget what they have learned over the centuries? I don’t think so.

It could be claimed that the basic pathological methods have changed too little since the invention of the light microscope. However, the basic reason to look at histological samples didn’t change either. The morphological details of heterogeneous tissue provided invaluable information well before genes and proteins were discovered. And they continue doing so ever since.

Genes and proteins are essential components of the molecular magic that brings about tissue morphology (among other things). No biological science can afford ignoring all we have learned about them in the recent past. At the same time, genetic fingerprints and protein profiles are mostly obtained from blood or homogenized tissue samples that lack the spatial dimension histology is all about.

Tissue slides reveal the complex interplay between different cellular populations, their gene expression levels and metabolic status. They thus are a more comprehensive readout of molecular dynamics than any molecular technique alone could ever provide. Pathological scores, though, are necessarily less comprehensive. They aim at reducing complexity in order to increase consistency. They are so successful at achieving the former, that the quantitative requirements of modern science are hardly met. Yet they often fail to establish the latter as inter-observer variation remains high.

Next generation pathology will need to integrate molecular techniques into the traditional framework of histology: the morphological complexity of heterogeneous tissue. The required methods are well established and they are now transforming pathology. Immunohistochemistry combines molecular information on protein levels with spatial context. Novel methods based on in situ hybridization are reaching the maturity required to complement the histological toolbox. One by one, IHC stains put proteins into context. SISH, CISH, FISH et al. now do the same with genes. These advances open another dimension to the information that can be derived from histological samples. The spatial dimensions can be complemented with molecular ones. And the molecular information can be added to the information residing in tissue instead of competing with it.

As usual, the next generation comes along with novel toys. Automated image analysis is required to capture the quantitative readouts promised by the molecular advances. In order to go beyond genomics and proteomics, pathological knowledge will have to be accounted for and it is thus essential to make the novel approaches available to pathologists. To get from toys to tools, automated image analysis solutions need to be straightforward enough to be used routinely by pathologists. At the same time, they need to be flexible enough to robustly cope with the heterogeneity of histological samples.

Tissue proteomics and tissue genomics should be the pathologist’s reply to the molecular challenge they face.

For more information on this, check out Definiens Webinar series, including one this Thursday entitled "Quantitative Digital Pathology Out-of-the-Box: Definiens Tissue Studio Combines Flexibility and Ease-of-Use with High Productivity". Click here to register.

Thursday March 29th, 2012

CBLPath recently announced it is one of a select few labs within the United States to offer Vysis(R) ALK Break Apart fluorescence in situ hybridization (FISH) testing for non-small cell lung carcinoma (NSCLC). The Vysis ALK FISH test detects rearrangements in the ALK gene employing fluorescent probes to detect the presence or absence of specific DNA sequences.

Vysis ALK FISH is the only FDA-approved companion diagnostic for XALKORI(R) (crizotinib). XALKORI was recently approved under the FDA's priority review program for treatment of patients with late-stage NSCLC who have an abnormal ALK gene. XALKORI has been shown to inhibit the proliferation of ALK, thereby suppressing growth of NSCLC tumors.

"CBLPath is proud of the positive impact our work has on patients' lives," said Chief Medical Officer, Dr. Carlos D. Urmacher, FCAP, FASCP. "Keeping at the forefront of the latest technologies ensures our clients and their patients have access to the best therapies available. By receiving approval from New York State to run the Vysis ALK FISH test, we are able to help clinicians identify those patients who will benefit from treatment with XALKORI."

Non-small cell lung cancer is the most common type of lung cancer with approximately 170,000 new cases per year in the United States. Non-small cell lung cancer includes adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. There are a variety of treatment options for NSCLC, and a patient's success with any treatment option is dependent upon their genetic profile. About 1-7% of patients with NSCLC possess the ALK gene abnormality. These patients are typically young and non-smokers. Patients with the ALK mutation respond favorably to treatment with XALKORI.

XALKORI is a registered trademark of Pfizer Inc. Vysis is a registered trademark of Abbott Laboratories.

Full press release.

CMS is delaying implementation of Transmittal 2407 containing “revised and clarified” point-of-service (POS) coding instructions from April 1 to Oct. 1, 2012. The delay will be announced in Transmittal 2435, which the agency is planning on posting on its Web site. (The agency’s Web site is apparently experiencing technical difficulties, and the Transmittal is not yet posted. The CAP will post a link to the Transmittal on the Advocacy Web site when it is live.)

As outlined in the March 15 issue of Statline, the CAP extensively engaged with CMS officials, explaining to them that if implemented, the transmittal would result in significant confusion regarding anatomic pathology services, particularly for Medicare carriers processing claims subject to the technical component “grandfather” provision in light of its scheduled July 1^st expiration date.
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