Digital Pathology Blog

New distributorship announcement: Aperio

Genecompany is now the sole distributor for Aperio in Hong Kong and China.

We’re pleased to inform that Genecompany is now the authorized distributor for Aperio in Hong Kong and China. With this agreement, Genecompany now offer our customers the Aperio‘s products which are the only complete solution for digital pathology over the world.

Read more.

Courtesy of Gene Company.

Farewell Walter Reed Hospital

After more than 100 years of active operations, Walter Reed Army Medical Center lowered its flag for the last time as activities transition to the newly constructed Walter Reed National Military Medical Center in neighboring Bethesda, MD.

The hospital was known for both treating U.S. presidents and high ranking military and civilian officials and scandal alike. 

I first went to Walter Reed in 1995 as a senior medical student to do a rotation in pathology and check out the program and area as possible site of my residency training.

Truth be told, I wanted to go to Hawaii, California or Colorado where there were active Army hospitals with pathology residency programs.  By the time I finished medical school and internship, those programs were closed.

Walter Reed was one of the Army pathology programs that remained and we stayed at Walter Reed for 9 years were I completed my internship, residency and had my first job in practice.  

Some of the best years of my life, personally and professionally, although I don't think I appreciated it at the time.  The day I started "clearing post" was the day the BRAC list come out with Walter Reed's name on it.  6 years later, much like AFIP as well which was an installation on the Walter Reed campus, has closed down its operations.  

 

What military medicine offers trainees and physicians is a camaraderie and sense of group effort that is hard to match in civilian medicine.  Within the military healthcare system you were able to practice medicine.  No asking permission from insurance companies for approvals, no reimbursement issues that directly impacted you or issues with hospital contracts, payers, payees, etc... Nevermind you were fortunate enough to take care of soldiers, sailors, airmen, marines -- people charged with defending our country at times with personal sacrifice and taking care of their families who counted on these individuals to be safe from harm.

Hard to imagine people actually told me ten years ago the government would never close Walter Reed or AFIP.  

Times change.

 

 

What if the cure for cancer were discovered tomorrow?

There is a quote I heard or saw a number of years ago that says something like "Medicine, the only profession that labors incessantly to destroy the reason for its own existence".

Recently ESPN went through a telethon for the Jimmy V Foundation and the ESPY awards and celebration always receive mention of Coach Jim Valvano and his famous "Never Give Up" speech.  

Occasionally, I think of Dr. Randy Pausch and his "Last Lecture" speech.  

These men and countless others, both patients, families, friends and providers have strived to raise money to find cancer cures.  

What if the cure for cancer were discovered tomorrow?  And the efforts of tens of thousands of volunteers, researchers, organizers, physicians, politicians, deans and bureaucrats saw to it that a cure could be found.

Of course, one of the reasons a cure for cancer has not been discovered despite countless hours and trillions in funding worldwide is that cancer is not a single disease, it is very heterogeneous, even among cancers that involve the same organ or organ system.

For the sake of argument what if the cures for colon, lung, breast and prostate cancer were discovered tomorrow?

How long would it be before the cure was validated by groups outside those making the initial claim and the product brought to market?  

Would the cure treat only those diagnosed with the disease or could it be taken to prevent the disease?

Ask this question of anyone in passing (at least for me when I talk to folks in healthcare, laboratories, fellow pathologists) and you will hear "I would be out of a job".  But would they?  

What would a cure do to the economics of healthcare as it pertains to oncology diagnostics, therapeutics, oncologic surgery, radiation and management of known complications of the disease and its treatments? 

What effect would the saved lives that may have been lost due to population statistics and what impact would that have on other diseases and medical specialties?  Fewer oncology visits may mean increased cardiology referrals as one example. Would it be too late for me to do a cardiology fellowship?

Future posts will try to tackle some of these hypothetical scenarios based on known facts, figures, costs and population models.  If you know of any good sources, please let me know.

 

 

Indica Labs extends In situ hybridization capabilities with automated quantification of dual ISH assays

Albuquerque, New Mexico 7/26/2011 – Indica Labs, inc. announces new capabilities for measuring dual ISH assays for the purpose of measuring gene amplification in tumors and other tissues. The new, fully automated and quantitative solution allows researchers and pathologists to measure dual ISH assays, such as those provided by leading reagent manufacturers, with the single click of a button rather than having to manually count spots which is an arduous process. The software rapidly counts dual probe signals and reports ratios between probes on a per cell basis. This automated approach is not only faster and less error prone than manual interpretation of the assays, it also generates additional data such as signal ratios and signal counts at the cellular level in addition to the specimen or tumor level data. This additional level of detail is useful in measuring the cellular heterogeneity within tumors. Indica Labs, CEO Steven Hashagen stated:

“We are excited about expanding our ISH quantification capabilities. The use of brightfield ISH assays is increasingly becoming more main-stream and image analysis software dramatically simplifies the work involved for scoring these assays. Moreover, the use of dual ISH kits makes image analysis quantification even more of a necessity than before.”

This latest release of Indica's ISH software is highly configurable such that it can be used to measure a wide range of reagent kits, tissue types, and image file formats. Prior to this announcement, Indica Labs’ product offering included several other tools for measuring just single probe CISH, SISH, and RNA ISH assays. To learn more about any of the ISH quantification products visit http://indicalab.com/products.html. Additionally, Indica Labs and Aperio presented all of these capabilities in a complementary webinar that aired on July 21st. To view a recording of the webinar, visit http://www.aperio.com/pathology-events/webinar_events.asp.

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About Indica Labs, Inc.

Indica Labs provides sophisticated pathology image processing software for whole slide tissue analysis. Indica Labs' software tools seamlessly integrate into leading digital pathology platforms to provide reproducible and highly quantitative data to pathologists in hospitals, academic medical centers, government research institutions, global pharmaceutical companies, and small biotech firms. For more information, please visit www.indicalab.com. Indica Labs products are intended for research use only.

 

Contact

Indica Labs, Inc. info@indicalab.com

 

 

PathXL Performance Acceleration - Upgrade For All PathXL Users

i-Path is pleased to introduce improved performance for PathXL platform, available to all customers from the 20th July 2011.  This upgrade will bring noticeable benefits for i-Path customers who use PathXL for research, education and clinical purposes.

The PathXL acceleration integrates with the PathXL Image Server to speed up the delivery of digital images.  From 20th July 2011 images will be provided to the customer using a faster network connection (gigabit) and intelligent algorithm compression techniques.  Current PathXL users will experience noticeable improvements,  with instantaneous image viewing on suitable bandwidth networks.

All i-Path hosted customers will benefit immediately from this upgrade with no additional effort required from the side of the customer.

Please contact the i-Path Support Team for more information.

 

MikroScan Achieves Groundbreaking Footprint in Desktop Whole Slide Scanner for Digital Pathology

Courtesy of the San Francisco Chronicle via PRWeb

Vista, CA (PRWEB) July 22, 2011

Whole slide imaging (WSI) manufacturer, MikroScan Technologies, Inc., announces a breakthrough in size threshold of its ultra-small desktop whole-slide scanner, the MikroScan D2, which is designed for secondary diagnostic analysis and collaboration for digital pathology, clinical research, and education applications.

With workspace at a premium shortage in most laboratories, MikroScan has focused its design and development on instrumentation that innovates the advanced features of larger more expensive systems into smaller desktop, or "personal," scanning solutions. A few minor changes on the inside have created a stunning difference on the outside, and now the market's smallest whole-slide scanner is dramatically smaller.

The tiny desktop footprint of the MikroScan D2 is now only 11 by 13 inches (143 square inches) - a whopping 40% smaller footprint area than the previous version, which was 13 by 18 inches (234 square inches).

"It's about the size a shoe box," says Bob Goerlitz, president of MikroScan Technologies. "We've been working on these improvements for a while, and we are very excited to bring them to market. This type of design criteria has been our core value since launching the company. The goals have been simple; to provide the market with a scanner that meets the end-users' needs for features, capability, and price so the market will finally be able and willing to support and adopt cost-effective digital pathology technology."

The new, more compact MikroScan D2 still packs all the same powerful features and performance that pathologists are calling for, including excellent quality imaging, high-resolution scan speeds well under 2 minutes, and collaborative communications tools that allow remote sharing and control. The scanner is ideal for frozen section room, and cytology fine needle aspiration (FNA) cart applications.

Victor Casas, chief technology officer and applications specialist at MikroScan Technologies, said, "Nothing was sacrificed in the minor reengineering to achieve a smaller footprint. If anything, we have made further improvements to the solid design, increased overall accuracy, and enabled some features that were previously unused. The optics and imaging system are the same exceptional quality, which is a pathologist's main concern for quality medicine and diagnostic accuracy."

"The new smaller sized instrument will make a huge difference for a lot of pathology offices and laboratories where workspace is scarce," said Mr. Goerlitz. "People are quite shocked when they first see how small it is. They are even more amazed when they see first hand the superior image quality it produces and how its features, performance, and flexibility can dramatically improve their workflow and diagnostic communications, and allow end users to bridge the gap between digital slide scanning and remote telepathology. The MikroScan D2 is clearly the smallest, yet most advance scanner in its class."

Mr. Goerlitz was previously quoted, "In large facilities, our solution complements the high-throughput products on the market by filling in the 'gaps of convenience' through eliminating issues like consult travel time, lab wait time, slide shipping time, and of course MikroScan's small footprint allows easy operation from anyplace with Internet access including your desk, lab, frozen section room, or office."

About MikroScan Technologies, Inc.

MikroScan Technologies, Inc. founders have been engaged in the design, sales, and marketing of high quality laboratory instruments for more than 26 years. The company specializes in the development of cutting edge whole-slide imaging (WSI) systems and diagnostic communication tools designed for pathology, biology and research applications. With game changing technology and pricing, MikroScan products represent a leap in advancement and convenience in the evolution of WSI and digital pathology. MikroScan centers its product development on three primary criteria: 1) Speed of slide image acquisition: necessary to make scanning technology practical in scientific investigation and clinical applications. 2) High quality slide images: necessary for accurate visual or digital diagnostics and or collaboration. 3) Affordability: unprecedented economics that allows scanners on anyone's desktop or lab workstation. For further information visit: www.MikroScan.com

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For the original version on PRWeb visit: www.prweb.com/releases/prwebsmallest-whole-slide-scan/digital-pathology-imaging/prweb8662022.htm

Read more: http://www.sfgate.com/cgi-bin/article.cgif=/g/a/2011/07/22/prweb8662022.DTL#ixzz1SwabUfyY

FDA Releases Draft Of Mobile Health App Guidelines

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."

 

 

How Should Personalized Medicine & Digital Pathology Work Together?

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.

 

FDA seeks comments on proposed policy for companion diagnostics

(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. 

How Internet-Based Lab Tests Access Helps Clinical Laboratories Serve Un-Insured and Under-Insured Patients

FREE Special Edition White Paper

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Internet-based companies that provide consumers with access to lab tests provide a significant and highly valued service for patients, particularly for those patients who are uninsured and underinsured.

The companies also provide services for patients who have high deductible health insurance plans and for any patients looking to keep the cost of lab tests low. Typically, patients who are fully insured do not need to the services of Internet-based companies that provide consumers with access to lab tests because their lab tests are paid in full by third-party insurance  company or these patients are required to pay only a small co-pay or coinsurance at the time of service.

The Dark Report is happy to offer our readers a chance to download our recently published FREE White Paper “How Internet-Based Lab Tests Access Helps Clinical Laboratories Serve Un-Insured and Under-Insured Patients” at absolutely no charge. This free download will provide readers with a detailed explanation on how these services work and the benefits these companies provide to the uninsured, the underinsured, and those with high-deductible health insurance. This report also will outline the value of transparency in healthcare pricing and how price transparency helps physicians in Ohio provide better patient care for the uninsured and underinsured.

—

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