Driven by the mission to provide better decision–making tools to breast cancer patients and physicians PreludeDxTM was founded in 2009. Over the decade, PreludeDx has emerged as a leader in molecular diagnostics and precision medicine that aims to manage early–stage breast cancer. Leveraging new innovative tools and processes, PreludeDx is rightly poised to thrive for the better management of cancer.
We are delighted to have a conversation with Dan Forche, President and CEO of PreludeDx, to gain better insights into the incredible story of the company.
Decade of Research and Development
In the US, about 56,500 new cases of DCIS will be diagnosed in 2024, according to the American Cancer Society. DCIS or Ductal Carcinoma in Situ is considered an early-stage 0 pre–invasive breast cancer where the cells lining the milk ducts turn malignant but do not spread into surrounding breast tissue (in situ). 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.
To provide the right tool to improve patient outcomes, PreludeDx began their research with funding from the National Cancer Institute. They licensed the initial biomarker technology from the University of California, San Francisco, and extended the discovery work before the company was officially founded in 2009.
For the next several years, PreludeDx continued to develop technology to biologically assess a patient’s risk and radiation therapy benefit. The DCISionRT® test was subsequently developed and extensively validated prior to clinical launch in 2017.
DCISionRT: Unique Traits
The prior standard of care was to use traditional clinicopathological factors, such as age, tumor grade, tumor size and margin status, to make treatment decisions including who to radiate and not. This one size fits all approach resulted in over or under treatment for approximately 40% of patients, based on study results. DCISionRT enables personalized treatment by analyzing a specific patient’s tumor biology and predicting % disease recurrence with surgery alone or surgery plus RT. Personalized test results contribute to making the most informed treatment decision.
The only DCIS Test to predict radiation therapy benefits
DCISionRT is the first and the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that quantifies the risk with 10 years of DCIS recurring or coming back as invasive cancer, as well as predicts how much (if any) radiation therapy might reduce the risk of recurrence.
The DCISionRT test provides a Decision ScoreTM that identifies a woman’s risk as low or elevated on a scale of 1-10. Unlike other risk assessment tools, the DCISionRT test combines proteomic assesment 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.
PreludeDx continues to develop technology to biologically assess patient risk and radiation therapy benefit.
Success Story
Dan Forche, President and CEO speaks about their incredible ongoing success story. “In September of last year, we published data demonstrating that DCISionRT is the first and only test to identify DCIS patients with unexpectedly high residual risk (RRT) after surgery and radiation. Despite receiving both surgery and radiation, these patients remain at a high risk and may need additional therapeutic strategies. In late 2023, we presented data for a novel molecular biosignature to predict RT benefit in early–stage invasive breast cancer at the San Antonio Breast Cancer Symposium, laying the critical groundwork for PreludeDx’s next product.”
Receiving ADLT status was a major milestone for PreludeDx. Dan asserts, “Receiving ADLT status confirmed the clinical value and unique nature of the DCISionRT test. PreludeDx is only the eighth company to receive Advanced Diagnostic Laboratory Test distinction. It is also the only DCIS test validated with peer–reviewed published level 1b evidence and is currently being used by over 1,900 physicians throughout the U.S. and worldwide.”
Thriving Amidst Challenges
Funding is always a challenge for an emerging growth company. But Prelude Dx constantly gained patronage for delivering the highest level of clinical outcomes in early–stage breast cancer. They raised $20 million in March 2022 to advance the commercial market expansion of DCISionRT and continue development of the company’s precision radiomics platform for early–stage breast cancer and other cancers.
“Medicare reimbursement is always a challenge; however, we have made great strides and are moving forward on that front. While early adoption takes time, we have been successful with a large number of top academics throughout the US integrating DCISionRT into their standard work–up for a DCIS patient. Our goal is to empower patients and physicians to make a better, more informed shared decision,” asserts Dan.
Commitment to Wellness Today and Tomorrow
Recognized for its pioneering role in optimizing patient outcomes in breast cancer, PreludeDx is committed to providing early–breast cancer patients and their physicians radiomic tools to make the most informed, personalized treatment decisions regarding radiation therapy. They are actively working to expand their DCIS molecular testing portfolio into early–stage invasive breast cancer, as well as other cancer indications.
Words of Wisdom
Advising aspiring entrepreneurs, Dan Forche shares, “Understand that setbacks 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, again they are a stepping stone to greater success.”
