The Silicon Review
Ductal carcinoma in situ (DCIS) is the presence of abnormal cells inside a milk duct in the breast. It is considered the earliest form of breast cancer. In the U.S., over 48,000 women are newly diagnosed with DCIS each year.
The current standard of care for a DCIS patient is to undergo breast-conserving surgery followed by radiation therapy (RT). However, many women are reluctant to immediately pursue RT due to the potential adverse side effects and the fact that it precludes radiation therapy in the future. PreludeDx™ developed DCISionRT® with the vision of creating a DCIS test that not only offered women an individualized risk of recurrence but could also predict her individualized radiation therapy benefit.
DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that quantifies the risk of DCIS recurring and predicts how much (if any) radiation therapy might reduce the risk of recurrence. DCISionRT combines the latest innovations in molecular biology with artificial intelligence and machine learning to deliver the most highly validated DCIS test available.
In the recent landmark randomized SweDCIS publication, DCISionRT assessed 10-yr outcomes in 504 women treated with breast conserving surgery (BCS) and randomized into RT or no RT arms. Patients in the DCISionRT elevated risk group had a 9% significant reduction in invasive risk from radiation therapy. While women in the low risk group had a 1% non-significant difference after receiving radiation therapy. The results are highly consistent with three prior DCISionRT studies, further validating the predictive value of the assay and enabling truly personalized treatment. With DCISionRT, women and their physicians can now have greater peace of mind when making a personalized decision to add or omit radiation therapy after breast-conserving surgery.
We interviewed Dan Forche, President and CEO of PreludeDx, to know more about his leadership which has been pivotal in giving the company direction and great success since he took on the reins of PreludeDx in 2016. Read on for the excerpts from the interview.
Q. What are the notable functions of DCISionRT?
The DCISionRT test is currently being used by over 1,100 physicians throughout the U.S. and worldwide. The test provides a Decision ScoreTM that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information.
DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.
Q. How does your solution align with the existing medical practice?
Presently standard of care for DCIS is to radiate most patients after breast conserving surgery. This one-size-fits-all approach occurs because doctors did not have a test like DCISionRT to accurately assess risk and radiation benefit. The only tools available for use were clinical and pathological (clinpath) features, such as tumor grade, tumor size and margin status, which are inadequate to assess a patients recurrence risk.
Highest level of clinical evidence from landmark clinical trials repeatedly demonstrate clinpath fails to identify patients who can safely omit RT. DCISionRT analyzes a specific patient’s tumor biology and predicts the percentage of disease recurrence with surgery alone or surgery plus RT. Quantitative, personalized test results that contribute to making the most informed treatment decision – this is the “million-dollar question” patients and their doctors need to have answered.
Q. What would you say are the top three skills needed to be a successful CEO?
You need to be persistently positive as you are setting the foundation of success for the team. There will be many issues, conflicts and challenges, but you must always have a positive outlook that ‘we will overcome all obstacles.’ You set the tone.
You have to be good if not great in all key areas of sales and marketing, finance and accounting practices, operations/manufacturing, and quality control.
Further, you have to have a clear vision of what you want your company to be now and in the future and passion is key. Your passion will help drive the company/employees to execute the vision. The other thing I would add since we are in the cancer diagnostics space is that you have to be highly passionate about helping patients and doing your best to help them each and every day you come to work. We realize that every patient sample that comes to our lab has a patient behind it. That patient is nervous, worried and dealing with a tough situation. The good thing is that we can help the patient make a better, more informed decision with their treatment. That gets you out of bed each day to know you are a part of helping patients in a difficult situation.
Also, you need to be a great evaluator of talent. This is key to any company as you never will succeed alone and it takes EVERYONE doing their part each day to achieve success. So, talent is vitally important as your company is your people. You need to hire the best and brightest.
Q. If you had one piece of advice for someone just starting out, what would it be?
Understand that set backs are not a bad thing for a company as they are just part of the process and the journey to achieve greater goals and greater success. There is always a little pain before the gain. Embrace the challenges each day – they are the stepping stones to success.
Q. Do you have any new services ready to be launched?
We are committed to providing early-breast cancer patients and their physicians radiogenomic tools to make the most informed, personalized treatment decisions regarding radiation therapy. Next up to be launched will be DCISionRT+ and its Residual Risk Subtype (RRt). It will identify patients who will have a high risk of recurrence in spite of receiving both surgery and radiation. These are the patients who may need additional therapeutic strategies.
Q. What does the future hold for PreludeDx and its customers?
We are working towards fulfilling our promise to early-breast cancer patients and their physicians; we plan to provide testing tools around the disease types of Invasive (Stage 1 and 2) breast cancer, as well as Atypical ductal hyperplasia (ADH).
About the Leader
Dan Forche, President and CEO
Dan has over 25 years of operational and commercial diagnostic experience at large and startup companies. His previous executive roles have included President of Pathnostics, a full-service cancer diagnostics company, General Manager of Abbott Laboratories’ oncology lab company; VP of Sales and Marketing for CombiMatrix Corporation; and Senior VP of Sales and Marketing of Netherlands-based Agendia, makers of MammaPrint, the first FDA-cleared IVDMIA test for breast cancer recurrence. Dan joined Prelude in 2016 prior to the company ramping up commercial operations.