Enhancing Utility Data of Prognostic Assay for Skin Cancer

Product Development Case Study

Background

While cutaneous squamous cell carcinoma (SCC) is treatable if caught early, it can be aggressive and even deadly if it metastasizes.  SCC is the 2nd most common form of skin cancer, following basal cell carcinoma. This test identifies the risk of metastasis in SCC patients through a deep neural network that analyzes 44 genes of the cancerous tissue.

The most common personas include Dermatologists, Mohs Surgeons, and NPs/PAs. Each of these personas have different end goals and motivations, summarized as follows:

  • Dermatologists: Healthcare professional who is most often involved in the identification and diagnosis of squamous cell skin cancer. Often, they are responsible for referring patients to other specialties, if needed.

  • NPs / PAs: As the Dermatology market continues to consolidate, many patients often see a Dermatology NP/PA for visits. NPs / PAs are often tasked with ordering additional testing and may be tasked with assisting Dermatologists in determining / recommendation of next steps for patient care.  

  • Mohs Surgeons: Mohs is a type of surgery performed to remove skin cancer cells by removing layers of the skin and analyzing the tissue under a microscope as layers are removed until the margins are clear of any cancerous cells. A specific certification is needed to perform Mohs surgery, and it is the most common treatment for SCC.

At this time there are no direct competitors to this test, although there are other labs currently performing research to develop.

Problem Identification:

The Sales team first signaled to us a consistent level of requests coming from customers around utilization data of the assay and a lack of evidence on who should order the test and when is the best time to order. Through in-person advisory boards, we collected feedback from speakers that examples of their real-life patients were highly resonating with audiences.

Objective:

Provide strong evidence for utility of the test.

Opportunity:

At the time, we did not offer any real-world examples of utilization of the test. This forces customers to travel to a conference and attend an advisory board to learn more about real patient success stories.

Hypotheses:

  • Publishing new data will not only strengthen customers’ perspectives and beliefs in the test, but also enable Sales to better perform their responsibilities and fulfill their goals. The publication of new data is required in order to continue engaging existing customers to place additional orders, which can lead to capturing new customers as well.

  • Creating new real-world patient case materials will provide value for customers today. This allows prospective customers to learn more about the utility of the test from their offices and / or homes, rather than requiring travel which takes away from time with their patients.

I want to… see real-world patient cases in which the test was utilized

So that I can… identify similarities in my own cases (e.g. risk factors) that help determine when to order the test moving forward.

Example: Order the test on all patient cases that have perineural invasion AND the tumor size is >2cm.

I want to… see an algorithm (or workflow) based on real-word clinicians that helps me identify when to order the test, and what I can do with the test results.

So that I can… easily reference the algorithm with my own real-world patients, especially when it comes to “difficult” cases.

Example: Clinician has a “gut” feeling when an SCC is high-risk, but the risk factors are not considered “high-risk” according to the most used SCC guidelines (AJCC 8, BWH, NCCN). Algorithm can assist in determining when it might be appropriate to order the test.

Outcome:

Data collection was tasked to / led by R&D in partnership with a dermatologist and two Mohs surgeons / Dermatologists. The team drafted a manuscript and submitted for publication. The manuscript was successfully published as a medical research paper in a respected journal. I redesigned the basic algorithm to be leveraged by Dermatologists, Mohs Surgeons, and NPs/PAs, which was published as well.

Fast-Follow Enhancements:

On top of addressing the gap in utilization data, we were able to create commercially friendly print materials and digital content showcasing the data.

  • PRINT REAL-WORLD PATIENT CASE STUDIES: I created multiple real-world patient case studies for print and drop shipped 25 copies of each case to the field team for distribution.

  • EMAIL CAMPAIGN AND LANDING PAGES: I launched a 4-part email campaign with landing pages of digital versions of the case studies and achieved an open rate of >50% for each part of the series.

  • EVENTS CONTENT: With the design team we developed versions of the case studies to display at conferences and events for potential customers to interact with and click-through.