COMPANY:

PreludeDx

P=NA | N=NA | "Prelude Corporation...announced results of a cutting-edge study in Clinical Breast Cancer....The study evaluated HER2-positive patients treated with breast conserving surgery (BCS) plus radiation therapy (RT) to determine if the DCISionRT test could identify those patients with elevated residual risk remaining after treatment. The study showed that patients with the DCISionRT Residual Risk subtype had significantly higher in-breast recurrence (IBR) rates compared to those without the Residual Risk subtype (16.2% vs 1.6%, p=.01)....DCISionRT successfully identified two distinct groups of HER2(3+) DCIS patients treated with breast-conserving surgery (BCS) plus radiation therapy (RT) that could not be identified using traditional clinicopathologic factors."

"Prelude Corporation...and Cancer Help Desk, have partnered to provide expert nurse navigation services for women diagnosed with ductal carcinoma in situ (DCIS) breast cancer. This alliance allows for direct engagement between newly diagnosed DCIS patients seeking assistance with clinical options and healthcare professionals trained in breast cancer patient navigation....This novel collaboration within the diagnostic laboratory testing space demonstrates a shared commitment to empowering patients with tools needed to inform their treatment decision-making and planning processes."

"Prelude Corporation...announced an important advancement in the field of breast cancer care with the publication of the PREDICT study in the Annals of Surgical Oncology (ASO)....Significant impact on treatment decisions: DCISionRT test results led to a change in pre-test to post-test RT recommendations for 38% of women, highlighting its clinical utility in optimizing treatment plans based on individual patient risk profiles. Net reduction in RT recommendations: Overall, the test contributed to a 20% net reduction in the number of women recommended for RT, potentially sparing many from unnecessary treatment and associated side effects."

"Prelude Corporation...announced that it will share data demonstrating the power of its DCISionRT test to better predict radiation therapy (RT) benefit in comparison to clinicopathologic risk factors for women with ductal carcinoma in situ (DCIS) at The American Society of Clinical Oncology (ASCO), to be held on May 31 – June 4, 2024 at the McCormick Place in Chicago....Of particular importance, the DCISionRT biosignature identified a low-risk group of patients with no significant benefit from ET or RT after breast-conserving surgery."

"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."

"Prelude Corporation (PreludeDx™)...has unveiled data from an analysis of over 700 early-stage invasive breast cancer patients for AidaBreast™ - a novel biosignature that predicts 10-year recurrence rate and radiation therapy (RT) benefit - at the 41st Annual Miami Breast Cancer Conference (MBCC)."

"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."

P=NA | N=NA | "Prelude Corporation...announced it will be presenting data on a novel biosignature that predicts radiation therapy (RT) benefit in invasive (Stage I, II) breast cancer patients. 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....While RT following breast conserving surgery was associated with a reduction for recurrence rates (HR=0.3, 95%CI [0.1, 0.5], p<0.001) in the overall patient population, in multivariable analysis, the biosignature was predictive for RT benefit adjusted for clinicopathologic factors, where patients identified as 'Residual-Risk' by the biosignature had a higher ipsilateral breast recurrence rate after RT compared to other risk groups with a positive interaction with RT (HR=3.7 95%CI [1.6,8.7], p=.0026)."

"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.'"

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."

"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."

"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)."

"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."

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."

"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."

"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."

"Prelude Corporation...announced compelling results in 926 women diagnosed with ductal carcinoma in situ (DCIS). The new information was presented in an oral presentation at the American Society of Breast Surgeons (ASBrS) 23rd Annual Meeting, held on April 6 - 10, 2022 at Wynn Las Vegas, NV...DCISionRT identified women with a low 5% 10-yr risk of recurrence with or without radiation therapy: overall and within either high-grade or young patients. Furthermore, the test predicted which patients had a superior benefit from radiation therapy (>70% relative risk reduction)."

"Prelude Corporation...announced today that its study in 926 patients demonstrating the clinical utility of DCISionRT and its Residual Risk Subtype (RRt) was selected for a scientific session oral presentation at the American Society of Breast Surgeons (ASBrS) 23rd Annual Meeting. The results assessing 10-year risk of ipsilateral breast recurrences in patients with grade 3 ductal carcinoma in situ (DCIS) disease and/or young age (<50 years) treated with breast conserving surgery (BCS) with or without radiation therapy (RT), will be presented on April 9, 2022 at Wynn Las Vegas, NV."

"Prelude Corporation...announced that it has closed a $20 million funding round led by Evidity Health Capital and joined by existing and new investors...Proceeds from this round will be used to advance the commercial market expansion of DCISionRT and the continued development of the company’s precision radiogenomics platform for early-stage breast cancer and other cancers."

"Prelude Corporation (PreludeDx), announced it will be presenting data comparing DCISionRT and its integrated Residual Risk subtype (RRt) with traditional clinicopathology features at the 39th Annual Miami Breast Cancer Conference (MBCC), being held on March 3 – 6, 2022 at the Fontainebleau Miami Beach...The poster is entitled, ‘Clinicopathological Risk Factors Poorly Stratified Baseline Risk and RT benefit Compared to DCISionRT in Patients with Ductal Carcinoma in Situ’ and will be available online for viewing during the duration of the conference and available in-person during the poster receptions on March 3rd and 4th."

"Prelude Corporation...announced the publication of SweDCIS randomized clinical trial data in the Special Issue Updates on Breast Cancer edition of Cancers. The randomized study demonstrates that the DCISionRT test predicts radiation benefit for reducing 10-year local invasive breast cancer risk...The study 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."

"Prelude Corporation...announced today it will be presenting new data on its ongoing prospective PREDICT study of DCIS patients at the 2021 San Antonio Breast Cancer Symposium (SABCS), being held on December 7 – 10 at the Henry B. Gonzalez Convention Center in San Antonio, Texas. PreludeDx will present scientific data demonstrating a significant (40%) change in radiation therapy (RT) treatment recommendations when using the DCISionRT test."

"Prelude Corporation (PreludeDx)...announced today that the American Medical Association (AMA) has issued a new, dedicated Current Procedural Terminology (CPT®) Proprietary Laboratory Analyses (PLA) code for DCISionRT, the only test available to predict personalized recurrence risk and radiation therapy benefit for patients with ductal carcinoma in situ (DCIS). The new code 0295U, will become effective January 1, 2022 and is specific to the DCISionRT test."