The Washington Post (7/19, Overly) in its Capital Business column reported that the Food and Drug Administration has "proposed its first-ever regulations of the burgeoning mobile health industry" Tuesday, concentrating on a "segment of applications that officials described as being akin to medical devices." FDA policy adviser Bakul Patel, who helped develop the guidelines, "said the agency sought to balance the potential for innovation with patient safety in the rapidly changing mobile space." The guidelines suggest "three types of applications should require the FDA's sign off: a mobile application that acts as an accessory to a regulated medical device, turns a mobile gadget into such a device or makes suggestions regarding a patient's diagnosis or treatment."

Courtesy of the Digital Pathology Association.

I think this year's Pathology Visions program is going to be excellent with more news about the program to follow shortly.  If you have attended before, I think you will find the topics for this year's speakers very engaging, current and practical.  If you haven't been before, this may be one program to include among your meetings this Fall.

World-renown pathologist, Dr. Mahul B. Amin, will discuss this and more at the 2011 Pathology Visions Conference. Dr. Amin's keynote address will also focus on the role of the pathologist in contemporary health care and discuss the contributions, strengths and limitations of traditional microscopy.

(PRWEB) July 19, 2011 

How does personalized medicine fit into the ever-evolving world of digital pathology? Mahul B. Amin, M.D. will share his perspective on the topic and more at the 2011 Digital Pathology Association’s Pathology Visions Conference. The 7th annual international conference will be held Oct. 30 – Nov. 2, 2011 in San Diego, CA at the Manchester Grand Hyatt.

Dr. Amin’s keynote address promises to shed light on how personalized medicine relates to the discipline of pathology. Dr. Amin currently serves as the Chairman and Professor of the Department of Pathology and Laboratory Medicine at Cedars-Sinai Medical Center. His talk will also review the role of the pathologist in contemporary health care and discuss the contributions, strengths and limitations of traditional microscopy. Topics many in the field of digital pathology will find intriguing.

“We are honored to have Dr. Amin, a recognized pathology leader, as the keynote speaker at this year’s Pathology Visions Conference,” said Dirk Soenksen, President of the Digital Pathology Association and Chair of the Pathology Visions Program Committee. “The focus of Dr. Amin’s keynote address is particularly relevant, since digital pathology is a catalyst in providing pathologists with the tools and information required to be successful in the era of personalized medicine.”

The Pathology Visions Conference will also showcase more than 35 additional distinguished speakers who will share their breadth of digital pathology knowledge in the clinical, research and education arenas.

Additionally, the Pathology Visions Conference will feature dozens of cutting-edge industry workshops, an extensive exhibit hall filled with the latest product solutions, access to white paper sessions, round-table discussions, scientific poster sessions, and networking events.

The Digital Pathology Association’s annual meeting is the premiere conference dedicated solely to the field of digital pathology. Conference attendees travel from around the world to take part in this yearly must-attend event for anyone working with, or interested in, digital pathology. The Pathology Visions Conference supports the mission of the Digital Pathology Association to facilitate education and awareness of digital pathology applications in health care.

To learn more and to register for the 2011 Pathology Vision’s Conference visit http://digitalpathologyassociation.org/pathology-visions-conference.

(Submitted by Steve Potts, CEO of Flagship Biosciences, a digital pathology services company). 

On July 12, 2011, the FDA released a new draft guidance on the development and review of companion diagnostics (CDx). I would encourage anyone working in anatomic pathology to review the draft, as it will have widespread impact on digital pathology companies, antibody providers, and anatomic pathologists in both private practices and large reference laboratories. The guidance was also discussed in Dr. Elizabeth Mansfield's presentation available at the Molecular Diagnostics for Cancer Drug Development June meeting in Boston. 

The most important point can be summarized by one equation:

Failure/lack of test approval = no therapeutic product approval

If this doesn't make get your attention, nothing will. An approved drug can cost from $200M to $1.2B to develop (wide variability in costs is largely due to indication type, you can make your own calculations). Let's recast the equation in terms of the cost of failure for the companion diagnostic and the cost of failure for the therapeutic. A good example is HER2 IHC, which brings in $50M in total global annual sales divided across a handful of chemistry and image analysis players. Let's assume the next big companion diagnostic is almost this big -- and the firm has only four other competitors. So $10M in lost sales per year, perhaps spread over 10 years, and perhaps $10M spent on development. Total cost of failure for the CDx -- $100M. 

Now let's look at the failure cost of the therapeutic due to CDx failure, continuing with the HER2 example. Herceptin had total ten-year sales from 1998 to 2008 of $7.7B, and has climbed higher the last two years. Let's assume only 10 year sales, meaning total cost of failure is lost development costs of $1B and lost ten-year sales of $7.7B.  

$100M =? 7.7B                    Lost Sales Cost
$10M =? $1B                       Lost Development Costs 

One can see the imbalance clearly between the diagnostics and therapeutics industry. Having worked in both diagnostics and therapeutics, the only thing the two industries have in common is biology.

Clearly every pharmaceutical executive will re-examine carefully all the risks involved in their companion diagnostics programs, as CDx competency becomes a determining factor in success or failure for pharma. Does their translational companion diagnostic team have experience launching diagnostic products? Do they have experience in regulatory filings of 510k and PMAs? Is there any part of the diagnostic technology that is not already well proven and widely used in clinical laboratory settings? Has their CDx internal pharma team or external CDx team actually worked in clinical laboratory settings?  

In the next several posts, we will look at the specifics in the CDx policy, and then what impacts we might predict for IHC and FISH/CISH based anatomic pathology testing. 

—

Among other topics, this FREE White Paper specifically addresses:

1. Current State of Uninsured Patients in US
2. The Pros and Cons for Health Insurers
3. Transparency in Laboratory Test Pricing
4. Why Lab Test Firms Can Improve Patient Care

For more about internet-based laboratory test access for un-insured, please CLICK HERE

Table of Contents

Introduction — Page 3

Chapter 1. Current State of Uninsured/Under-Insured Patients in the US. — Page 5

Chapter 2. Transparency in Medical/Medicare Laboratory Test Pricing — Page 7

Chapter 3. Pros and Cons for Health Insurers — Page 11

Chapter 4. Case Study: Creating Transparency in Today’s Laboratory Test Pricing — Page 14

Chapter 5. Why Internet Lab Test Firms are Important for Improving Patient Care — Page 17

Chapter 6. Conclusion — Page 19

Appendices

A-1 About Joseph Burns — Page 22
A-2 About PrePaidLab.com — Page 23
A-3 About DARK DAILY— Page 24
A-4 About The Dark Intelligence Group, Inc., and The Dark Report— Page 25
A-5 About Executive War College on Laboratory and Pathology Management— Page 26
A-6 About Robert Michel — Page 28  

Terms of Use — Page 32

Courtesy of the San Francisco Chronicle via PRWeb

The Association for Pathology Informatics is awarding a limited number of stipends of $1,500 to attend the Pathology Informatics 2011 Conference at the Pittsburgh Wyndham Grand hotel in Pittsburgh. The conference will take place on October 4-7, 2011. Awardees must be residents, post-doctoral students, or fellows in accredited teaching programs. This is the premier pathology informatics conference in the country with three workshops, three discipline tracks, multiple keynote plenary lectures, 44 participating faculty members, and more than 40 exhibitors. Last year's PI-2010 presentation marked the first of these events. The conference represents a merger of two long-standing pathology informatics meetings, APIII and Lab InfoTech Summit. The application deadline for awards is August 1, 201, so those interested should apply soon. Applicants must be residents or fellows in a training program accredited by the Council for Graduate Medical Education (ACGME). More details can be obtained at the conference web site including details about how to apply.

via labsoftnews.typepad.com

The CMS has proposed an array of rule changes affecting physicians and their use of health information technology under various Medicare and Medicaid payment regimes, including delaying for at least a year a requirement for the direct, electronic reporting of physician quality data as part of the meaningful use requirements of the electronic health-record incentive payment program under the American Recovery and Reinvestment Act of 2009.

By Joseph Conn from Modern Physician

Posted: July 12, 2011 - 11:45 am ET

Henderson, Nevada, USA, and Belfast, Northern Ireland, UK July 13, 2011

DigiPath, Inc®, a provider of affordable, innovative, and reliable digital pathology solutions, and PathXL Ltd., a company that specializes in developing web-based software for digital pathology, have joined together to increase user adoption of digital pathology within North America based academic medical centers through educational applications.  DigiPath and PathXL will be showcasing PathXL™ Tutor and PathXL™ Simulate digital pathology education applications as the only PREMIER Platinum Industry Sponsors at the Association of Pathology Chairs Annual Meeting in Monterey, CA, USA from July 13 through July 15, 2011.

PathXL™ Tutor allows users to effectively create and manage digital slides and other content, publish online, share and view from anywhere in the world. PathXL™ Tutor provides on-line virtual microscopy teaching, educational, CPD and competency exam resources in minutes, significantly enhancing student, trainee and the professional experience.

PathXL™ Simulate supports early stage training for residents in pathology. Trainees can work through real cases and assess how well they have performed. This approach to training has been completely embraced by numerous laboratories worldwide.

“For over seven years, PathXL has been the European leader in implementing digital pathology medical education software applications,” stated Des Speed, Chief Executive Officer of PathXL. “60% of United Kingdom trained pathologists utilize PathXL™ Tutor each year.”

“PathXL’s innovative product line is the foundation of DigiPath’s digital pathology solution portfolio” said Eric Stoppenhagen, Chief Executive Offer of DigiPath. “DigiPath and PathXL are well positioned to be the market leader within digital pathology medical education.”

About DigiPath, Inc.

DigiPath, Inc. provides the next generation of affordable, innovative, and reliable digital pathology solutions. DigiPath’s advisors bring over 60 years combined expertise in pioneering digital pathology, implementing over 500 installations at community pathology practices, hospitals, academic medical centers, reference laboratories, biopharma organizations, and life science research institutions worldwide.

About PathXL Ltd.

PathXL Ltd is a company that specializes in developing web-based software for Digital Pathology. Their proprietary webbed image management database and digital slide viewing platform – PathXL™ – together with purpose built application software, underpins a wide range of applications including (i) education and training in pathology, (ii) Digital slide archiving, (iii) cloud based digital pathology (iv) biobanking (v).

Print media provided extensive coverage of the Obama Administration's announcement on Monday of new rules for the state health exchanges mandated by the healthcare law. Most sources agree that in crafting the regulations, the Administration sought to provide states with much flexibility. Coverage was generally positive, although some sources said that the rules may lead to more questions.

The New York Times (7/12, A12, Pear, Subscription Publication) reports, "In a big step to carry out the new health care law, the Obama administration unveiled standards on Monday for insurance marketplaces that will allow individuals, families and small businesses in every state to shop for insurance, compare prices and benefits and buy coverage." HHS Secretary Kathleen Sebelius "said the insurance exchanges, the centerpiece of the new law, 'will offer Americans competition, choice and clout.'"

The Los Angeles Times (7/12, Levey) reports, "These state-based exchanges are intended to make buying a health plan comparable to shopping the Internet for an airline ticket or a hotel room. And by 2019, they are expected to serve as the main insurance resource for an estimated 24 million Americans who don't get their health insurance from their employer, according to the nonpartisan Congressional Budget Office." Small businesses "with fewer than 100 employees also will be able to use the exchanges, which will have to offer plans with a minimum level of coverage." In addition, "no plans will be able to deny coverage to people with pre-existing conditions." 

The Wall Street Journal (7/12, Mathews, Subscription Publication) reports that health exchanges are crucial to the healthcare law, and the new regulations aim to provide states with flexibility in implementing them. Yet, to date, only 12 states have passed legislation to create them. The Journal says that because states have so much leeway in these new regulations, they could face struggles about how much authority exchange regulators should have.

The Hill (7/12, Baker) reports in its "Healthwatch" blog, "The proposed rule leaves most key decisions up to the states, though it sets some minimum standards for every exchange -- including limits on the role of insurance companies and agents."

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The challenges facing the clinical laboratory environment in the past 10 years are well documented, and include significant medical technologist vacancy rates, increased competition, and a significant number of opportunities to inadvertently make testing errors.1,2 With such macroeconomic challenges, the industry has used a variety of methods to identify ways to increase productivity, decrease costs, and in general, become more efficient at generating test results.

A cornerstone of “Lean Thinking” involves the elimination of waste, including the identification and removal of inefficient processes or tasks. In the laboratory, if manual processing steps can be eliminated without sacrificing quality, then there will be less manual manipulation of tubes, fewer opportunities for errors, and a better overall turnaround time for reporting results.

In addition to the removal of waste, Lean also provides a benefit in terms of workload leveling. As anyone who has worked in a laboratory knows, problems meeting turnaround time goals and maintaining efficient specimen processing occur whenever a surge of work arrives into the laboratory. Workload leveling is simply the practice of handling work in small, consistent batches which will encourage standardization and therefore reduce variation and errors. The most successful Lean projects address the issue of workload leveling and standardization along with waste removal.

In vitro diagnostic (IVD) equipment manufacturers are complementing these Lean efforts by providing analyzers and testing solutions to help eliminate wasteful process steps, standardize the laboratory workload, and focus on improved turnaround times.5 Instruments with improved ergonomics, reagents with visual and color coded designators, and technology that encourages “continuous operational flow” are all features that have become mainstream in IVD product development circles.

Here is just some of what you will take away…

• How to adopt Lean quality management methods designed to increase productivity and efficiency.
• How to identify inefficient processes or tasks.
• How to create a Lean environment for ISD monitoring in the routine laboratory setting.
• and much much more!

Table of Contents

• Disclosure
• Introduction
• Chapter 1. Study Area
• Chapter 2. Background
• Chapter 3. Study Methodology
• Chapter 4. Results
• Conclusion
• References
• Appendices
  A-1 About Tim Baker
  A-2 About Nexus Global Solutions
  A-3 About Karen Appold
  A-4 About DARK Daily
  A-5 About The Dark Intelligence Group, Inc., a nd THE DARK REPORT
  A-6 About the Executive War College on Laboratory a nd Pathology Management
• Terms of Use 

These are exciting times for i-Path, the Northern Ireland based firm, as it prepares to announce its US launch with the new company name, PathXL. i-Path will undergo a corporate rebrand to PathXL for all customers from the end of August 2011. In the meantime PathXL™ Tutor and PathXL™ Simulate, their education and training digital pathology products, will be introduced in the US by DigiPath, Inc®, beginning at the Association of Pathology Chairs Annual Meeting (link) in Monterey, California, USA from July 13^th-15^th 2011.

DigiPath and PathXL invite you to their stand to hear the exciting news regarding PathXL™ Tutor and PathXL™ Simulate in the USA.

PathXL Tutor

The dedicated software platform, PathXL™ Tutor, allows users to effectively create and manage digital slides and other content, publish online, share and view from anywhere in the world.

What you can do with PathXL™ Tutor?

• Generate on-line virtual microscopy training, CPD and competency exam resources in minutes, significantly enhancing student, trainee and the professional experience.
• Incorporate various multimedia files including streaming videos, presentations, sound files, PDFs and Office documents.
• Build online proficiency tests, incorporating virtual slides and having results from participants stored centrally. Scores can be compared against peer groups at the end of each test.
• The powerful web based virtual slide viewer is rich with features including annotations, slide measurements, screenshots and multi-slide review.
• Build PathXL™ Tutor into your current website, creating an education portal for members only or make publicly available.
• PathXL™ Tutor is entirely web based and accessible via any web browser.
• PathXL™ Tutor runs through a standard internet port. No downloads or plugins required.
• PathXL is vendor neutral and supports virtual slides and file formats from all major scanning manufacturers.

PathXL™ Simulate

PathXL™ Simulate is aimed at supporting early stage training for residents in pathology. Trainees ‘learn by simulation’ by working through real cases and assessing their performance.

This approach has been embraced by numerous laboratories across the world including the Thames and Medway Training Schools, Liverpool Training School, South West Deanery Training School and the Royal College of Pathologists of Australia (RCPA).

Key Benefits:

• Approved training materials in diagnostic pathology
• High resolution digital images of the entire slide
• Learn to identify the key morphological clue in diagnosis
• Track diagnostic performance from morphology interpretation to diagnosis
• Train in a consequence free environment
• Generate performance report on cases
• Improve diagnostic ability and performance
• Develop the skill sets of the world’s leading pathologists
• Learn to identify the key morphological clues in diagnosis
• Used to complement one-to-one training
• Web-based software can be accessed anytime, anywhere
• Objective algorithms aimed at improving reproducibility and precision across the profession.

About PathXL

PathXL Ltd is a company that specializes in developing web-based software for Digital Pathology. Their proprietary web-based image management database and digital slide viewing platform – PathXL™ – together with purpose built application software, underpins a wide range of applications including (i) education and training in pathology, (ii) digital slide archiving, (iii) cloud based digital pathology, (iv) biobanking, (v) biomarker discovery and multiplex data management and analysis and (vi) web-based image analysis for tissue analysis. US customers can visit http://www.pathxl.com and http://www.digipath.biz to view PathXL’s products and services.

Rest of world customers (including UK) please continue to use the company website http://www.i-path.co.uk until we also complete our renaming to PathXL, which we will advise you about in August.

About DigiPath, Inc.

DigiPath, Inc. provides the next generation of affordable, innovative, and reliable digital pathology solutions.  DigiPath’s advisors bring over 60 years combined expertise in pioneering digital pathology, implementing over 500 installations at community pathology practices, hospitals, academic medical centers, reference laboratories, biopharma organizations, and life science research institutions worldwide.

Visit http://www.digipath.biz monthly to see new solutions emerge during 2011.

Last month the folks at Mikroscan paid our group a visit to show us their latest scanner.  This new recently released scanner launched shortly after their first generation model has several improvements on an already solid platform.  For starters, it is 40% smaller than their "larger" desktop model facilitating placement even in the tightest offices and laboratory workspaces.  Secondly, the device produces no noise during scanning. 

A 15 x 15 mm piece of tissue was scanned in 20x in well under 2 minutes.

One of the most impressive features about the device is the ability to look at the same slide and the same time with very short scan times (less than 30 seconds) for the remote viewer. 

One of the many value propositions for digital pathology remains telepathology.  The simple, time tested and often used clinical business practice of looking at the same slide at the same time with either a sub-specialist and/or trusted colleague that is done routinely in the analog world can be done at greater distances with telepathology. 

Digital pathology and devices such as Mikroscan's scanner provides for the device to be placed within the pathologist's workspace, thus facilitating workflow and optimizing the experience for both the sending and receiving pathologist.

Imagine having a case that needs someone else's eyes and on your desk is a scanner that can create a digital slide and present those images very quickly to another person. The images, as frequent readers from an earlier post (see: Mikroscan images to be seen) may recall I thought highly of the images (as well as the viewer interface) while other options exist for the viewing as well.

This is not to say that you can eliminate or should not consider the other 4 slide, 5 slide or several hundred slide scanners on the market today.  You should.  But I also think that pathologist's should consider a lower capacity, desktop device as well, particularly for remote frozen sections, isolated pathologists that rely on courier models for second opinions or where the opportunity exists for subspecialty consultation within a group or as an extramural consultation. 

More extensive adoption of digital pathology will rely on a basic premise that may be met with a Mikroscan device: Cost-effective solutions that produce high quality images readily and consistently.

I think that the use cases in pathology are unique enough and individual enough to recognize a need and a market for both lower as well as higher capacity scanners to meet our day-to-day needs. 

Check out Mikroscan for more details.

"Students have been delighted with its (PathXL’s) ease of use and its 24 hour, 365 day accessibility." Dr. Stephen McCullough, Head of Anatomy, Queens University Belfast

i-Path’s PathXL software continues to provide an innovative approach to classroom learning. A number of leading educational centres in the UK and further afield are recognising the benefits that PathXL can bring to medical education.

Queen's University, Belfast (link) is an institution with a world-class academic reputation and is a member of the Russell Group of leading UK universities. Conventional microscopy was proving to be ineffective in teaching the approximately 2300 students in the School of Medicine, Dentistry and Biomedical Sciences; it was time consuming, difficult to establish standards in teaching or examining and unpopular among students.

With the help of i-Path, Queen’s introduced a virtual microscopy solution. By using PathXL, virtual slides could be viewed on-line and used in the same way as a conventional microscope by large numbers of students or trainees over a computer network, thus avoiding the necessity for them to be at a particular venue at a set time to attend a teaching or training session.

PathXL has helped enhance the learning experience of students who can practice histology in a digital environment in both the classroom and at home. ?PathXL facilitates group learning as it enables students to discuss interesting slides on large computer monitors by viewing them digitally. In addition, with classroom control software, tutors can control single or multiple classroom monitors and communicate with individual students, with groups or the entire classroom from the front of the class.

"This versatile system has allowed us to construct practical classes that can interactively link a range of study material including virtual slides, micrographs, x-rays, anatomical specimens and lecture material." Dr. Stephen McCullough, Head of Anatomy, QUB

---------------------------------------------------------------------------------------------------------------

The University of Glasgow, School of Veterinary Medicine (link) has also chosen PathXL to help transform its learning environment.

In 2010 a new course in veterinary pathology was introduced for the undergraduate veterinary students, focussing on developing their enthusiasm for pathology in both practical, clinical and research contexts.

PathXL now provides the students with access to histopathological slides, including cytological smears. This system has been used to enhance laboratory-based microscopy classes at the University of Glasgow by enabling students to view, at their convenience, labelled slides in their area of study.

"Research has shown that veterinary students are comfortable with this type of computer-based study of pathology, committing larger periods of time to study of the course material than they are able to in microscope-based classes alone"  Dr. Pamela Johnston, University of Glasgow, Faculty of Veterinary Medicine

PathXL has also been used in institutions such as Michigan State University (Veterinary Online Atlas), Nottingham University Hospital (Education Portal) and the Pathological Society (Educational Portal).

PathXL – Key Benefits For StudentsEnhanced learning experience

• Ease of use
• Freedom from optical stress
• Better image quality
• Time saving

Path XL – Key Benefits For Administrators

• Ability to construct course-specific modules
• Versatility
• Practical classes can include a range of resources
• Slides available to everyone at the same time
• Cost savings

i-Path has a unique team of scientists and software developers that can offer advice and consultancy on a wide range of issues relating to virtual microscopy.

For further information please visit http://www.i-path.co.uk or contact us at contact@i-path.co.uk.

A new digital pathology vendor hits the market today.  Affordable and innovative solutions to meet both clinical and research/biopharma needs will be required for DigiPath in an increasingly competitive landscape, particularly for hospitals - both community-based groups and academic medical centers to be successful.  Check out their new website at http://www.digipath.biz for more information.

DigiPath, Inc.™ today announced its entry into the digital pathology market. DigiPath provides the next generation of affordable, innovative, and reliable digital pathology solutions. DigiPath’s solutions will support community pathology practices, hospitals, academic medical centers, reference laboratories, biopharma organizations, and life science research institutions.

“The medical community is looking for more affordable, innovative, and reliable digital pathology solutions to assist in enhancing patient care,” commented Keith Kaplan, M.D., Editor, Digital Pathology Blog™ at http://www.tissuepathology.com. “DigiPath seems well positioned to help our community practices expand digital pathology adoption.”

“In June 2010, we surveyed over 400 CLIA™ certified labs concerning digital pathology adoption”, stated Jondavid Klipp, Publisher, Laboratory Economics™. “55% of the respondents said that digital pathology was too expensive. Affordability is an important concern to pathology laboratories.” 

“The DigiPath team brings a combined 60 year experience within the digital pathology field”, said Eric Stoppenhagen, Chief Executive Officer. “Our team pioneered digital pathology by implementing over 500 installations worldwide. During the coming years, DigiPath will be providing affordable, innovative, and reliable digital pathology solutions.”

About DigiPath, Inc.

DigiPath, Inc. provides the next generation of affordable, innovative, and reliable digital pathology solutions. DigiPath’s advisors bring over 60 years combined expertise in pioneering digital pathology, implementing over 500 installations at community pathology practices, hospitals, academic medical centers, reference laboratories, biopharma organizations, and life science research institutions worldwide.

Visit http://www.digipath.biz monthly to see new solutions emerge during 2011.

SAFE HARBOR STATEMENT

This Press Release may contain certain forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. DigiPath has tried, whenever possible, to identify these forward-looking statements using words such as "anticipates," "believes," "estimates," "expects," "plans," "intends," "potential" and similar expressions. These statements reflect DigiPath's current beliefs and are based upon information currently available to it. Accordingly, such forward-looking statements involve known and unknown risks, uncertainties and other factors which could cause DigiPath's actual results, performance or achievements to differ materially from those expressed in or implied by such statements. DigiPath undertakes no obligation to update or provide advice in the event of any change, addition or alteration to the information catered in this Press Release including such forward-looking statements.

Leica continues to innovate in short order considering how long they have been in the digital pathology market I think this is very quick to launch a florescent scanner.

Leica is now offering a combined brightfield and fluorescent scanner and image management application that may be attractive to the research world as well as large clinical laboratories.  See link below to preview some of their images.  

Welcome your feedback on the blog about image quality, much like Facebook on Leica's iPad application.

Multi-channel fluorescent scanning for Digital Pathology

Wetzlar, Germany. Leica Microsystems announces the release of the Leica SCN400 F combined fluo­rescent and brightfield digital slide scanner. The SCN400 F brings together Leica’s award winning brightfield slide scanning capabilities and multi-channel fluorescence imaging in a single platform, providing versatility to researchers and core laboratories utilizing Digital Pathology.

By employing two separate illumination and scanning methods, the Leica SCN400 F ensures excellent brightfield scans and crisp multi-channel fluorescent images from one device. Scanned slides are readily re­viewed online through the SlidePath Digital Image Hub web-viewer, incorporating the ability to turn on and off separate channels with the click of a button to examine each marker individually.

To view a sample fluorescent image, please visit our Virtual Slide Gallery at http://www.leica-microsystems.com/products/digital-pathology.

Dr. Donal O’Shea, Head of Digital Pathology in Leica Microsystems says, “The Leica SCN400 F is a significant breakthrough for researchers looking for an affordable solution for scanning brightfield and fluorescent slides. With the ever growing adoption of immunofluorescent staining in research to study multi-marker co-expression in oncology and neuroscience, we see the SCN400 F as a valuable tool for core laboratories, bringing increased efficiency and quality to research practices.”

The Leica SCN400 F is the newest scanning solution in the Total Digital Pathology portfolio, demon­strating Leica’s drive and innovation in this market. Leica Microsystems’ broad range of interoperable Digital Pathology components provides customers with the flexibility to choose the solution that is right for their needs.

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Leica Microsystems is a world leader in microscopes and scientific instruments. Founded as a family business in the nineteenth century, the company’s history was marked by unparalleled innovation on its way to becoming a global enterprise.

Its historically close cooperation with the scientific community is the key to Leica Microsystems’ tradition of innovation, which draws on users’ ideas and creates solutions tailored to their requirements. At the global level, Leica Microsystems is organized in four divisions, all of which are among the leaders in their respective fields: the Life Science Division, Industry Division, Biosystems Division and Medical Division.

Leica Microsystems’ Biosystems Division, also known as Leica Biosystems, offers histopathology labo­ratories the most extensive product range with appropriate products for each work step in histology and for a high level of productivity in the working processes of the entire laboratory.

The company is represented in over 100 countries with 12 manufacturing facilities in 7 countries, sales and service organizations in 19 countries and an international network of dealers. The company is head­quartered in Wetzlar, Germany.

A loyal reader put me onto DRdoubleB over at YouTube, a pathology resident at the University of Florida who put together some high quality music videos with a pathology theme.  

Check out "Dynamite Case" about the trials and tribulations of daily sign-out, grossing and trying to go to meetings, "I Got It" for nailing a sarcoma diagnosis & "I Like Path That Way" which has more attending input on the video. Pretty sure my attendings in residency would either not have supported these videos or appeared in them. 

Looks like a fun department with a talented resident and supporting cast.

Partnership forged to tackle tumor heterogeneity

Cambridge, MA and Munich, Germany – June 30, 2011 – Metamark Genetics, a privately held oncology molecular diagnostic company, and Definiens, the leading Health Image Intelligence™ company, today announced a development and commercialization partnership in which Metamark will combine its proprietary multiplex protein detection platform with image analysis technology developed jointly with Definiens to deliver innovative prognostic and predictive assays for early-stage cancers.

"Definiens is a clear world leader in quantitative digital pathology and in the analysis of biomarkers in tissue image data,” said Eric Devroe, Ph.D, Vice President of Business & Strategy Development for Metamark. “We see great synergy in combining Definiens’ technology and expertise with Metamark’s unique understanding of tumor heterogeneity and insight into the molecular drivers regulating tumor formation and aggression. We believe that this partnership will enable us to co-develop and implement unique and important image analysis tools."

Metamark’s quantitative diagnostic approach can identify and account for small regions of molecularly aggressive cancer cells within an otherwise indolent tumor. The company is developing a portfolio of prognostic and predictive assays with the ability to address the "heterogeneous" nature of tumors not only between one patient and the next, but also within an individual patient’s tumor.

Definiens has made ground-breaking achievements in the field of biomarker development based on its highly robust and scalable image analysis framework that enables scientists and clinicians to rapidly extract comprehensive biomarker and morphology expression profiles and to identify a relevant subset of descriptors by correlating them against patient outcomes.

"Definiens is pleased to partner with Metamark Genetics, and to incorporate our image and data analysis software technology into Metamark’s pioneering Oncology diagnostic offerings," said Thomas Colarusso, Vice President of Sales & Operations for Definiens Inc. "The capability to provide detailed readouts from tissue analysis is opening up new gateways for developing diagnostic assays as we enter the age of personalized medicine. We believe the Definiens Developer XD and Tissue Studio software will enable Metamark to classify tumor heterogeneity of multiplexed tissue stains and derive prognostic and predictive assays."

About Metamark Genetics, Inc.
Metamark is a privately held oncology company focused on the development of function-based prognostic assays for early staged cancers. The MetamarkDx™ Prognostic Assays under development are based on Metamark’s proprietary Prognosis Determinants™, genes discovered through leading edge cancer research and demonstrated to play a causal role in promoting tumor progression and spread. For further information, please visit the company’s website at  http://www.metamarkgenetics.com.

About Definiens
Definiens is a leading Health Image Intelligence™ company that develops software solutions for biomedical image analysis, data mining and clinical decision support. The company’s software analyzes images from cell-based assays, whole tissue slides and full body scans and allows users to correlate this information with data derived from other sources, supporting better decisions in research, diagnostics and therapy. By automating analysis workflows and generating new knowledge, Definiens provides pharmaceutical and biotechnology companies, research institutions, clinical service organizations and medical professionals with deeper insights, faster results and better decision support. Harnessing the power of image intelligence, Definiens supports personalized medicine and aims to significantly improve the quality of patients’ lives. Definiens is headquartered in Munich, Germany, and has offices throughout the United States. Further information is available at http://www.definiens.com.

Pre-emptive steps to avoid fines, overpayments and even jail time

LIVE EVENT JULY 20

YOUR PRESENTERS:

Jane Pine Wood, Attorney, McDonald Hopkins, LLC

Tom Rehwald, CPA, Chief Financial Officer, InCyte Pathology, PS

Justin M. Clark (Moderator), Director of Operations, THE DARK REPORT

LIVE Event July 20 – Register NOW!

Recovery Audit Contractors Program (RAC) is the new Medicare program that sends independent auditors to provider facilities, including clinical labs and pathology groups. These auditors are out to recover an estimated $24 billion a year resulting from abuse, fraud, and reimbursement problems that have plagued the system for years.

How ready is your lab is for a RAC audit? Probably not very, which leaves you vulnerable when the first letter arrives from an auditor. That’s because the Centers for Medicare and Medicaid Services (CMS) have designated four independent companies to conduct RAC audits, and they’ll have surprising powers to view your source documentation.

So what steps can you take now to prepare your lab for a RAC audit? What are your rights during an audit? And how can you effectively challenge and appeal the results of a RAC audit?

Get answers to these questions and more when you register to attend the latest Dark Report and DarkDaily.com audio conference on Wednesday, July 20, 2011. Listen as two experts help you prepare your lab for an RAC audit-and how to minimize its impact.

CMS admits that most overpayments are caused by errors and omissions rather than fraud or abuse-many the result of incorrect coding or insufficient documentation. Still, it’s important to take steps now to fully understand the impact of a RAC audit, and what you can do to ensure that proper procedures are in place to reduce risk and limit your lab’s exposure.

In 90 minutes, you’ll get advice on surviving a RAC audit from the following two experts:

First, Jane Pine Wood, a health-law attorney who specializes in regulatory and compliance issues, provides critical details about the RAC audit program: what it is, how audits are performed, what areas are at risk of being audited, and more. She’ll walk you through the process, starting the moment your lab is notified it’s about to be audited. Using case-study examples, Ms. Wood will explain the procedures your lab should follow when responding to a RAC audit.

Our second speaker, Tom Rehwald, CFO at InCyte Pathology LLC, will share what happened when a RAC audit was conducted at his lab. He’ll provide the practical insights and lessons-learned that come from taking part in an actual audit. Find out how you can stay one step ahead of the auditors. Get a better understanding of the process, including the potential pitfalls you’ll need to watch out for when responding to the results of your audit.

In sports, they say the best defense is a good offense and that definitely applies when it comes to RAC audits. Taking steps now to identify and resolve potential problems before you’re audited can substantially reduce your risk of the auditors finding anything wrong.

Register today and get the best, most up-to-date information on how to prepare your lab for a RAC audit. Find out how to make risk assessment of your lab’s coding, billing and collections processes an ongoing part of your compliance activities. And how improving them can help you avoid future problems.

Finally, the results of an audit aren’t set in stone so don’t be afraid to challenge them, say our experts. One Florida lab appealed overpayments found during their RAC audit and was able to overturn almost 25% of them. In this session, you’ll find out how to decide whether an appeal makes sense, and if so, what steps your lab can take to contest the results of an audit.

This is a terrific opportunity for you and your management team to come up to speed on preparing for a RAC audit. Find out how to resolve noncompliance and overpayment issues before you’re hit with an audit.

And don’t forget: You can have everyone on your lab team participate with you. For just one registration, you can all listen, learn, and get personalized answers to questions about your lab’s unique needs. Register now to guarantee your participation.

For one low price—just $195 (through 7/8/11; $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 audio conference:

o The difference between a redetermination letter and reconsideration request, and what could happen if you mix up the two.

o The do’s and don’ts of crafting a redetermination letter to correct possible errors in your audit.

o Key steps for meeting compliance recommendations.

o The documentation that best supports the claims you submit to Medicare.

o How to prepare for an audit if you use a third-party billing service.

o How your lab can use the RAC experience to better educate staff and avoid future compliance and overpayment issues.

o The parallel strategies for attacking a RAC audit, including political action, that your lab should consider implementing

…and much more!

How to Register Now:

1. Online
2. Call toll free: 800-560-6363.

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 Faculty: 

Jane Pine Wood is a member of McDonald Hopkins, LLC which specializes in health law, including regulatory, compliance, and contractual matters, as well as Medicaid and Medicare reimbursement issues. Ms. Wood represents physicians, hospitals, clinical and anatomic laboratories, imaging centers, home health agencies, mental health providers, clinics, independent practice associations and integrated delivery systems in corporate, regulatory, reimbursement, contractual and other areas. She received her J.D. degree in 1987 from Vanderbilt University School of Law and is admitted to practice in Massachusetts, Ohio and Tennessee.

Tom Rehwald, CPA, has been Chief Financial Officer for InCyte Pathology, PS since 2007. He has been involved in healthcare finance and administration for more than 26 years, with experience that runs the full spectrum of a healthcare systems continuum of care. Prior to his current position, he was the CFO at Spokane Ear, Nose, & Throat Clinic and was CFO at Pathology Associates Medical Laboratories. He also held several positions at Providence Health Care/Sacred Heart Medical Center, including Director of Patient Accounts. He graduated Summa Cum Laude from San Diego State University with a Bachelor of Science degree in business administration with an emphasis in accounting.

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.