Digital Pathology Blog

Liquid biopsy is defined as, “A test done on a sample of blood to look for cancer cells from a tumor that are circulating in the blood or for pieces of DNA from tumor cells that are in the blood. A liquid biopsy may be used to help find cancer at an early stage. It may also be used to help plan treatment or to find out how well treatment is working or if cancer has come back. Being able to take multiple samples of blood over time may also help doctors understand what kind of molecular changes are taking place in a tumor.”*

Often times the test is regarded as “non-invasive” as it can be performed with simple venipuncture specimens or voided urine samples.

These tests are gaining traction within the industry as a viable alternative to traditional screening methods for cancer. Study results are turning up positive data in favor of the tests, and a recent report by financial services firm Cowen & Co. said annual sales for the tools could surpass $10 billion.

Regardless of your politics or mine, on January 20th a new administration will assume leadership of our country. A few months ago, if you told me I would be hearing “The Cubs won the World Series” and “Donald J. Trump will be our next President,” I would have thought the likelihood of either or both happening would be unlikely. It has been quite seachange of events since November. Although too early to think about the next election process, I am predicting the Cubs to win the World Series in 2017.

During training, I had an attending who actually called the autopsy the "awfultopsy," as in "awfultopsies are not that bad if you only have to do one every other year" – which I think was his personal goal. Sometimes the autopsy pathologist would be out and others would cover if there happened to be a case; so many of my attendings did not have conducting posts as part of their routine practice.

It doesn't even seem like a real number but the year 2017 is close.  High school freshman this year were not born yet on September 11, 2001, which does not seem like that long ago.  15 years have passed since the day when my generation will always recall where they were when they heard/saw what was unfolding – much like my parent’s generation can tell you about Kennedy’s assassination like it was yesterday.

If the dialogue at ASCO this month was any indication, oncologists, who I tremendously respect, actually know about digital pathology.  In many instances their research and/or clinical facilities already use the technology.  Oncologists were familiar with whole slide scanning, image analysis and analytics, and the ability to have cases reviewed quickly without the need to transport glass slides – having seen it successfully used for tumor boards and education in their own institutions. 

On a recent trip, to present at grand rounds at a well-known midwestern medical school, I noticed a dapper gentleman on my flight.  He was wearing a three-piece suit and carrying an impressive attaché case. He stood out among the many travelers dressed in shorts and flip-flops, and who probably wished they hadn’t when we reached our destination where the weather was not as friendly.

A Move by the FDA Signals Possible Classification for Patient Safety and Industry Collaboration

On Jan. 14, 2016, the Digital Pathology Association (DPA) issued a press release suggesting “digital pathology manufacturers currently interested in marketing whole slide imaging (WSI) devices for primary diagnosis in the United States submit de novo applications to the Food and Drug Administration (FDA).”

What exactly does this mean?

The press release goes on to say, “The FDA had previously stated it considered WSI for primary diagnosis to be a Class III medical device. However, FDA had never formally

There is a decades-old theorem first derived at the Mayo Clinic that although based on little actual data has been popularized over the years stating:

• 70% of patients in a hospital have laboratory data.
• 70% of clinical data points (objective information) come from laboratory data.
• 70% of clinical healthcare decisions result from laboratory tests.
• These data account for less than 5-10% of healthcare costs.

This is a lot of bang for the buck. Imagine 70% of objective information assisting in 70% of healthcare decisions for as little as 5% of total healthcare expenditures.

Almost 3 years ago I wrote a piece for Advance for Administrators of the Laboratory in their "Perspectives in Pathology" entitled Death of the General (Surgical) Pathologist.

This piece discussed the issues surrounding what is perceived by many as the increasing (and necessary) sub-specialization in pathology.  The model of "everybody doing everything” has evolved into “everybody doing one thing".

Historically, practicing pathologists were solid general surgical pathologists, often times with their own expertise/interest in a particular area, but they prided themselves on being "surgical pathologists" rather than "liver", "hemato-" or "dermato-" pathologists as in today’s world. A number of factors have driven and resulted in this trend.  

First and foremost, the needs of the market.  Dedicated specialists in breast or gastrointestinal diseases are commonplace in medicine including the radiologist, surgeon, oncologist and radiation therapist.  Pathology appropriately responded accordingly. Secondly, pathologists have driven some our own marketing and needs.  The resulting potential problems are paramount and based on many fallacies.

Dr. Keith Kaplan, Chief Medical Officer for Corista, LLC, offers his thoughts on “The State of Pathology Today” and some strategies for facing today’s challenges. 

Today, the state of pathology, along with our national leadership and organizations, seems fragmented and without direction. I attended the College of American Pathologists (CAP) and House of Delegates meetings earlier this month, and there seem to be a few issues which we cannot deal with as a group:

• Needs of academics vs. community-based hospitals: From the need for AP/CP generalists in some settings to the need for sub-specialists in others, how do we best practice our specialty? We seem to be an increasingly heterogeneous group with loss of identity.