LLTech is creating innovative techniques for cellular imaging of fresh tissue. Recommend looking at this if you are involved with frozen sections, tissue banking, tissue mining, research and biobanking.
A reminder about our Light-CT webinar presentation - October 21st!
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Nice combination of leading companies combining whole slide and stereology. These are the type of applications that are not possible with analog slides alone and provide high throughput increased quantitation beyond light microscopy. The potential to analyze cellular biology through digital techniques over tumor biology alone with conventional microscopy will be one of the most significant value adds for digital pathology.
Partnership Expands High-Performance Digital Pathology Platform
Vista, CA and Hørsholm, Denmark -- October 20, 2011 -- Aperio, the global leader in digital pathology solutions that improve patient care, and Visiopharm, a leading provider of advanced software for quantitative microscopy for life sciences, today announced a partnership in which Aperio will market Visiopharm’s computer assisted stereological toolbox (newCAST™) in Europe.
Leveraging Aperio’s open architecture, newCAST Whole Slide Stereology package will be integrated into the company’s applications framework and accessible through its Spectrum™ information management system. The partnership expands Aperio’s existing suite of analysis tools that include area quantification, cell quantification, microvessel analysis, rare event detection and Genie histology pattern recognition.
“Our partnership with Visiopharm enhances our ability to provide stereological data to researchers," said Dirk G. Soenksen, CEO of Aperio. “We are excited that Visiopharm recognizes the value of marketing their leading Whole Slide Stereology tools on Aperio’s platform.”
Stereology allows researchers to answer fundamentally different research questions than image analysis or manual assessment of histological sections. With stereology, researchers can answer questions relating to total micro-structural content in 3-D, such as total number (of cells), length of structures, surface area of structures, and volume of structures. These properties are provided as statistically unbiased estimates with a known precision, and are based upon 2-D histological sections.
In particular, Aperio users who publish neurological, pulmonary and toxicologic data will benefit from the additional capabilities provided by this comprehensive set of stereology tools.
Dr. Michael Grunkin, CEO of Visiopharm, stated, “An increasing number of scientific societies and journals are realizing that accuracy of quantitative data requires stereological methods for estimation. Therefore guidelines recommending, and in some cases mandating, stereology for quantitative studies are being adopted. With increasing regulatory attention to stereology, biopharma executives and researchers are also realizing that stereology is a method they can no longer afford to ignore. With its patented Whole Slide Stereology software, Visiopharm is providing an efficient research tool that makes it realistic to include stereology even in research environments with high throughput requirements”
Aperio’s digital pathology platform provides a unique combination of instruments, image management software and a patent-protected architecture that allows image analysis partners such as Visiopharm to offer their applications to the largest and fastest growing installed base (850 systems, including 550 in hospitals and reference labs) of digital pathology customers.
About Visiopharm
Visiopharm is an international technology leader in histoinformatics, covering image analysis, stereology, and data management. Our solutions reduce labor costs, improve productivity, standardize quantitative processes, and produce accurate, traceable, quantitative results for histopathology. Throughout the world pharmaceutical companies, biotech companies, universities, hospitals and contract research organizations successfully use Visiopharm software to obtain scientifically trustworthy data.
About Aperio
Aperio is the leading provider of digital pathology solutions in hospitals, reference labs, and pharmaceutical and research institutions across the world. Today, our affordable and complete product portfolio improves patient care by enhancing quality assurance, delivering more efficient workflows, facilitating access to new and more targeted therapies, and improving pathologists’ skills via lifelong education. Our comprehensive product line features our ScanScope® scanners, Spectrum™ image management (PACS) software, SecondSlide® slide sharing service for pathology, and image analysis tools and services. Aperio’s products are FDA cleared for specific clinical applications, and are intended for research and education use for other applications. For clearance updates and more information please visit http://www.aperio.com.
Contacts:
Tasha Hicks, Aperio, Director of Marketing (760.539.1118; tasha@aperio.com)
Lene Gerlach, Visiopharm, Vice President Business Development (+45 2031 7460; lge@visiopharm.com)
I received a number of responses to my recent re-posting of Digital Pathology Market Shows Sluggish Growth reproduced from Laboratory Economics.
The comments I received ranged from "I told you so" to "Dr. Gown is completely wrong" to "the numbers do not reflect other benefits of digital pathology outside billable revenues" to "this is only for the U.S. market and not reflective of the world's market".
I would agree with all these statements except the first one.
I never saw the CMS data for CPT code 88361. While this is only one measure of adoption, vis-a-vis number of billable tests using this code, it is only reflective of US data. It is a little discouraging at what is "allowed" versus what is "submitted". Not sure how Laboratory Economics extrapolates this data into market value exactly.
This data of course does not take into account other intangible deliverables beyond billable revenues (image analysis), i.e. education, conferences, risk management, "same slide, same time" consultation, and remote pathology services (which actually could have a PC billing component as well).
Those of us with an interest in the technology for use in clinical diagnostics often struggle making the business case for digital pathology, particularly when competing with other needs/interests/resources/ opinions such as cost of scanners versus cost of immunostainers or laboratory information systems which are mission critical elements. Add to that the other needs of a laboratory -- clinical laboratory equipment, reagants, human resources, etc... I could agree with the comment in the story about cost:benefit ratios. The replacement chemistry analyzer, flow cytometer or Coulter counter that help to generate tens of millions annually will win that battle.
Nonetheless, the risk management point I have used to help groups and hospitals make the decision to invest in digital pathology. Whether it is for consults, cases that travel or are sent in or cases with limited material or no tissue block (i.e. frozen sections, cytology, isolated tumor cells on a single slide, etc...), a digital reproduction as an added measure for patient safety remains a useful advocate for the technology and immeasurable value.
People may look at the risk of using of the technology but there are also these use cases where there may be risk without using technology available today.
I do not agree with Dr. Gown's remarks about looking at 100 year old slides. I had the honor and pleasure of looking at slides in the AFIP archive dating back to the 1940s and 1950s for several studies and looking at slides 50 or 60 years old is not easy. I don't think coverslip medium, tissue fixation methods and stains come with a 50-year warranty like home roofs. A number of other pathologist's at other national laboratories would have put a different spin on this. My quote would have been something to the effect that "Digital pathology images are consistent, persistent and efficient". There is nothing that would change this value proposition 100 years from now. This assumes the images are not stored on 5 1/4" "floppies" which you both can't do due to file size or read nowadays due to lack of 5 1/4" drives.
All my college term papers, first resume and med school application essay are on 5 1/4" disk. I really miss my Radio Shack TRS-80...
Anyways, 10 years ago several people told me "If it is not glass, you can kiss my a**". Those people now use digital pathology in some way, shape or form or they left medicine to raise their family, sell furniture or cashed in several years ago on some old stock they had in a computer company named after a fruit but the name escapes me.
Lastly, there seems to be significant interest in the technology outside of the US for a myriad of reasons. While the US has about 80% of the world's pathologists and pathology sub-specialists, we only represent about 5% of the world's population. There are many other markets but the story does not cover government or payor data for the EU, Asia, Middle East or other world regions. For pathology services providers I think this represents potential markets for customers likely in some sort of TC/PC arrangement but would add other billable deliverables (i.e. CPT 88305) to the equation of digital pathology market value. And folks will not wait for formal FDA clearance for primary H&E diagnoses to tap into these markets.
Very nice read by Dr. Holger Lange of Flagship Biosciences in this month's ASCP LabMedicine (subscription required) on regulatory issues in digital pathology. Holger provides a clear overview of the issues pertinent to digital pathology today.
Abstract
Digital pathology is a new technology and industry. Official agencies, including the Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologists (CAP), and the U.S. Food and Drug Administration (FDA), provide little guidance, and manufacturers still have to learn what it means to provide instruments to a clinical laboratory.
With digital pathology now entering clinical laboratories, it is crucial for physicians and laboratory professionals to understand the regulatory requirements and how to best implement them in their clinical laboratories. The goal of this article is to provide those professionals with a comprehensive regulatory overview and a reference framework for their future work in digital pathology.
Read full text or download PDF as LabMedicine (subscription required).
First Smartphones. Now Tablets.
New Survey Results Uncover How Hospitals Like Yours Are Keeping Up
After surveying more than 600 healthcare organizations, we now have a better understanding of how smartphones and tablets are changing the way hospital staff communicate today. In fact, 90% of respondents stated a portion of their staff use smartphones for work-related communications, while 50% use tablets.
Discover other key findings on topics such as:
Learn more about the state of smartphones and tablets in hospitals, as well as the steps your organization can take to keep up with the changes.
Courtesy of Amcom Software
I learn something new from Laboratory Economics every month. According to the most recent October issue, there has only been a 4% increase in billables for CPT Code 88361, the code used for quantitative IHC analysis. Their estimate puts the total US clinical market for digital pathology at about $80 million as below. Perhaps additional FDA cleared algorithms and primary H&E reads will increase use and market value. Still, this number is far short of the billion dollar market that has been touted. To achieve this will we need a CPT code for technical services for slide scanning, hosting, archiving and viewing and is this realistic/achievable? According to Mr. Farmer below costs will likely remain an issue without FDA clearance for primary diagnosis when labs also need to spend resources on essential items such as immunostainers.
Arguably, one of the most significant value adds for digital pathology remains telepathology but I also think more quantitative, reproducible and consistent image analysis compared with manual image analysis will be the other use and financial driver in this market.
Reproduced with permission from Laboratory Economics.
After several years of 10% to 15% annual growth, the U.S. clinical market for digital pathology has lost speed. Medicare Part B carrier spending on CPT 88361 (digital pathology for quantitative IHC) increased by only 4% to $18.9 million in 2010. CPT 88361 is used to bill Medicare for the reading of digital HER2, ER and PR slides from a computer monitor.
Laboratory Economics estimates the total U.S. clinical market for digital pathology is currently about $80 million (or about 4x the size of Part B carrier expenditures on 88361).
Approximately 500 academic medical centers, hospitals and independent labs have a digital pathology system in place. The market leaders are Aperio Technologies and BioImagene (owned by Roche-Ventana). At this point only the Aperio and BioImagene systems have FDA clearance for HER2 scoring. No vendor has received the Holy Grail: FDA clearance to use digital pathology as a primary diagnostic tool.
The lack of FDA clearance for primary diagnosis means no vendor can scale up so that prices can come down, according to Michael Farmer, principal at the IVD consulting firm McEvoy & Farmer (Seattle, WA). “At this point, a digital pathology system costs as much or more than an Xpress or Peloris or a Benchmark Ultra—and yet they are not viewed as being as essential as a high-throughput tissue processor or top-of-the-line IHC system at most of the labs,” says Farmer.
Meanwhile, Allen Gown, MD, chief pathologist at PhenoPath Laboratories (Seattle, WA), believes glass slides will remain the principal media for pathologists for the next 10 years. “No digital image will ever be as efficient for ease of use as a glass slide,” he told pathologists in a presentation at the Med3000-PSA conference in Palm Springs, California, September 21-23. Gown said the biggest problem is the storage of digitized images. “The technology gets obsolete very quickly, but I can still look at glass slides from 100 years ago.” Over time, Gown thinks digital pathology’s principal use will be for telepathology at remote locations and possibly quantification.
Reproduced with permission from Laboratory Economics.
Early detection of certain types of cancer may eventually become as easy as taking a home pregnancy test. That’s the prediction of researchers who are developing a non-invasive early diagnostic test for gastric cancer that would not require a pathologist to assess a tissue specimen. Instead, this test detects biomarkers in the patient’s urine.
Read more at Dark Daily.
Interview of Mike McCormick and Kathy Revoir, speech-language pathologists, brain injury patients, Lucerne Hospital, Orlando, and communication sciences and disorders (formerly communicative disorders) alumni, University of Central Florida (UCF)
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Brain Injury Speech-Language Pathologists - Video
Medical School Pathology, Chapter 5f: Genetic Disorders
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Medical School Pathology, Chapter 5f - Video
This is a day of speech therapy for Ben,3-1/2.
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Speech Therapy - Video
Medical School Pathology, Chapter 6e: Diseases of Immunity
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Medical School Pathology, Chapter 6e - Video
Speech-Language Pathologists job description
Perfect. Another board exam to take.
The American Board of Medical Specialties, or ABMS, recently approved the creation of a subspecialty certification in clinical informatics. The new subspecialty is co-sponsored by the American Board of Preventive Medicine and the American Board of Pathology, and certification in the subspecialty will be available to diplomates of all ABMS member boards.
According to a Sept. 22 press release from the American Medical Informatics Association, "The role of the clinical informatician is to use his/her knowledge of patient care in combination with an understanding of informatics concepts, methods, and tools to
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Macroeconomic pressure, increased governance, organizational changes, and technological advances are driving pervasive and lasting changes in the fabric of the healthcare system. Because diagnostic services influence the majority of healthcare decisions, changes to healthcare are magnified in the diagnostic services segment. Failure to aggressively adapt to this dynamic environment can easily imperil diagnostic service providers.
The system of record and the lifeblood of diagnostic service providers is the Revenue Cycle Management (RCM) system. A dramatic rethinking of the role of RCM systems is critical to ensuring service providers are able to successfully compete in the marketplace.
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Table of Contents
Introduction — Page 3
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-Interoperable — Page 14
-Informative — Page 15
-Intelligent — Page 15
-Intantaneous — Page 16
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Validating Whole Slide Imaging Systems for Diagnostic Use in Pathology
FREE PHC Webinar
Wednesday, October 12, 2011
11:00 AM – Noon (CDT)
Speaker: Liron Pantanowitz MD, FCAP
Validation of WSI is crucial to ensure that diagnostic performance based on digitized slides is at least equivalent to that of glass slides and light microscopy. The CAP Pathology and Laboratory Quality Center convened a non-vendor panel from North America with expertise in digital pathology in order to develop recommendations for validating WSI systems.
This webinar will cover the background rationale and supporting data used to develop 13 recommendations formulated by the panel. The final result of this effort is intended to improve the clinical use of WSI technology in pathology by providing assurance that these digital tools are being properly used for their intended clinical use, thereby reducing the potential risk of misdiagnosis attributed to this technology.
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BRANFORD, Conn., Oct. 6, 2011 /PRNewswire/ -- HistoRx, the leader in quantitative immunohistochemistry, advances its proprietary position in digital pathology through the recent issuance of US patents covering key features necessary for achievement of reproducible, standardized image analysis results. The U.S. Patent and Trademark Office has granted two new patents protecting the company's methods for standardization of digital microscopy instruments, methods required to generate high-quality reproducible clinical diagnostic data that precisely relates to biomarker concentrations in tissue sections.
For patient tissue specimens stained for a biomarker such as HER2, HistoRx believes that physicians and patients expect the same quantitative result regardless of the digital microscopy instrument used. To achieve this, HistoRx evaluated sources of variability in digital scanning microscopy instrumentation that affect results. One source of variability is the light source; a second is the path traveled by the light through each instrument. By correcting for each of these, HistoRx achieved exceptionally high levels of reproducibility for an assay previously thought to be incapable of true standardization: with AQUA® technology, the same slide of breast cancer specimens stained for HER2 analyzed across five instruments standardized by this method attained a coefficient of variance of less than 5% (where typical variances are ~20%).
"These patents reinforce the value of HistoRx's unique approach to achieving objectivity and reproducibility in anatomic pathology," said Mark Gustavson, Ph.D., Director of Operations at HistoRx and one of the inventors. "You cannot have clinical accuracy without analytical precision."
US Patent 7,978,258, issued to HistoRx on July 12, 2011, is entitled "Automatic Exposure Time Selection for Imaging Tissue" and pertains to methods for determining appropriate exposure time for acquiring digital images intended for image analysis to generate quantitative results. Exposure times are most commonly determined to optimize contrast and visual appeal of the image, and may be determined 'by eye.' The human eye is a poor judge of intensity, and images generated by conventionally determined exposure times are commonly too overexposed for generating quantitative results. The patented methods automatically determine the appropriate exposure time to maximize for a broad range of pixel intensities in the image, thereby maximizing the dynamic range of quantitative measurements achievable from subsequent image analysis.
US Patent 8,027,030, issued to HistoRx on September 26, 2011, is entitled "Methods and System for Standardizing Microscope Systems," and pertains to hardware that can be inserted into the digital imaging fluorescent microscopy system, similar to filter cubes used in fluorescence microscopy, and provides for the monitoring of the light source and its fluctuation.
AQUA technology is an automated, quantitative IHC testing method that enables measurement of protein biomarkers in tissue as an aid to a pathologist's diagnosis. Such precise determination of first, the location within the tumor cell and second, the amount in each location is not possible with conventional testing methods, such as standard immunohistochemistry (IHC). AQUA analysis is used in cancer research by twenty leading academic centers worldwide, is part of the clinical development plans for more than ten drug candidates from major pharma companies, and has been cited in more than 90 peer-reviewed publications. The first use of AQUA technology in the clinical diagnostic setting occurred in 2010 with the launch by Genoptix Inc. of diagnostic tests based on AQUA technology licensed from HistoRx. AQUA technology is currently available on the ScanScope FL™ from Aperio and will be available later this year on the Vectra™ system from Caliper Life Sciences.
About HistoRx, Inc.
HistoRx, Inc. is the leader in quantitative immunohistochemistry and a leading developer of tissue-based diagnostic solutions to advance individualized patient care. The company's products and services are based on proprietary analysis of tissue biomarkers using AQUA® technology. AQUA® technology is the only platform capable of precisely measuring protein biomarker concentration with sub-cellular resolution in tissue sections, enabling fully objective, standardized, reproducible, and automated analysis to guide drug development and therapeutic decision-making. HistoRx is commercializing a pipeline of proprietary diagnostic products targeting improved treatment decision-making and patient outcomes in cancer care. For more information, please visit http://www.historx.com.
SOURCE HistoRx, Inc.
Medical School Pathology, Chapter 7i: Neoplasia
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Medical School Pathology, Chapter 7i - Video
Ultrasound of the Shoulder, specifically the Supraspinatus tendon. Normal and abnormal images and also discription of the import Biceps Tendon in relation to the Supraspinatus Tendon.
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Supraspinatus Pathology - Video
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