The Daily Scan

chalk tip #39: Aperio FDA clearances

Hi everyone...  it's been a while since my last chalk tip and I'm getting back into the habit :)

I get asked a lot about Aperio's FDA clearances...  people want to understand exactly which applications are FDA cleared, and all the details.  The detailed information on each filing is posted on our website, including links to the corresponding FDA premarket notification database entries.  There are also links to the press releases announcing each clearance.

Here is a list of our current FDA clearances, linked to the details:

• HER2 Image Analysis - K071128
• Manual Read of HER2 Digital Slides - K071671
• ER/PR Image Analysis - K073677
• IHC PR Breast Tissue Manual Read of Digital Slides - K080254
• HER2 Image Analysis for Breast Tissue – K080564

It is important to note that Aperio products are FDA-cleared for specific clinical applications, and are intended for research use for other applications.

Aperio is hiring Product People!

I don't like to post too much Aperio-centric stuff on this blog, but here's something that might be interesting to both of us: Aperio is expanding its product team and we are looking for some key product managers and business analysts.  We presently have the following new positions open:

Product Manager, Life Science
Product Manager, Image Analysis
Business Analyst, Healthcare Solutions
Business Analyst, Life Science

If you or anyone you know is interested in any of these positions, please send an email to jobs@aperio.com.  Thanks!

[Update: I am always amazed to see how fast stuff gets picked up on the Internet.  We just posted these openings on our website, and already they've been echoed far and wide, such as this posting on Startuphire.com.  Aperio isn't a startup anymore but we're happy to have our opportunities widely publicized :) ]

FDA overhauls 510(k) process

HealthImaging reports FDA overhauls 510(k) process:

The FDA issued two evaluations containing recommendations that address three objectives of the agency’s public health mission as it relates to medical devices--foster device innovation, create a more predictable regulatory environment and enhance device safety.

The FDA’s Center for Devices and Radiological Health (CDRH) assessment consists of two preliminary reports. One report focuses on ways to strengthen and clarify a premarket review process called the 510(k) program for medical devices that do not need to undergo a full premarket approval review. The other evaluates CDRH’s use of science in decision-making, with an eye toward adapting to new scientific information, while maintaining regulatory predictability necessary for innovation.

CDRH established two staff committees on these issues in late 2009 as part of its 2010 strategic plan, according to the agency. The committees collected and reviewed input from public meetings, open dockets, data analyses and input from CDRH staff over the course of several months to prepare the complementary evaluations.

Interesting...  we'll all read these reports with great interest, and determine the effect on the FDA's regulation of digital pathology.  Aperio and a number of other digital pathology vendors have FDA-cleared applications, all of which have gone through the FDA's 510(k) process.

Cleveland Clinic Breaks Ground On $75 Million Laboratory

CityNews USA reports Cleveland Clinic Breaks Ground On $75 Million Laboratory:

On July 30, Cleveland Clinic broke ground for a $75 million building to house the hospital’s Pathology and Laboratory Medicine Institute and Cleveland Clinic Laboratories, a project that will improve medical testing capabilities and create hundreds of new jobs. Carnegie Avenue Facility will Create Hundreds of Jobs, Offer State-of-the-Art Testing

The building, which is being constructed near the intersection of East 105th Street and Carnegie Avenue, will be three stories and 135,000 square feet. Currently, the Pathology and Laboratory Medicine Institute (PMLI) employs 1,300 and conducts more than 12 million tests each year.

What an incredible new facility that will be...  can't wait to see it :)

UCLA researchers discover the unexpected cell that causes prostate cancer

Wow, this is cool - the LATimes reports UCLA researchers discover the unexpected cell that causes prostate cancer:

UCLA researchers reported Thursday that they have discovered the identity of the prostate cell that goes awry to produce cancer, a finding that could lead to new approaches to prevention and treatment of this common plague of men. Most researchers had previously believed that prostate tumors originated in the so-called luminal cells because tumor cells look like luminal cells. But immunologist Owen N. Witte of UCLA's Jonsson Comprehensive Cancer Center and his colleagues have found that it actually arises in basal cells, a more stem cell-like component of the gland.

The prostate is filled with a network of small tubules. The insides of these tubules are lined with luminal cells, which produce fluids and proteins that aid reproduction. Basal cells form the outside core of the tubules.

This is excellent; the sort of understanding that can lead to effective treatments...  more, faster, please!

Aperio Awarded Patent for High Performance Viewing of Digital Slides

Please forgive a little horn-blowing, but I have to note this press release with pride: Aperio Awarded Patent for High Performance Viewing of Digital Slides:

Aperio Technologies, Inc., (Aperio), a global leader in digital pathology for the healthcare and life sciences industry, announced today that the United States Patent and Trademark Office has issued the company patent No. 7,738,688 entitled, “System and Method for Viewing Virtual Slides.”

The field of digital pathology is enabled by converting glass microscope slides into digital whole- slide images that can be viewed, managed, and analyzed. A key feature of any digital pathology system is the ability to view digital slides remotely, across local and wide area networks. The ‘688 patent describes novel techniques for processing and displaying digital slide images stored on a server, which facilitate rapid viewing of digital slides. This technology also enables real-time panning and continuous and rapid zooming of very large digital slide images without loss of image fidelity, as well as simultaneous collaborative viewing of digital slides and associated data.

Viewing digital slides across a network is of course a basic capability of digital pathology, at the core of many of the value propositions for the technology, and we've worked long and hard on the underlying software to make our viewing experience as fast and seamless as possible.  It is great to add this patent on our techniques to Aperio's portfolio...

CAP Leaders Stress Need for Oversight of Direct-to-Consumer Tests

In a press release, the College of American Pathologists have Stressed Need for Oversight of Direct-to-Consumer and Laboratory Developed Tests:

With the increasing importance of laboratory tests in diagnosing and treating disease, representatives of the College of American Pathologists (CAP) today presented recommendations to the Food and Drug Administration (FDA) urging increased oversight of laboratory developed tests (LDTs) and "direct-to-consumer" tests. Most genetic tests fall into one or both of these testing categories.

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Since the implementation of the 1976 Medical Device Amendments, the FDA has generally not used its oversight authority to enforce applicable regulations with respect to LDTs.  The FDA convened today's meeting to hear testimony about key issues that it will consider as it develops new regulations that would apply risk-based oversight of LDTs.

Interesting, and this comes in the same timeframe in which the FDA are looking into regulating genetic testing as well.

FDA Wants To Regulate Genetic Testing

Randall Parker's FuturePundit is a great blog, and he recently posted that the FDA Wants To Regulate Genetic Testing:

The FDA wants to get more involved in controlling the genetic testing industry.

In a prelude to overhauling its regulatory oversight of genetic diagnostic testing, the U.S. Food and Drug Administration will convene a public meeting next week to gather input from test makers and others.

The event reflects a turning point in genetic testing, a cornerstone of personalized medicine. Once mainly the domain of rare diseases, scientists have discovered a growing number of genetic variations linked to both the risk of more common disease and patients' response to drugs. The number of genetic diagnostic tests has expanded rapidly, and tests have become increasingly complex, making it more challenging to interpret and act on the results.

Randall notes: "I would prefer the FDA and like regulatory agencies stay out of genetic testing except perhaps to test for error rates and publish the results. The rate of innovation will be faster with less regulatory involvement."

What do you think?  Please post a comment...

The Cell Counting Cryptogram Challenge

Genetic Engineering and Biotech News has posted an interesting challenge on their website; the contest is based on Cell Counting.

Your challenge, should you choose to accept it, is to "decode the cipher hidden in this image".  In case you get stuck, they are going to post weekly clues...  quite interesting, and good luck!

Digital Pathology in Education

When Aperio thinks of the markets for digital pathology, we divide everything into two broad catagories, Healthcare and Life Science.  The market for digital pathology in Education is large and important, and somewhat cuts across these catagories; for pathologists everywhere their entire careers are education, starting with formal schooling but extending onward forever into the future, always more to learn, new techniques, new insights.  And digital pathology certainly helps to share more information more broadly, more efficiently, and more inexpensively.

Consultant Amanda Lowe has posted a nice overview: Digital Pathology in Education, which links a nice CAP presentation by Lewis Hassell and David Frishberg, The Exciting and Expanding Role of Digital Pathology in Pathology Education.  The presentation includes diagrams, audio clips, and a lot of great information, and I definitely encourage you to view it.

Sloan Kettering opens $100M image-guided treatment center

HealthImaging notes Sloan Kettering opens $100M image-guided treatment center:

Memorial Sloan-Kettering Cancer Center in New York City has opened a new $100 million, 40,000-square-foot Center for Image-Guided Intervention (CIGI) for cancer treatments, a new endoscopy suite and expanded its Surgical Day Hospital last month.

CIGI has six procedure rooms offering interventional radiology technology, including fluoroscopy, ultrasound, PET, MRI, CT and two additional angio-CT units.  Approximately 120 patients a day are expected to be seen in the facility, according to the provider.

They don't mention digital pathology but one would expect they will take a lot of core biopsies at this center, and could benefit from remote sufficiency interpretations...

Pathology Groups Prepare to Deliver Results to Smart Phones

The Dark Daily reports Pathology Groups and Clinical Labs Prepare to Deliver Test Results to Smart Phones:

With the advent of data-capable smart phones, disease management is taking a giant step forward. That has important implications for pathologists and clinical laboratory manager, who need to ensure that their medical laboratory information systems are ready for access by smart phones and other wireless devices used by clinicians.

The question I find myself asking is why.  Clearly "everyone" now carries a smartphone, whether iPhone, Android, Blackberry, Palm, or whatever... and the technology to make results avaialble on them now exists.  But what is the use case?  Do oncologists and other clinicians need pathology reports delivered in realtime?  Please comment if you have a view on this...

Pathologists as Clinicians

Bruce Friedman makes a great post on Training Pathologists to be better clinicians.

Although I use the term clinician frequently in this blog, I discovered that I had some difficulty finding a definition for it that satisfied me. I finally hit on the following definition for clinical, which can also be used to define clinician: Pertaining to [the direct] observation and treatment of patients. In the light of this as well as my previous inclinations, I will resist the temptation to classify pathologists and radiologists as clinicians but rather classify them as diagnosticians who act as consultants to clinicians. It is these latter physicians who provide the direct care to patients.

The subject of Pathologists as doctors who treat patients comes up a lot in the hallways at Aperio.  There is a point of view that Pathologists are a sort of lab instrument; you ask them to perform a test, and they deliver the result, and that's it.  We reject this point of view.  There is an essentially subjective and emotional aspect to pathology, there is a human patient, a back story, treatment options, etc. which all must be considered, there is far more than simply using experience and pattern recognition to identify disease upon inspection of specimens.

Viewed from this perspective, digital pathology is a technology which helps pathologists to be doctors who treat patients.  And helping them to do so is most satisfying...

Digital Pathology Adoption Trends by Pathologists

Bruce Friedman is Putting Some Numbers to Digital Pathology Adoption Trends by Pathologists, following a survey article in Laboratory Economics:

Nearly everyone agrees that digital imaging will play a big role in pathology in the future. Academic medical centers, commercial labs and large independent pathology labs are rapidly installing digital pathology systems.  But its use in reimbursable clinical diagnostics is currently limited.  Twenty-two percent of pathology groups and labs currently have a digital imaging system in place, according to LE’s Digital Pathology Trends Survey conducted in June.  Ten-percent plan to add a system within 12 months and another 10% within the next 12-to-24 months.

Today, education and training is the most common use for labs using digital pathology.  The biggest barrier to more clinical use is the cost of scanning digital slides, which don’t eliminate the need to first prepare glass slides.  Among surveyed labs using digital pathology, 72% are using it for education and/or training, according to LE’s Digital Pathology Trends Survey.  Sixty-three percent use it for second opinions and/or consultations, and 62% for quantitative immunohistochemistry for HER2 scoring.  In terms of market share, 44% of digital pathology users have an Aperio system; BioImagene has a 16% share; Ventana, 9%; and Olympus, 8%.  Other vendors have a combined 23% share, including Nikon, Leica Microsystems and Dmetrix.

More than half of surveyed labs without digital pathology cited “too expensive” as a barrier to adoption.  Another 36% said traditional pathology/microscope works fine and 23% had LIS integration concerns.  Only 15% said digital pathology systems were too slow and only 3% had concerns about image resolution.  Meanwhile, Amanda Lowe, principal of Digital Pathology Consultants...believes the limited menu of FDA-cleared tests is a bigger issue than our survey suggests.  “There’s no doubt that if the FDA would ‘gold stamp’ digital pathology on the clinical diagnostic end, it would help significantly,” she says.

Great data.  Naturally we're delighted to see that so many sites adopting digital pathology are using Aperio scanners and software, but equally we are committed to enhancing the value propositions for digital pathology to drive more adoption.  There is a potential network effect underlying adoption of a new technology like this; the more labs adopt it, the more value there is for all labs which have adopted it.

Is the iPad radiology's dream device for mobile healthcare?

On AuntMinne.com, Erik Ridley asks Is the iPad radiology's dream device for mobile healthcare?

The iPad has only been on the market for three months, but it has already generated significant interest and enthusiasm among radiologists and referring physicians. Efforts to define the role of the iPad in radiology are still in their early stages, but a number of researchers and vendors active in developing software applications for the iPad believe it could fulfill a role in bringing access to images and advanced visualization technology to the point of care.

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But don't expect radiologists to ditch their PACS workstations and start interpreting images on iPads any time soon. The iPad would not be suitable for primary diagnosis due to its contrast ratio (maximum luminance/minimum luminance) and calibration issues.

Interesting, of course we at Aperio have been looking at iPads too, trying to figure out if they're useful for viewing digital pathology images.  The panning issues noted in the article are exacerbated by the large image size, and there are also zooming issues in pathology which radiology doesn't have.

As I think about this, there are two considerations.  First, can you use the device - is the image quality sufficient, user interface good enough, etc.  And second, when would you use the device - what is the use case?  I think that the devices probably *are* usable, or if they aren't they will be soon, but I'm fuzzy about whether they're truly useful.  Seems like in every situation where you might use an iPad you could just as well use a laptop.

I'd be most interested in hearing from y'all; please comment if you have a view about whether tablets like the iPad will become important as medical imaging devices.

Veterinary Pathologists Adopting Digital Pathology Faster than MDs

From Steve Potts, CEO of Flagship Biosciences, guest posting on Bruce Friedman's blog: Veterinary Pathologists Adopting Digital Pathology Faster than MDs.

My work with both MD and DVM pathologists has lead me to the following observation: DVM pathologists are "going digital" faster than their MD colleagues. Nearly all of the top 15 pharmaceutical companies have completed multisite-integration with digital pathology. The result of such conversions is that a pathologist working in one location can access slides at any other one or participate in an informal peer review or pathology working group. Veterinary pathologists have proposed GLP [Good Laboratory Practice] standards and agreed on the requirements required of digital pathology vendors in order to meet the FDA compliance guidelines in preclinical testing. The regulations imposed on preclinical toxicology testing prior to first-use in human trials are more strict than clinical trial regulations. Despite this, veterinary pathologists are well prepared for the use of digital slides in these assessments.

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Part of the willingness to adopt digital pathology in pharma companies is economic - the workflow improvements are compelling - but there also seems more willingness to try new technology.

ACR takes on Walter Reed radiologic-pathology course

I've posted a number of times here about the value of combining radiology and pathology information for clinicians (some would say, for "diagnosticians").  In recognition of this, The American College of Radiology (ACR) has launched the American Institute of Radiologic Pathology (AIRP), a four-week course, which will fulfill the requirements previously completed by Walter Reed Army Medical Center's radiologic-pathology correlation course. 

In a series of lectures, case reviews and world-renowned guest speakers, the course is a comprehensive review of radiologic imaging with pathologic correlation. The eight sections of the course include gastrointestinal radiology, genitourinary radiology, musculoskeletal radiology, neuroradiology, pediatric radiology, cardiovascular radiology, breast imaging and thoracic
radiology.

This is interesting, too:

ACR plans to incorporate innovative technology, like an iPad or similar tablet tool, to "enhance" residents' experience.

This seems like the right conclusion:

"The importance of the program is the breadth of the teaching that's delivered there," Freedman says.

Consideration of the Underlying Forces that Promote Pathology Insourcing

Bruce Friedman: Consideration of the Underlying Forces that Promote Pathology Insourcing.

I have come to the conclusion that major drivers are operating to accelerate the trend toward specimen insourcing:

• Diminishing importance of hospitals.
• Complacency and culture of hospital-based pathologists
• Insourcing as a source of new positions for "local" pathologists
• Changes in academic training programs

Whether you think pathology insourcing is good or bad for the field, it seems evident that it is taking place.  Smart pathologists will realizes this and move to adapt to the change.

Sylvia Asa Announced as Pathology Visions Keynote Speaker

SYLVIA ASA, MD, PhD, ANNOUNCED AS KEYNOTE SPEAKER Pathology Visions is pleased to announce Sylvia Asa, MD, PhD, as the 2010 Keynote Speaker. Dr. Asa is the Pathologist-in-Chief and Medical Director of the Laboratory Medicine Program at the University Health Network. As head of the largest pathology department in Canada, Dr. Asa has made innovative changes to the practice of the discipline. To read more about Dr. Asa, click here. PATHOLOGY VISIONS ABSTRACT DEADLINE - ONE WEEK LEFT! The deadline to submit abstracts for oral and poster presentations is June 15! To submit your abstract, click here. Poster presenters will be given a two-day display opportunity. Outstanding posters will be eligible to receive complimentary conference registration. As a presenter, you can share your experiences and discuss potential uses for digital pathology in the future. Submission topics include: Business Case/Reimbursements Cytology Diagnostic Pathology Disease-Specific Drug Development Education Frozen Sections Hematopathology Image Analysis Immunohistochemistry (IHC) Informatics IT Personalized Medicine Research Applications Telepathology Toxicologic Pathology Validating Algorithms To submit your abstract, click here. ABOUT PATHOLOGY VISIONS Pathology Visions is the annual meeting of the Digital Pathology Association, held October 24-27, 2010, at the Sheraton San Diego Hotel and Marina on the beautiful San Diego bay. Enjoy thought-provoking discussions on digital pathology applications and enrich your conference experience through the following: Exciting presentations on new applications Peer-to-peer discussions on digital pathology Hands-on workshops Scientific poster sessions Digital pathology demonstrations Networking events ABOUT THE DIGITAL PATHOLOGY ASSOCIATION (DPA) The mission of the DPA is to facilitate awareness of digital pathology applications in healthcare. Members are encouraged to share best practices and promote the use of the technology among colleagues in order to demonstrate efficiencies, awareness, and its ultimate benefits to patient care. To learn more or apply for membership, visit www.digitalpathologyassociation.org.   For more information, visit www.pathologyvisions.com

The Treatment: the search for cancer drugs

The New Yorker has a wonderful article by Malcolm Gladwell: The Treatment, about the search for cancer drugs.

The article accurately captures some of the challenges, and the difference between working backward from genetic knowledge of cancer to a possible compound that can fight it and just trying a bunch of possible drugs to see which ones could work.  The difficulty of assembling and testing "cocktails" with multiple drugs is also discussed.

And of course Gladwell is a terrific writer; even if his subject wasn't so inherently interesting, his story about it would be!