PreludeDx developed DCISionRT based on technology licensed from the University of California San Francisco and research that began with support from the National Cancer Institute.
Dan’s Journey
Dan Forche, President and CEO of PreludeDx, had early exposure to healthcare that sparked a desire to enter the field and make a positive impact. When Dan was 15 years old, his older brother had a diving accident and became a quadriplegic. He witnessed firsthand the challenges his brother faced and the opportunities to improve the patient experience within the healthcare system.
Dan says, “The fact that so many of my relatives have dealt with various cancers including breast cancer throughout the years motivated me to work in healthcare. Early in my work with Abbott, I was first exposed to oncology while selling several tests for specialized markers like PSA, CEA, CA-125, and CA 15-3. When HER2/neu testing became the required test for Herceptin therapy for invasive breast cancer, that’s when I started to pay attention to targeted therapies and companion diagnostics. I am committed to the continual advancement of personalized medicine and precision testing to improve treatment decision-making and patient outcomes for physicians and their patients.”
An Introduction To DCISionRT And The Unmet Medical Need
Ductal carcinoma in situ (DCIS), also known as stage zero breast cancer, is characterized by the presence of abnormal cells inside a milk duct in the breast. According to the American Cancer Society, about 55,720 new cases of DCIS are diagnosed each year. After DCIS diagnosis, a patient’s treatment decision is traditionally based on clinicopathologic factors including tumor size, grade, and margin, as well as the patient’s age. Breast-conserving surgery (BCS) followed by radiation therapy (RT) is the standard treatment for DCIS. However, the majority of patients do not have disease recurrence after BCS alone, and many women fear receiving overtreatment with RT due to potential adverse side effects. The challenge lies in identifying the patient’s risk of recurrence and benefit from radiation therapy, as every patient is different.
Unlike other risk assessment tools, the DCISionRT test provides patients with a personalized risk of recurrence after breast-conserving surgery and also predicts radiation therapy benefits to help patients and their doctors make the most informed and customized decision. DCISionRT combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors to better interpret complex biological information, providing the patient and physician with actionable, personalized information.
DCISionRT test results give patients:
- Their personal Decision Score (scale of 0-10)
- Their risk of recurrence over 10 years with surgery alone
- The benefit of radiation therapy: Their risk of recurrence over 10 years with surgery plus radiation therapy
The DCISionRT test has been provided to over 17,000 women and has been ordered by over 1,700 clinicians globally. A recent Annals of Surgical Oncology study indicated that DCISionRT modified physicians’ treatment recommendation for RT in 42% of DCIS patients. This new information helps doctors and patients more confidently choose a personalized treatment path and avoid potentially under or over-treatment.
Positioning DCISionRT in The Current Clinical Landscape
In prior major clinical studies, pathological and clinical factors, including tumor grade, size, and margin status, failed to identify patients who could safely omit RT after BCS. DCISionRT predicts disease recurrence after surgery or surgery with RT based on a patient’s tumor biology. Quantitative and personalized test results help facilitate individualized treatment decisions. Precision medicine will help answer the “million-dollar question” – who can safely omit radiation therapy after breast-conserving surgery?
Precision medicine is booming. One projection by Strategic Market Research LLP is $66.22 billion in 2021 to $175.6 billion in 2030. In 2020, roughly 40% of market revenue came from oncology.
Advancement In The Industry
Our cutting-edge precision medicine test, DCISionRT integrates the most recent developments in molecular biology with artificial intelligence and machine learning. It is the only risk assessment test for individuals with DCIS that considers the patient’s biology to estimate the probability of DCIS returning and forecast how much (if any) radiation therapy (RT) would lower the chance of recurrence.
In addition, DCISionRT is the DCIS test with a high level of published supportive evidence and the only test verified by peer-reviewed published Level 1b evidence data.
DCISionRT Service Explanation
A tissue sample taken after breast-conserving surgery or from a core biopsy is used for the DCISionRT test. The pathology report, medical notes, and a completed test-order-requisition form are all sent to the PreludeDx lab by the physician. The PreludeDx customer care representative will then request the tissue sample from the pathology laboratory, making the process convenient for the doctor and patients. After receipt of the tissue specimen at the PreludeDx laboratory, DCISionRT results are typically available within 3-5 days.
Helping Clients Overcome The Challenges
It has been known that DCIS patients were diverse and needed personalized treatment, but until DCISionRT, there was no method to identify who would and would not benefit from RT after BCS, and who would still have an elevated risk of disease recurrence even after BCS and RT.
Physicians want to minimize under or over-treating DCIS patients, but before DCISionRT, confidently identifying the proper treatment decision for each patient was very difficult. Additionally, DCISionRT test results help facilitate collaboration between interdisciplinary medical care teams. Clinicians who use DCISionRT often say they can’t imagine practicing without it, as it plays a critical role in shared decision-making with their patients.
Exciting Things On The Way
DCISionRT gives early-breast cancer patients and their doctors radiogenic tools to make the best therapy decisions. Recently, PreludeDx published new data demonstrating that DCISionRT can identify patients with a Residual Risk Subtype (RRt). Patients with this RRt phenotype have a high risk of recurrence even after the standard therapy of surgery and radiation. These patients may need closer follow-up and/or further treatment per their doctors’ high-risk protocol.
For the future, the company is developing a portfolio of precision medicine tests for invasive breast cancer and other cancer types.
Conclusion
PreludeDx developed DCISionRT, a DCIS-specific test that provides actionable information to patients and their physicians. DCISionRT is the only test that is both prognostic for 10-year risk of recurrence and predictive for assessing radiation therapy benefit. The test helps DCIS patients and their care team of surgeons, radiation oncologists, nurses, and more, make a personalized and better-shared decision regarding treatment which improves patient outcomes and quality of life.
