TEST:

DCISionRT

In our study, radiologic distribution did not correlate with DCISionRT risk subtypes. A larger tumor size, more advanced histologic grade, and advanced patient age correlated with DCISionRT subtypes of an elevated or residual risk. This study uses a genomic risk assessment tool as a surrogate for identifying lesions with a high recurrence risk.

"Prelude Corporation (PreludeDx™)...presented data on the use of DCISionRT® to identify a subset of patients with high-risk clinicopathology who had a low 10-year risk of in-breast recurrence (IBR) and no significant benefit from radiation therapy (RT). In contrast, patients who had both high risk DCISionRT and high-risk clinicopathology had high 10-year IBR rates and significant RT benefit. The data was presented at the 25th American Society of Breast Surgeons (ASBrS) Annual Meeting, held on April 10 – 14, 2024 at the Orlando World Center Marriott."

"Prelude Corporation...announced that data will be highlighted in a Quickshot Scientific Session and poster presentation at the 25th American Society of Breast Surgeons (ASBrS) Annual Meeting, to be held on April 10 - 14, 2024 at the Orlando World Center Marriott."

No abstracts available

"Prelude Corporation...today announced that data will be highlighted in three separate poster presentations at the 2024 Miami Breast Cancer Conference (MBCC), held on March 7 – 10, 2024 at the Fontainebleau, Miami Beach, FL....'We are excited to share data regarding our novel biosignature for invasive Stage I, II breast cancer test for radiation therapy, as well as clinical utility data on our DCISionRT test for DCIS at the prestigious MBCC conference.'"

P=NA | N= 483 | "Prelude Corporation...announced it will present data demonstrating the decision impact on physician recommendations for radiation therapy (RT) in ductal carcinoma in situ (DCIS) patients in Australia. The data will be presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), held on December 5 - 9, 2023 at the Henry B. Gonzalez Convention Center, San Antonio, Texas. The poster...demonstrates that the use of DCISionRT resulted in significant changes in recommendations to add or omit RT compared to clinicopathologic factors (CP) alone. Specifically, in the interim analysis of 483-patients treated with breast conserving surgery in Australia, the use of the test resulted in a 41% change in RT recommendations and a 9% change in hormone therapy (HT) recommendations."

"Prelude Corporation...today announced that data will be presented in two separate poster presentations at the 2023 San Antonio Breast Cancer Symposium (SABCS), held on December 5 - 9, 2023 at the Henry B. Gonzalez Convention Center, San Antonio, Texas....'We are pleased to present additional data on the development of our invasive Stage 1/2 breast cancer test for radiation therapy, as well as expanded international data from our PREDICT Australia study at the prestigious SABCS.'"

It seems reasonable to omit RT in pre-specified low-risk groups with minimal effect on recurrence risk. Costs per prevented recurrence varied more than two-fold but which strategy that could be considered most cost-effective needs to be further evaluated, including the DCISionRT-test price.

This analysis demonstrates that the use of the 7-gene predictive biosignature resulted in significant changes in recommendations to add or omit RT in this study of 483 women. The integration of DCISionRT into the clinical decision-making processes has a substantial impact on recommendations to personalize care and prevent over- or under-treatment. Table 1: Impact of DCISionRT on Adjuvant Radiation Recommendations by Clinicopathologic Features

This analysis of over 2,000 patients demonstrates significant changes in recommendations to add or omit RT based on the 7-gene predictive. The integration of DCISionRT into clinical decision processes has substantial impact on recommendations aimed at optimal management to prevent over- or under-treatment.

P=NA| N=926 | "Prelude Corporation...announced study results of 926 women demonstrating that DCISionRT^®, the 7-gene biosignature for patients with ductal carcinoma in situ (DCIS), reclassified Clinical Pathologic (CP) Low-Risk patients defined by RTOG-9804 and MSKCC-like DCIS models as DCISionRT High-Risk....The oral presentation...demonstrated that patients reclassified into the DCISionRT Low-Risk group had a 10-yr IBR risk of 5.6% after breast conserving surgery (BCS) and no significant RT benefit (0.8% absolute RT benefit, p-0.70), demonstrating a 99% negative predictive value (NPV) for RT benefit. Conversely, the study also demonstrated patients reclassified into the DCISionRT High-Risk groups had higher IBR rates without RT (20% and 12%) and significant absolute IBR rate reductions (13% and 8%) from RT."

"Prelude Corporation...announced it will be presenting data using DCISionRT to identify limitations in current clinicopathologic factors alone to predict radiation benefit in women with ductal carcinoma in situ (DCIS). This comparison data was selected for a scientific session oral presentation at the 65th Annual American Society for Radiation Oncology (ASTRO) Meeting, to be held on October 1-4, 2023 at the San Diego Convention Center, San Diego, CA."

This analysis of over 2,000 patients demonstrates significant changes in recommendations to add or omit RT based on the 7-gene predictive. The integration of DCISionRT into clinical decision processes has substantial impact on recommendations aimed at optimal management to prevent over- or under-treatment.

To prove clinical utility, these biomarkers require careful predictive modeling with calibration and external validation, and evidence of benefit to patients; on this front, further research is needed. Most trials do not incorporate molecular biomarkers in evaluating de-escalation of therapy for DCIS; however, one-the Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk DCIS (ELISA) trial-incorporates the Oncotype DX DCIS score in defining a low-risk population and is an important next step in this line of research.

The analytical performance of the PreludeDx DCISionRT molecular assays was high in representative formalin-fixed, paraffin-embedded breast tumor specimens. The DCISionRT test has been analytically validated and has been clinically validated in multiple peer-reviewed published studies.

"Prelude Corporation...announced that a paper...was published in Frontiers in Oncology. The paper presents the results from analytical validation and summarizes the clinical validation for the DCISionRT^® test. The analytical validation demonstrated that the DCISionRT assay has high sensitivity, specificity, and accuracy/reproducibility of ≥95%. These findings validate the continued increase in clinical adoption of the DCISionRT test to guide shared decision making for patients with ductal carcinoma in situ (DCIS), often referred to as Stage 0 breast cancer."

P=Obs | N=2,500 | "Prelude Corporation...announced new results evaluating the decision impact for radiation therapy (RT) recommendations incorporating the DCISionRT test by race (White vs. Black) in women with ductal carcinoma in situ (DCIS) enrolled in the PREDICT study. The data was presented at the 24th Annual Meeting of the American Society of Breast Surgeons (ASBrS), held on April 26 - 30, 2023 at the John B. Hynes Veterans Memorial Convention Center in Boston, Massachusetts....RT recommendations were changed significantly in both 39% of White and 37% of Black patients. However, Black patients had a 10% higher rate of RT recommendation when compared with White patients with similar biosignature results."

"Prelude Corporation...announced it will be presenting data using DCISionRT to examine the decision impact on physician recommendation for adjuvant radiation therapy by race (White vs. Black) in women with ductal carcinoma in situ (DCIS) enrolled in the PREDICT study. This race/ethnicity data will be presented at the 24th Annual Meeting of the American Society of Breast Surgeons (ASBrS), being held on April 26 – 30, 2023 at the John B. Hynes Veterans Memorial Convention Center in Boston, Massachusetts."

"Prelude Corporation (PreludeDx™)...announced that the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status effective April 1, 2023, for the DCISionRT^® test."

The risk prediction of molecular signatures is independent of other risk stratification tools developed in DCIS, and have a tendency toward RT de-escalation. Further studies are needed to assess the impact on mortality.

"Prelude Corporation...announced it has entered into a managed care provider agreement with MediNcrease Health Plans, a national provider network in the US, to make accessible the PreludeDx’s DCISionRT test to its clients and payers. Under the agreement, MediNcrease’s clients and payers, providers, and their patients throughout the U.S. will now have access to DCISionRT, the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy (RT) benefit."

"Prelude Corporation...announced it will be presenting data comparing risk stratification and radiation benefit (RT) for patients with ductal carcinoma in situ (DCIS) using DCISionRT™ with a clinicopathologic (CP) model similar to the Memorial Sloan Kettering Cancer Center (MSKCC) DCIS nomogram at the 40th Annual Miami Breast Cancer Conference (MBCC), being held on March 2 – 5, 2023 at the Fontainebleau Miami Beach....The study included 926 DCIS patients from four cohorts who were treated with breast conserving surgery (BCS) or BCS + radiation therapy (RT). The study compared MSKCC DCIS nomogram-like model with the DCISionRT 7-gene biosignature."

"Prelude Corporation...announced it has entered into a managed care provider agreement with Medical Cost Containment Professionals LLC (MCCP) to process out-of-network claims for PreludeDx’s DCISionRT test. Under the agreement, MCCP’s more than 150,000 providers nationwide and their patients throughout the U.S. will now have access to DCISionRT, the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy (RT) benefit."

P=NA | N=926 | "Prelude Corporation...announced study results demonstrating that DCISionRT provides patients with ductal carcinoma in situ (DCIS) superior recurrence risk stratification and radiation therapy (RT) benefit prediction compared to commonly used clinicopathologic (CP) features...This study....revealed in 926 women from four cohorts, that DCISionRT was a superior predictor of 10-year IBR rates and RT benefit compared to clinicopathologic criteria. DCISionRT identified that approximately half of CP-Low Risk patients were classified as elevated risk by the test and significantly benefited from RT with an absolute 17.7% reduction in 10-year ipsilateral breast recurrence. Whereas DCISionRT Low Risk patients, which included about one-third of CP High-Risk patients, had no significant RT benefit, representing a true low risk group."

"Prelude Corporation...announced today that data will be presented in four separate poster presentations at the 2022 San Antonio Breast Cancer Symposium (SABCS), to be held on December 6 – 10, 2022 at the Henry B. Gonzalez Convention Center in San Antonio, TX. Presentations will include a spotlight poster on DCISionRT and its identification of a low-risk group of DCIS patients with no benefit from adjuvant radiation, a poster addressing the role of DCISionRT in treatment implications for HER2(+) patients, and two separate presentations on the latest data in the Predict Registry studies from both the U.S. and Australia."

"GenesisCare...announced interim results from the AUSPREDICT registry. Data presented at the Australasian International Breast Congress demonstrates a significant (45%) change in radiation therapy treatment recommendations1 when using the DCISionRT test, optimising management to prevent over and under treatment of Australian women with Ductal Carcinoma In Situ (DCIS)."

Present and Planned Accrual: We are planning to enroll up to 1,500 women from up to 100 sites across Australia. A similar registry has recently completed enrollment of 2,500 women from 68 sites in the US.

"Prelude Corporation...announced study results demonstrating that DCISionRT provides patients with ductal carcinoma in situ (DCIS) superior risk and RT benefit prediction compared to common clinicopathologic features....This study...highlighted that clinicopathologic criteria were poor predictors of 10-year ipsilateral breast recurrence (IBR) rates and radiation therapy (RT) benefit in 926 women from four international cohorts."

"Prelude Corporation..announced today that its prospective data of 926 patients demonstrating the clinical utility of DCISionRT and its Residual Risk Subtype (RRt) was selected for a scientific session oral presentation at the 64th Annual American Society for Radiation Oncology (ASTRO) Meeting, to be held on October 23 – 26, 2022 at the Henry B. Gonzalez Convention Center in San Antonio, TX."

This analysis demonstrates significant changes in recommendations to add or omit RT based on the 7-gene predictive biosignature in 2,308 patients. The integration of DCISionRT into clinical decision processes has substantial impact on recommendations aimed at optimal management to prevent over- or under-treatment.

The DCISionRT Residual Risk group was predictive for 10-year IBR risk after BCS plus RT in women with HER2(+) DCIS. Approximately 40% of patients with HER2(+) DCIS would be expected to achieve low rates of recurrence with BCS and RT, while about 60% of these women (classified in the Residual Risk group) would have higher recurrence rates and may benefit from further therapy, such as HER2-directed therapies. These findings suggest that if the results of the B43 trial were re-analyzed using the predictive 7-gene biosignature (DCISionRT with Residual Risk Subtype), better clarity could be gained on the true impact of trastuzumab on IBR rates in patients with HER2(+) DCIS and the patients most likely to benefit from this additional therapy.

In a large multicenter population, DCISionRT was a better predictor of 10-yr prognosis and RT benefit than CP criteria alone. Pts with biosignature Low Risk disease, comprising about 1/3 of CP high-risk pts, had no significant RT benefit. Whereas pts with biosignature High Risk disease, comprising about 1/2 of CP low-risk pts, significantly benefited from RT, highlighting the lack of accuracy of these CP factors in assessing RT benefit.

P=NA | N=926 | "Prelude Corporation...announced the publication of clinical study data in the International Journal of Radiation Oncology· Biology· Physics ('Red Journal'). The study demonstrated that the DCISionRT^® Residual Risk Subtype (RRt) identified ductal carcinoma in situ (DCIS) patients who had a much higher recurrence risk following breast conserving surgery (BCS) and radiation therapy (RT)....This study...evaluated 10-year recurrence risk in 926 women diagnosed with DCIS and treated with BCS with or without RT. Patients in the RRt group had a 42% risk of recurrence after BCS and a significantly elevated recurrence rate of 14.7% after BCS and RT."

"Prelude Corporation...announced compelling results in 926 women diagnosed with ductal carcinoma in situ (DCIS) identifying patients with low risk of recurrence independent of traditional clinicopathologic risk factors. Study results were presented today at the American Association for Cancer Research (AACR) Special Conference: Rethinking DCIS: An Opportunity for Prevention...The DCISionRT® test demonstrated that radiation did not significantly reduce the in-breast recurrence (IBR) rate in the low-risk group. However, the elevated/residual-risk group benefited significantly from radiation therapy (RT), with a 17.7% absolute 10-year IBR rate reduction."

"Prelude Corporation (PreludeDx)...announced...that it has signed an agreement with Galaxy Health Network to provide coverage for the company’s novel DCISionRT test for ductal carcinoma in situ (DCIS), also known as stage zero breast cancer. Under the agreement, Galaxy’s more than 3.5 million members and over 400,000 providers will now have access to DCISionRT."

Tamoxifen and aromatase inhibitors have been proven to reduce the risk of recurrence by about 30-50%, and their use should be expected to decrease risk of recurrence...And for those with clear margins, there was excellent (100%) agreement between the Nomogram and the refined Oncotype DCIS score. Given the need for cost-based value in health care, and given the cost-free availability of a validated predictive online DCIS nomogram, rigorous evaluation of predictive accuracy and proof of significant added clinical benefit should be performed and made available before any new expensive commercially available test is adopted for clinical use.

"Prelude Corporation...announced today that it has signed an agreement with Three Rivers Provider Network, Inc. (TRPN)...Under the agreement, TRPN's more than 200 million members will now have access to DCISionRT."

This article reviews the current status and existing published literature on DCIS molecular-risk assessment tools and their potential for guiding postoperative RT recommendations in the BCT setting. In addition, current trials studying omission of definitive surgery for low-risk DCIS are discussed.

"Prelude Corporation...announced compelling results in 926 women diagnosed with ductal carcinoma in situ (DCIS). The new information was presented in an oral abstract session at the American Society of Clinical Oncology (ASCO) Annual Meeting at McCormick Place, Chicago, IL...The results of the study demonstrated that after breast conserving surgery (BCS) patients in the DCISionRT elevated risk group had a significant risk reduction from endocrine therapy (ET), while those patients in the DS low risk group did not have a significant risk reduction from ET."

"Prelude Corporation...announced today that its study in 926 DCIS patients demonstrating the clinical utility of DCISionRT was selected for an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. The results evaluating the association of DCISionRT, a predictive DCIS Biosignature to assess the impact of Endocrine Therapy (ET) on 10-year ipsilateral breast recurrence (IBR) risk after breast conserving surgery alone or with radiation therapy (RT), will be presented on June 7, 2022 at McCormick Place, Chicago, IL."

Status On January 4, 2022, the study met its phase 1 accrual goal of 2500 patients from 67 institutions. Additional research objectives are being planned, and accrual is scheduled to reopen around midyear 2022.

The DCISionRT biosignature score along with clinical and pathological features resulted in a 30% reduction in adjuvant radiation therapy in this single-institution cohort. The only other factor predictive of receipt of radiation was tumor size. Long-term follow-up of outcomes and continued multidisciplinary incorporation of the biosignature is likely to identify increasing numbers of patients with DCIS who can safely forego radiation following breast-conserving surgery.