Blog14_image1.jpgNever has pathology felt more personal than after walking the halls of USCAP, the premier U.S. Anatomic Pathology conference, this past March. The case studies, the patient tissue specimens illuminated on 10 foot backdrops, the innovative company research scientists there in the flesh, the faces of those working so hard to improve patient care…wow. Pathology is getting personal.

The Anatomic Pathology lab has experienced monumental changes in recent years expanding the pathologist’s role beyond a cancer diagnosis to being a key contributor who delivers critical patient results defining treatment selection. The onslaught of genetic and molecular technologies and the increased availability of cancer targeted therapies has further added complexity to the pathologists’ role as they learn new approaches to interpretation of results and reporting. In this era of personalized medicine, it is critical for pathologists to have access to tools supporting their expanded roles.

AMP Blog12a
Since its formation in 1995, the Association for Molecular Pathology (AMP) has been the premier showcase for remarkable technological advancements in the field of molecular diagnostics. The show has seen the evolution of nucleic acid testing from HIV viral load testing in 1996 to a CLIA waived PCR-based strep test in 2015 to the current day explosion of library preparation kits, advances in Next Generation Sequencing, and data management. The show also facilitated key partnerships enabling significant clinical diagnostic product launches.

The 2016 exhibit brought with it a host of exciting new technologies centering around greater sensitivity, actionable information, and rapid results. The desire for better, faster results was clear throughout the exhibit hall, Industry-Sponsored workshops, and scientific sessions through the following recurring themes:


In the world of personalized diagnostics, history does not necessarily predict the future. Following the much anticipated FDA approval of the first immuno-oncology drug Keytruda® (Merck) for NSCLC patients in October 2015 as a Companion Diagnostic (CDx) for PD-L1 testing , all eyes then went to Bristol Myers Squibb with competitor OPDIVO® as the CheckMate 057 trial data emerged for non- squamous NSCLC patient use. Much to the surprise of the oncology community, only two weeks following the Keytruda CDx approval, OPDIVO was approved as a “complementary diagnostic,” a classification unfamiliar in diagnostics not requiring PD-L1 testing for clinical use in nsNSCLC. Really ? What are the implications of a complementary diagnostic test vs a CDx?

Since the development of the first companion diagnostic in 1998, HercepTestTM (Dako North America, an Agilent Company) to select breast cancer patients eligible for Herceptin, the field of personalized diagnostics has evolved significantly. Today with advances in molecular diagnostics, FISH and PCR technologies are commonplace in Companion Diagnostics for HER2 FISH and kRAS/ BRAF respectively. Immunohistochemistry continues to be the mainstay for HER2, EGFR and the new PD-L1 companion diagnostic tests. In the future, we can expect Genome signature assays with techniques such as next generation sequencing (NGS) to become relevant in the personalized diagnostics space.


Who is the ideal target customer for our product?
What features will drive customers to switch to our product?
When will our product be utilized in the patient treatment continuum?
Where do we stand relative to our competitors?
Why do customers resist adoption of our product?
How do we better understand what our customers want?

These are some of the key questions at the forefront of any Marketing, Strategy, or Business Development executive’s mind. While many hours are spent gathered around a conference table trying to answer these questions, oftentimes the most actionable insights come straight from the horse’s mouth - the customers themselves. No one knows better what is needed than the customer. Incorporating Voice of Customer (VOC) insights into your strategy planning provides credible, data-driven support for short- and long-term strategic action plans.

Do social media sites really get your company brand recognition in the diagnostics space? The answer is yes! The top two benefits of social media marketing are increasing exposure and company website traffic. Social Media Examiner1 states that 89% of all marketers revealed their social media efforts generate increased exposure for their business and 75% reporting a positive increase to website traffic.

As a diagnostics marketing professional, you struggle daily to find ways to promote your product or service to drive sales. Where do you begin when creating a social media marketing plan? What is right for your business? How much time do you allocate and what is the return on investment?

As we move through the month of May, Melanoma awareness month, I find myself more keenly aware than ever of the importance of finding a cure.

My story began in April when I received a text from my Dad to "call him when I have the chance" quickly followed by a friend's text to "call ASAP." For those of you in the sandwich generation with aging parents and children you, are always on alert for a middle of the night emergency call. My dad has never been one for drama so I knew immediately with the second message that this was serious. I steeled myself for the call and dialed. Not one to mince words, Dad started the conversation with, "you know how years ago I had that melanoma removed, well it's back."

2015 Grow Your Mind 150On a brisk 30°F morning in March, I slipped into the most comfortable shoes I could find, to tackle a two day USCAP tradeshow tour in Boston, MA. My first impression was -WOW - USCAP is all grown up. I've been attending USCAP since 1999, at a time when the exhibit were in a small hotel ballroom with a handful of vendors like Dako and Novocastra displaying their antibodies and detection systems.


The meeting became more contemporary in the early 2000’s with new entrants in the space like the slick walkaway Ventana Benchmark, at the time when the company was run by Chris Gleeson and Hany Massarany, veterans from the Immunoassay world driving automation within Anatomic Pathology.  Then, about seven years ago, digital pathology entered the scene in a big way and USCAP hit its stride on the path to becoming a premier showcase for advances in pathology.  Venture capitalists helped companies like Aperio and BioImagine to make a huge splash at USCAP beginning in 2010; both companies were acquired by Leica Biosystems and Roche respectively.   At the same time GE (Omnyx),  and Phillips came on the scene.  Phillips driving the breakthrough concept of linking radiology and lab patient information for a pathologist diagnosis on one system.  USCAP would never be the same.  


MarketReadyRx-CDxIn the last decade, tremendous attention has been placed on Personalized Medicine, a new approach using an individual’s genetic makeup to define a more targeted treatment. The value of Companion Diagnostic (CDx) tests as a class of diagnostics driving clinical management of patients is taking hold with CDx tests such as a HER2 helping positive breast cancer patients to gain access to Herceptin. All the noise around personalized medicine, however has only yielded 22 FDA approved CDx tests with a drug, with 10 of these being HER2 tests for Herceptin breast cancer and gastric cancer patient selection.  This means only 12 distinct CDx drug approvals have launched since 1998 when HercepTest®, the first CDx , was launched[1].   Despite the few tests which have passed the rigor of FDA as a Companion Diagnostic, there are more than 85 drugs utilizing pharmacogenomic information in their label[2] today suggesting the importance of biomarkers to drug development and treatment.  Personalized Medicine is hitting its stride and is poised for rapid growth.


Breast-Cancer-Awareness-Clip-Art-7Breast cancer. Two words that can change a life in an instant. Two words which are personal for many of us. Two words driving billions of dollars of research, diagnostic and prognostic test development, and breakthrough treatment options. So, while we have made tremendous strides in advancing the standard of care for breast cancer patients, why are these two words still so chilling and the disease still so lethal?

For a patient who receives a breast cancer diagnosis, the flurry of questions and concerns are all- consuming, sometimes crippling. For this reason, it is critical that marketers of breast cancer diagnostics communicate clearly and confidently to alleviate some of the unknowns. In this blog, we challenge marketers to ask, how can patient messaging improve? How can messaging be clear and less overwhelming? How can a brochure on your breast cancer diagnostic empower a patient as they are a little bit more informed about their disease? These questions are arguably just as important as how to sell the value of your diagnostic test to an Oncologist or Laboratory Director.


Melanoma is not only a seasonal summer cancer.

The statistics are staggering. The American Cancer Society estimates more than 76,000 new melanomas will be diagnosed in the US alone this year. Melanoma rates have been rising for over 30 years with the culprit ranging from a thinning ozone layer to sun loving baby boomers now reaching the average melanoma age of 61.

As with breast cancer, self-exams are an effective method for early intervention described on the National Cancer Institute website. Once a mole or lesion is found to be suspicious, a visit to a dermatologist is warranted for a thorough evaluation. The diagnosis of a suspicious lesion is typically determined by a skin biopsy confirmed by a pathologist evaluation of the skin lesion. Treatment ranges from early stage melanomas, which are simply removed surgically, to a more advanced stage melanoma treatment which may include surgery, chemotherapy, radiation, a biological or targeted therapies.

Follow the patient to most effectively Market your Melanoma:
To understand how to position and market a novel melanoma diagnostic, you first need to understand the patient journey from diagnosis to treatment decisions... 

I don't consider myself a feminist.

In fact, during my 25+ year diagnostics career, I've had the support of both male and female mentors and have been incredibly appreciative of the guidance I have received from both. At the beginning of my career, as a young Quality Manager, I was mentored by an amazing Director of Regulatory Affairs, Elaine Walton. With her encouragement and support, I took chances, despite my fear. Next Ellen Norquist, a National Sales Director, placed her trust in my abilities (despite my lack of experience), propelling me into the world of sales. Later, in my role as a U.S. Director of Marketing, Doug Sweet, Vice President of Marketing, mentored me. These men and women helped to lift me up and encourage me to reach for my goals. However, despite the support and encouragement, I couldn't shake the feeling of insecurity when faced with a new challenge.


I'll be honest. As a prior Marketing Director responsible for a global IVD product portfolio, I struggled everyday to stay on top of all the demands.  Responsible for nine product managers overseeing eight product lines encompassing more than a 1000 products; I spent most of my time representing the marketing needs to management in global meetings, completing daily administrative tasks, and supporting the daily market sales team requests.  There was little time in a day left for strategic thinking or planning even though lifecycle product marketing was a critical part of our role in the organization.   I felt inadequate that we didn't spend the time necessary to explore the long-term strategic health of the business.   Yet we couldn't justify hiring a dedicated strategic marketing expert.