Digital Pathology Blog

FDA Nanotech Role Outlined

The US Food and Drug Administration (FDA) should consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology, according to a report released by the FDA Nanotechnology Task Force on July 25.

Nanoscale materials could potentially be used in most product types regulated by the FDA, and those materials present challenges similar to those posed by products using other emerging technologies, according to the report.

"The challenges, however, may be complicated by the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale," the FDA said in a statement.

The task force also said the emerging and uncertain nature of nanotechnology and the potentially rapid development of applications for FDA-regulated products highlight the need for ensuring transparent, consistent and predictable regulatory pathways.

Anticipating the potential for rapid development in the field, it recommends consideration of agency guidance that would clarify, for example, what information to give FDA about products, and when the use of nanoscale materials may change the regulatory status of particular products. As with other FDA guidance, draft guidance documents would be made available for public comment prior to being finalized.

In addition, the task force said the FDA should work to assess data needs to better regulate nanotechnology products, including biological effects and interactions of nanoscale materials. The agency should also develop in-house expertise and ensure consideration of relevant new information on nanotechnology as it becomes available, according to the report, and it should evaluate the adequacy of current testing approaches to assess safety, effectiveness and quality of nanoscale materials.

"Nanotechnology holds enormous potential for use in a vast array of products," said Commissioner of Food and Drugs Andrew von Eschenbach, MD, who endorsed the task force report and its recommendations on July 23. "Recognizing the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials."

Scientists and researchers increasingly are working in the nanoscale, creating and using materials and devices at the level of molecules and atoms—1/100,000th the width of a human hair.

The FDA Nanotechnology Task Force Report on Nanotechnology addresses regulatory and scientific issues and recommends FDA consider development of nanotechnology-associated guidance for manufacturers and researchers. The task force was initiated by von Eschenbach in 2006.

The FDA and 22 other federal agencies are part of the National Nanotechnology Initiative, a federal research and development program established to coordinate the multi-agency efforts in nanoscale science, engineering and technology.

For the most part, FDA experts believe that nanotechnology products present challenges similar to those FDA faces for products of other emerging technologies, the agency said. "FDA experts recognize, however, that product safety and effectiveness can change as size goes up or down within the nanoscale, adding additional complexity to the product review.  It’s also possible that nanotechnology will be used in a wide variety of products, such as foods, drugs, cosmetics and medical devices.

"Nanotechnology is currently used in such fields as display technology for laptop computers, cell phones and digital cameras, and in water filtration," the FDA said. "And nanomedicine is an area of biomedical research that seeks to use nanoscale tools to improve health.

"Current medical uses of nanotechnology include burn and wound dressings, a dental-bonding agent, sunscreens, protective and glare-reducing coatings for eyeglasses. Some day, you may see nanotechnology used in food packaging to further extend shelf life or used medically to provide new drugs that are able to reach sites in the body more effectively and at safer doses, to create tiny sensors that detect diseases in the body far earlier than existing diagnostic tools, or to manufacture incredibly small pumps that can be implanted to deliver lifesaving medications precisely to the cells and tissues that need them," the agency said.

The FDA said it expects that many of the nanotechnology products it will regulate will span the regulatory boundaries between drugs, medical devices and biologics. These would be regulated under the rules established for "combination products," it said.

The task force report is available at: www.fda.gov/nanotechnology/taskforce/report2007.html

Digital Images of Case Reports and Other Articles in International Journal of Surgical Pathology

From Dr. Juan Rosai, Editor, IJSP

As already announced in previous issues of the journal (“New Editorial Policy for the Publication of Case Reports”) and further specified in the “Instructions to Authors” notice, most articles published in the “Case Reports” section of the journal and some from other sections will have an added feature that we believe will greatly enhance their interest. Those articles will be identified by the icon DI (standing for Digital Image) in the Table of Contents and in the title page. In addition to the conventional printed photomicrographs that will accompany each article, readers will be able to view the digitally scanned image of the entire microscopic slide(s) of the case by following this procedure:

1. Go to Website www.onlinetelepatologia.com

2. Go to Galleria. You will be asked for User ID and Password. Type on both fields the word guest;

3. Click on IJSP folder and go to listview (upper right hand window). You will see a listing of the articles having scanned images, identified by the volume, initial page number and year of publication written on the slide label(s);

4. Click on the desired case to view it. If necessary, follow instructions on the use of the program by clicking the Help green button. This feature will be made retroactive, in the sense that it will include some of the cases published in past issues of the journal. In an effort to make the list as complete as possible, authors of Case Reports published before the current issue will be invited to submit representative slides from their cases in order for them to be incorporated into the file. Those articles selected prior to this issue will not be identified by the icon DI, and therefore any reader interested in seeing whether a digital image exists for it will have to search for it in the chronologically arranged database.

All the cases have been scanned with the ScanScope CS, manufactured by Aperio Technologies. The scanning has been carried out at Milestone SRL (www.milestonemedsrl.com), a company based in Bergamo, Italy, which manufactures microwave units for rapid histoprocessing and instrumentation for macro digital imaging for grossing procedures. One of the company’s main goals is to provide pathologists with innovative tools to enable sameday diagnostic results. Their generous sponsorship of this new feature of the journal is greatly appreciated.

Web Page Discussed Bringing Medicaid and Home Telehealth Together

Can home telehealth help Medicaid recipients have better success receiving the regular healthcare that they need? The question is addressed in the newest installment of the Home Telehealth Community of Care web page entitled “Medicaid and Home Telehealth: It’s Time.” The information was produced by Information for Tomorrow and is available at www.informationfortomorrow.com/community/Medicaid.htm.

Excessive costs of more than $300 billion annual for the 50 million plus Medicaid enrollees is a good reason to look at alternatives or adjuncts like home telehealth. Technology is working best now with large populations needing frequent contact and management for their multiple chronic diseases and conditions. At this time, 83% of the Medicaid budget is devoted to persons living with chronic diseases and other conditions like diabetes, heart disease, and respiratory conditions.

The web page provides details on the burgeoning expenses of Medicaid patients in the “Medicaid Pays” segment, along with details on the handful of states where Medicaid programs are leading the way to trying different and much needed new approaches.

Also on the site, Kim Anderson, RN and CEO, Rural Health Advantage in Chariton IA provides a broader view on the specifics that are needed to understand the value for keeping the long term Medicaid population well and at home using telehealth. She provides details on how Medicaid funding was established in Iowa.

The Home Telehealth Community of Care Information web page is continually updated and developed by Information For Tomorrow, a telehealthcare company specializing in research on home telehealth tools and applications. According to Research Director Audrey Kinsella, this quarterly web page provides the opportunity to keep current and get targeted information in selected topics in the area of home telehealthcare.

For more information, email telehealthcare@lycos.com or call 828-252-8571.

MRIs most effective at spotting breast cancers in high-risk women, study suggests.

HealthDay reports, "MRIs caught more breast cancers in women at high risk for the disease than either mammography or ultrasound," according to a study in the August issue of Radiology. In the study of 171 "high risk" women -- those with either the BRAC 1 or BRAC 2 gene mutation or a family history of the disease -- "MRIs found all six of the breast cancers detected, while mammography spotted only two, and ultrasound found just one."
MedPage Today adds that study author Dr. Constance D. Lehman writes, "Although the specificity of MRI was lower than that of mammography or clinical breast examination (89.8%, 95.0%, and 98.1%, respectively), the overall accuracy of MRI was significantly higher." Study participants "were screened for breast cancer with MRI, mammography, and ultrasound, with no more than 90 days between each screening test." MedPage continues, "Dr. Lehman and associates concluded that their study further supports MRI 'as an important complement to mammography in screening women at high risk for breast cancer.' They acknowledged, however, that their study was small, did only a single round of screening, and did not include long-term follow-up."

Cities Buidling Wi-Fi Networks Are Running Into Hurdles

Interesting article from The Wall Street Journal last week (8/16/2007)

(Reproduced)

Wireless -- With Strings Attached

Cities Buidling Wi-Fi Networks Are Running Into Hurdles, Including Mounting Costs

by Amol Sharma

In recent years, dozens of U.S. cities and towns have announced plans to build Wi-Fi networks that would give their citizens a cheap and convenient way to access the high-speed Internet and provide new competition to phone and cable companies.

Now some of those projects are running into hurdles. Constructing networks that can provide Internet access to homes and office buildings and withstand challenges from nature that interfere with wireless signals -- such as hills or rainstorms -- is proving more costly than anticipated. Some Wi-Fi projects, such as Philadelphia's, are running 30% or more over budget. Many cities are discovering the true costs of the initiatives only as they begin to roll out infrastructure and test the networks. Consumer demand for the services, meanwhile, has been soft in the early going.

Companies such as EarthLink Inc. and MetroFi Inc. have been increasingly taking the lead on building and operating these networks for cities. But as the economics of the industry get tougher, the companies are asking cities to bear more of the financial burden, either by contributing cash toward construction or by agreeing to purchase Wi-Fi services for government workers.

"This is a new and emerging industry, and the business model is still evolving," says MetroFi Chief Executive Chuck Haas. Mr. Haas says MetroFi, which specializes in designing and building Wi-Fi networks for metropolitan areas, now requires cities to contribute a substantial amount of capital before agreeing to new projects.

It isn't just financial issues that are plaguing Wi-Fi initiatives. In San Francisco, an array of politicians and civic groups have criticized the city's deal with Google Inc. and EarthLink, primarily a provider of landline Internet access, to create a Wi-Fi network. The critics cite privacy concerns, poor economics for the city, and even the potential that radiation from Wi-Fi equipment could have harmful health effects. Following a standoff with the city's board of supervisors, the mayor, who had proposed the idea of a citywide Wi-Fi network, placed the issue onto a November ballot.

An EarthLink spokesman said the company remains in discussions with the city on how to move forward with the project.

"We continue to hope that EarthLink and the City of San Francisco will find a way to enable all its residents to enjoy the free Wi-Fi network they deserve," said a Google spokesman. "We believe that ballot initiative is a great opportunity for San Franciscans to express their support for free wireless access for all."

The municipal Wi-Fi movement is far from dead. More than 90 cities and towns, including Portland, Ore., Corpus Christi, Texas, and others, have already launched service, according to MuniWireless.com, a Web site that tracks the projects nationally. Nationwide spending on municipal Internet projects was $236 million last year, up from $117 million in 2005, and is expected to nearly double this year, the organization said. Wi-Fi technology, generally, is gaining popularity. Consumers are increasingly accessing the Web at hotspots like coffee shops and airport lounges. And they are doing so not just from laptops, but also from new mobile devices like Apple Inc.'s iPhone.

But municipal networks aren't on track to offer consumers a cheaper high-speed alternative to the powerful U.S. phone and cable companies, as some backers once envisioned.

Proponents of municipal wireless networks say cities and Wi-Fi companies are learning lessons from the early setbacks and are adapting.

Initially, cities funded their projects out of their own budgets. That proved controversial, as telecom operators argued that it smacked of the government competing with the private sector. Now many cities are contracting out the work of building and operating the networks to companies like EarthLink and MetroFi, who team up with Wi-Fi equipment providers like Tropos Networks Inc., Motorola Inc. and BelAir Networks. In many cases, the only thing cities are offering the companies in such deals are the rights to hang hundreds or thousands of small Wi-Fi transponders on public property such as lightpoles and traffic lights.

That model isn't holding up. The Wi-Fi companies envisioned being able to offer subscription service to consumers at rates that were significantly cheaper than phone and cable broadband. But the unexpectedly high costs of building Wi-Fi networks -- the price tag can easily run into the tens of millions for a big city -- coupled with lower prices for broadband from some phone companies, has made it tougher for consumer Wi-Fi to be competitive. For example, EarthLink offers Wi-Fi for about $20 a month, a price that is on par with the lower-end Internet services now offered by AT&T Inc. and Verizon Communications Inc.

At the end of the second quarter, EarthLink had only about 4,000 subscribers from its rollouts in Philadelphia, Anaheim, Calif. and Corpus Christi. The company, which is operating under new leadership after the death of former Chief Executive Garry Betty early this year, said in late July it would pull back on further investments in Wi-Fi until it negotiates better deals with cities. In particular, the company wants a commitment by cities to become a significant customer, or "anchor tenant," and thereby guarantee EarthLink a steady revenue stream. "The Wi-Fi business, as currently constituted, will not provide an acceptable return" for EarthLink shareholders, said newly installed Chief Executive Rolla Huff on a recent conference call with analysts.

Mountain View, Calif.-based MetroFi has also signaled that it is only interested in projects where cities are a major customer. While the company has faith in its model of providing free Internet service to consumers supported by ads, that model "has to work in conjunction with other revenue streams," Mr. Haas says.

Esme Vos, who runs the MuniWireless site, says the pressure on cities to use the networks for government services is healthy. "It forces the cities to sit down and think about what they want to do with the networks," she says. "They actually have to come up with a business plan."

In many cases, says Ms. Vos, public-safety workers are a natural user base. Policemen could use the service to download mug shots of suspects in their vehicles, while firefighters could get blueprints of burning buildings. In some cases, Wi-Fi could be used to let government workers telecommute.

Some big cities, like Minneapolis, are already signing those kind of "anchor-tenant" agreements. But for many cities with tight budgets, bearing costs for the projects isn't easy. In July, the city of Anchorage, Alaska pulled out of its deal with MetroFi after the company demanded the government pay a fee for network usage. Toledo, Ohio originally awarded its contract to MetroFi and agreed to put in financing worth $4.3 million. MetroFi would offer consumers free Internet service supported with ads and provide access for public safety workers. But some local politicians and citizens balked at the deal, saying the city couldn't afford it.

Now, the Toledo plan is being reworked. Todd Davies, Toledo's commissioner of development, says the new proposal would reduce the city's contribution to $1.5 million by tapping resources already budgeted to public-safety agencies and taking advantage of a federal grant the city has received from the Department of Homeland Security. The city council still has to approve the plan.

Craig Settles, a consultant to cities and companies on municipal-wireless initiatives, says cities that are just now drawing up plans for Wi-Fi are doing so more cautiously. Mr. Settles is advising Glendale, Calif., on its project. Before the city issues a request for proposals from bidders, it is conducting a study to determine which businesses, government workers, and members of the medical community could use the network. The goal is to make sure there will be demand for the Wi-Fi service before the city commits to anything.

"The cities that didn't join the rush last year are taking it slower and are being much more thorough in their analysis," Mr. Settles said.

Real-time elastography accurately detects prostate cancer

Real-time elastography accurately detects prostate cancer in men scheduled for radical prostatectomy, according to a report in the July BJU International.

"Elastography is a contrast-media-free technique, which allows for detection of suspicious areas in the outer gland," Dr. Leo Pallwein from Medical University Innsbruck, Austria told Reuters Health. "It has the potential to become a reliable screening tool in men with elevated PSA."

Dr. Pallwein and colleagues assessed the value of elastography for detecting prostate cancer in 15 men scheduled for radical prostatectomy.

Elastography detected 28 of 35 cancer foci (80% sensitivity), the authors report, but missed 7 foci, most of them in the inner gland or in the basal area of the outer gland.

The only four sites with false-positive findings were obtained in the first five patients, the investigators say, "while gaining experience with the technique."

There was no correlation between PSA levels, Gleason scores, and elastography results.

"Elastography needs some weeks to overcome the learning curve, but this technique can be helpful in detecting cancer without use of contrast agent," Dr. Pallwein said.

"Elastography is successfully used for cancer detection in the prostate, thyroid gland, breast, and pancreas," Dr. Pallwein explained. "Further technical developments can improve and establish this technique in the daily routine examination."

BJU International 2007;100:42-46.

Reminder for Aperio Pathology Visions 2007 Conference

Aperio and California Society of Pathologists to Host Third Annual Pathology Visions Conference

Digital Pathology Program to Feature Pathology Leaders from Intermountain Healthcare, Novartis, Quest Diagnostics, and GE Healthcare

Vista, CA  August 13, 2007 - Aperio Technologies, Inc., (Aperio), a global leader in digital pathology for the healthcare and life sciences industry, and the California Society of Pathologists (CSP), a non-profit professional organization representing pathologists, invites interested pathology professionals to join them for the third annual Pathology Visions conference to be held October 21-23 in San Diego, CA at the Hilton San Diego Resort Hotel. The Visions conference is focused solely on digital pathology and brings together attendees from around the world to share best practices and learn about a range of topics related to the rapidly growing digital pathology market. This year's conference features three concurrent tracks focused on topics that include clinical, image analysis and research, education, and IT and implementation.

Dr. Elizabeth Hammond of Intermountain Healthcare will serve as keynote speaker, presenting "Digital Imaging: Role in Distributed Pathology Practice and Education." Dr. Hammond was named the 2005 Pathologist of the Year by the College of American Pathologists, and is recognized as one of the Foremost Women of the Century and Best Doctors in America.

Pathology Visions offers attendees the opportunity to network with peers and nationally respected experts in healthcare, learn about cutting-edge digital pathology products and solutions from leading vendors in the exhibit hall, access digital pathology “test drive” stations, and attend two days of multi-track educational sessions and panel discussions covering the latest topics in digital pathology. Featured speakers from the pathology industry will include:

Dr. Jared Schwartz, CAP Foundation, presenting "Future of Pathology: Vision 2020"

Maher Albitar, Quest Diagnostics Nichols Institute, Medical Director Hematopathology, presenting "Measuring Angiogenesis in Hematologic Diseases"

James Deeds, Novartis, presenting "Customizing Spectrum Plus in a Pharmaceutical Research Pathology Environment"

Giri Iyer, General Manager, Strategic Development, Integrated IT Solutions, GE Healthcare, presenting "Digital Pathology Healthcare IT Visions - A GE Perspective"

Alfred Lui, President of the CSP commented, "We are honored to be co-hosting Pathology Visions with Aperio. The CSP recognizes the potential impact digital pathology will have on our profession. We are pleased to participate in a conference dedicated to digital pathology and designed for pathology professionals of all types."

"We are delighted to have such a distinguished group of speakers,"stated Dirk Soenksen, CEO of Aperio. "The digital pathology market is currently in a phase of rapid growth. By bringing together thought leaders, users, and vendors, the Visions conference provides a stimulating forum for assessing progress, and learning about the future of digital pathology. We are pleased to be co-hosting this event with the CSP."

A European conference is also scheduled December 3-5, 2007 in Amsterdam. For registration, exhibitor, or sponsorship information, please visit pathologyvisions.com or aperio.com.

Aperio provides systems and services for digital pathology. Our award-winning ScanScope® slide scanning systems and SpectrumTM digital pathology information management software is helping pathology professionals around the world improve the efficiency and quality of pathology services, enhance patient care, and improve the bottom line. Applications include remote viewing, archival and retrieval, digital slide conferencing, research and education, and image analysis. For more information and to view a gallery of digital slides created by ScanScope Systems, visit www.aperio.com.

ASCP Launches Phase II of Stop Pod Labs Campaign

From the ASCP

ASCP Launches Phase II of Stop Pod Labs Campaign

The American Society for Clinical Pathology (ASCP) strongly supports the Centers for Medicare and Medicaid Services' (CMS) framework for its proposed physician fee schedule (PFS) for 2008, but the Society believes it may be necessary to enhance the rules in several areas. ASCP scored a significant victory when CMS released the proposed PFS on July 12, as the Agency recommitted itself to preventing the potential for billing abuses by "pod labs" and other arrangements using contractual joint ventures that markup the cost of anatomic pathology services.

Among the areas in the proposed PFS still in need of revision are the proposed rules regarding the definition of a full-time employee of the billing physician or group practice performing the Technical Component (TC)/Professional Component (PC). ASCP seeks to ensure that the employee would be a bona fide full-time employee working exclusively for the billing entity as proposed by CMS last year. ASCP is a strong and persistent supporter of CMS's 2006 proposal to eliminate the potential for abuse of the Medicare reassignment and self-referral provisions.

In addition to meeting directly with CMS officials and Congressman Pete Stark, Chairman of the House Ways and Means Health Subcommittee, to urge action, ASCP launched its"Stop Pod Labs Now" campaign, which generated approximately 2,000 letters to Congress asking legislators to push CMS to implement stringent reforms to block potentially abusive billing practices. Phase II of the campaign launches on August 1, 2007. For more details, watch for the August issue of ASCP's ePolicy News, by email Aug. 1 or online at http://capwiz.com/ascpath/issues/alert/?alertid=10115991.

API Advanced Informatics Course at APIII Reminder

Course Description:

This course has been developed by the Association of Pathology Informatics to provide pathologists and medical technologists the information necessary to understand - and lead – a successful LIS implementation.  It will discuss each step of the process – evaluation, selection, implementation and evolution – in detail, and will include the concerns of critical stakeholders including laboratory accreditation groups, enterprise IT and the LIS vendors. After taking this course, Pathologists and Medical Technologists should be much better prepared to guide what is often the most important and expensive informatics project that a practice will face – the selection, implementation and extension of an LIS.

Intended audience:

-          Practicing pathologists who have been asked to be the “Informatics Lead” for their practice or department

-          Senior pathologists who need to think strategically about their practices informatics strategy

-          Practicing pathologists who need to lead, guide or participate in an LIS implementation or upgrade

-          Pathology informaticians

-          Medical Technologists who are project leads for LIS implementations or upgrades

By the end of this session, attendees should:

-          Understand the LIS evaluation process

-          Understand the RFP evaluation process

-          Understand the process of an LIS implementation

-          Understand how to extend LIS functions

-          Understand how to align the LIS with enterprise IT needs

-          Understand regulatory issues surrounding the LIS

-          Understand the concerns of the LIS vendor and other stakeholders in the LIS implementation process

Those interested can find more information and print a registration form at http://www.pathologyinformatics.org/APICourse.htm.

The cost of the course is $175 for API members and $280 for non-members. For those registering for APIII and the course, you can register online at http://apiii.upmc.edu/registration/index.html.

Hope to see you in Pittsburgh.

First Google Health Screenshots

Dr. Victor Brodsky from Mount Sinai Medical Center in New York recently placed this posting on the API listserve.  For readers of the blog who do not subscribe to this - take a look.

"I came across the first screenshots of Google Health and thought I'd pass them along:

http://blogoscoped.com/archive/2007-08-14-n43.html

The service does not look realistic at this point (and seems to be a great way to do target advertising), but a lot of things Google dabbles in end up being used by many people..."

Here is an overview in New York Times: http://www.nytimes.com/2007/08/14/technology/14healthnet.html?ei=5087%0A&em=&en=66c63ffcdb8643a8&ex=1187236800&pagewanted=print

From Google Blogscoped

Google Health, codename “Weaver”, is Google’s planned health information storage program. Google’s Vice President of Engineering Adam Bosworth lobbies for the program for quite a while now. Adam said the current US health care system is challenged when it comes to “supporting caregivers and communicating between different medical organizations.” Adam went on to say that people “need the medical information that is out there and available to be organized and made accessible to all ... Health information should be easier to access and organize, especially in ways that make it as simple as possible to find the information that is most relevant to a specific patient’s needs.” Adam adds that this – making information accessible – happens to be along Google’s mission.