On May 22, 2025 Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., reported new data demonstrating the significant clinical impact of the Breast Cancer Index (BCI) test, which will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2025 (Press release, Hologic, MAY 22, 2025, View Source [SID1234653344]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"These data highlight the critical role the Breast Cancer Index test plays in guiding extended endocrine therapy decisions for women with early-stage, hormone receptor-positive (HR+) breast cancer," said Jennifer Schneiders, PhD, President of Diagnostic Solutions at Hologic. "As the only genomic test recognized by clinical practice guidelines to inform such decisions, the BCI test is a powerful tool in personalized care. These findings reinforce our commitment to delivering clinically validated diagnostics that support treatment decisions based on each patient’s unique tumor biology."

During the meeting, Hologic will share the latest analysis of the prospective, multi-center BCI Registry Study, which evaluated how the BCI test influences clinical decision-making for extended endocrine therapy in patients with early-stage, HR+ breast cancer. Building on initial published data, this assessment reflects an even more comprehensive analysis of more than 2,800 patients. The latest data showed BCI testing led to a change in treatment recommendations for about 4 in 10 cases. Importantly, physician confidence in treatment recommendations also increased and patients reported feeling more comfortable with their treatment decisions, citing fewer concerns about cost, drug safety and preference related to extended endocrine therapy benefit.1

"Incorporating the Breast Cancer Index test into the conversation about extended endocrine therapy helps doctors and patients make decisions with more confidence and comfort," said Tara Sanft, MD, Associate Professor of Medicine at Yale School of Medicine and primary investigator of the new study. "As oncologists, we often look at clinical and pathologic factors to assess our patients’ risk of recurrence, but these factors are not enough to tell us whether longer treatment is likely to reduce that risk and may lead to misguided recommendations. Genomic testing with the BCI test allows us to determine which women are likely to derive benefit from extended endocrine therapy to make more informed, shared decisions with our patients."

The data presentations at ASCO (Free ASCO Whitepaper) 2025 focusing on the BCI test include:

Prospective Decision Impact Study of the Breast Cancer Index: Results from the BCI
Registry Study (Abstract #531/Poster Board #124)
Monday, June 2, 9 a.m.-12 p.m. CT; Breast Cancer — Local/Regional/Adjuvant Poster Session, Hall A
The expanded assessment of the BCI Registry Study found that incorporating the BCI test into clinical practice significantly influenced extended endocrine therapy decisions for early-stage, HR+ breast cancer patients.1
Assessment of Ovarian Function Suppression (OFS)-Containing Adjuvant
Endocrine Therapy in Premenopausal Women by Breast Cancer Index (Abstract #557/Poster Board #150)
Monday, June 2, 9 a.m.-12 p.m. CT; Breast Cancer — Local/Regional/Adjuvant Poster Session, Hall A
These translational data from the landmark Tamoxifen and Exemestane Trial (TEXT) trial further validate the ability of the BCI test to assess risk of overall and late distant recurrence in premenopausal women with early-stage, HR+ breast cancer.2*
About the Breast Cancer Index Test

The Breast Cancer Index test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. The Breast Cancer Index test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO (Free ASCO Whitepaper) Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) acknowledge the Breast Cancer Index test as a biomarker to help inform extended endocrine treatment decisions.3,4 It is the only test recognized by guidelines to predict the likelihood of benefit from extended endocrine therapy.3,4

The Breast Cancer Index test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a laboratory-developed test (LDT) performed in a single CLIA-certified and CAP-accredited diagnostic laboratory. For more information, visit www.breastcancerindex.com.

On May 22, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company and its research collaborators will present data from more than 19 studies, including a landmark plenary session on the Phase 3 SERENA-6 trial, demonstrating the critical role of Guardant liquid biopsy tests in cancer screening, therapy selection and recurrence monitoring at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Guardant Health, MAY 22, 2025, View Source [SID1234653343]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Featured presentations demonstrate the use of Guardant’s portfolio of blood tests, real-world data and AI to identify genomic and epigenomic biomarkers that can inform treatment decisions across a variety of solid tumor types. Studies also highlight new capabilities of the Guardant360 Liquid test to identify molecular tumor type in carcinomas of unknown primary and confirm the absence of actionable biomarkers, both enabled by the Guardant Infinity smart liquid biopsy platform, Presentation highlights include:

Abstract LBA4 plenary session demonstrating the use of the Guardant360 CDx test in detecting emergent ESR1 mutations during first-line endocrine-based therapy and ahead of disease progression in patients with HR+/HER2- advanced breast cancer in the Phase 3 SERENA-6 trial
Abstract 3504 oral session evaluating tissue-free epigenomic-based molecular residual disease (MRD) detection using Guardant Reveal in stage III colon cancer patients after surgery and prior to adjuvant therapy. This study showed a robust prognostic utility of Reveal to identify patients with poorer disease-free and overall survival in a large clinical trial cohort of over 2,000 patients with a median follow-up of 6.1 years.
Abstract 3584 providing analytic and clinical validation of an algorithm to predict the absence of actionable mutations in ctDNA-negative colorectal and non-small cell lung cancer samples, utilizing genomic and epigenomic profiling with the Guardant360 Liquid test.
Abstract 3073 demonstrating application of an epigenomic-based classifier to identify tumor type on liquid biopsy in cancer of unknown primary origin. Study provides validation data for the new molecular tumor type feature of Guardant360 Liquid utilizing DNA methylation signatures across thousands of cancer-specific differentially methylated regions for 14 cancer types.
"The data we and our research colleagues are presenting at ASCO (Free ASCO Whitepaper) demonstrate the clear and growing contribution of liquid biopsy in transforming cancer care and helping to improve patient outcomes," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "The SERENA-6 study in particular highlights how we are pushing the boundaries of what can be done with liquid biopsy in characterizing disease and potential drug efficacy, providing insights that could potentially change clinical practice."

The full abstracts for Guardant Health and a list of all abstracts being presented at ASCO (Free ASCO Whitepaper) 2025 can be found on the ASCO (Free ASCO Whitepaper) website.

For information and updates from the conference, follow Guardant Health on LinkedIn, X (Twitter) and Facebook or visit ASCO (Free ASCO Whitepaper) booth #25077.

Guardant Health and collaborator presentations at ASCO (Free ASCO Whitepaper)

Abstract/Poster

Title (Hall A unless otherwise noted)

Product

Friday, May 30, 2:45 pm – 5:45 pm CT (Arie Crown Theater, Live Stream)

3504

Oral Abstract Session: Tissue-free circulating tumor DNA assay and patient outcome in a phase III trial of FOLFOX-based adjuvant chemotherapy (Alliance N0147)

Guardant Reveal

Saturday, May 31, 9:00 am – 12:00 pm CT

3584/253

Analytic and clinical validation of a negative prediction algorithm for actionable mutations utilizing genomic and epigenomic profiling in cfDNA

Guardant360 Liquid

4200/490

Circulating tumor DNA-based genomic profiling and real-world outcomes in cancer of unknown primary (CUP)

Guardant360 Liquid

GuardantINFORM

Saturday, May 31, 1:30 pm – 4:30 pm CT

8528/8

Genomic and circulating tumor DNA landscape in young-onset non-small cell lung cancer

Guardant360 Liquid

8642/122

Use of targeted therapy, healthcare costs, and survival with large panel testing, narrow testing, or no molecular testing in patients with metastatic non-small cell lung cancer (mNSCLC)

Guardant360 Liquid

Guardant360 CDx

10550/275

Validation of a plasma cell-free DNA methylation-based multi-cancer detection test

Shield MCD

Sunday, June 1, 2:41 pm – 2:53 pm CT (Plenary Session, Hall B1, Live Stream)

LBA4

Oral Clinical Science Symposium: Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial

Guardant360 CDx

Sunday, June 1, 4:30 pm – 6:00 pm CT (Arie Crown Theater, Live Stream)

1012

Oral Clinical Science Symposium: Assessment of ctDNA somatic homologous recombination deficiency (HRD) in triple-negative breast cancer (TNBC) from SWOG S1416 trial

Guardant OMNI

Monday, June 2, 9:00 am – 12:00 pm CT

1052/31

Circulating tumor DNA (ctDNA)-based minimal residual disease (MRD) measured by Guardant Reveal in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) with long-term disease control on first-line trastuzumab-pertuzumab

Guardant Reveal

1075/54

Use of baseline plasma circulating tumor DNA (ctDNA) to predict duration of endocrine therapy (ET) and CDK4/6 inhibitor (CDK4/6i) therapy (tx) and to analyze intrinsic vs acquired endocrine resistance

Guardant360 Liquid

5052/251

Evaluating the prognostic utility of cell-free (cf)DNA tumor fraction (TF) in metastatic castration-resistant prostate cancer (mCRPC)

Guardant360 Liquid

5053/252

Real world outcomes for patients with metastatic castration resistant prostate cancer (mCRPC) and AR T878A alterations treated with enzalutamide

GuardantINFORM

5077/276

Real-world prevalence of homologous recombination repair alterations (HRRa) and poly (ADP-ribose) polymerase inhibitor (PARPi) use/outcomes in patients (pts) with metastatic prostate cancer (mPC) by race and ethnicity

GuardantINFORM

5086/285

Association between epigenomic biomarkers and baseline clinical characteristics in patients with mCRPC treated with rucaparib in TRITON2

Guardant Infinity

Monday, June 2, 1:30 pm – 4:30 pm CT

3073/388

Application of an epigenomic-based classifier to identify cancer signal of origin on liquid biopsy in cancer of unknown primary cases

Guardant360 Liquid

3074/389

HRD status prediction in patients with advanced breast, prostate, ovarian and pancreatic cancers in a liquid biopsy assay

Guardant360 Liquid

Tuesday, June 3, 8:30 am CT

5512

Oral Abstract Session: Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer: Longitudinal changes in circulating tumor DNA

Guardant Infinity

Online Abstracts

e20536

Accelerating treatment decisions with liquid biopsy NGS in non-small cell lung cancer

Guardant360 Liquid

e13084

Targeted agents for the treatment of hormone receptor–-positive, human epidermal growth factor receptor 2–negative metastatic breast cancer (HR+/HER2- MBC) with co-alterations in ESR1 and AKT pathway: A retrospective analysis

Guardant360 Liquid

On May 22, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that data from more than 25 Signatera studies will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 30 – June 3, 2025 in Chicago, IL (Press release, Natera, MAY 22, 2025, View Source [SID1234653342]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Together with its collaborators, Natera will showcase the clinical utility of Signatera across 10 different cancer types. This extraordinary breadth of data includes analyses of thousands of patients, demonstrating Natera’s leadership in circulating tumor DNA (ctDNA) monitoring and molecular residual disease (MRD) assessment.

"The depth and breadth of Natera’s research at ASCO (Free ASCO Whitepaper) is our most significant to date, with multiple impactful datasets in several histologies," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "The interim analysis from the DARE trial shows a possible first signal in a randomized setting that treating high-risk breast cancer patients based on Signatera results can impact clearance rates. We also look forward to sharing results on our ultra-sensitive Signatera Genome assay, along with numerous other presentations underscoring our commitment to advance the way cancer is managed."

Highlights include:

DARE Clinical Trial: Oral Presentation
DARE is a prospective, randomized study, launched in 2021, to investigate the utility of Signatera for guiding adjuvant endocrine therapy in 585 women with high-risk, estrogen receptor-positive, HER2-negative (ER+/HER2-) breast cancer. It assesses the novel concept of "treatment on molecular recurrence" (TOMR). Patients who were Signatera-positive and imaging-negative were randomized into two arms: the standard-of-care (SOC) arm with endocrine therapy vs. the escalated arm with fulvestrant+palbociclib (CDK 4/6i). This interim analysis of 507 women and 2,208 plasma samples demonstrates the exceptional clinical performance of Signatera, and the early feasibility of both this treatment escalation approach and the TOMR trial strategy, including:
Strong test sensitivity and NPV: Among patients who remained persistently Signatera-negative during screening (>400 pts), 99% remained recurrence free with a median follow up of 27.4 months.
High randomization rate: Of patients who tested Signatera-positive, 73% were negative on imaging, and 93% were willing to be randomized.
2x higher ctDNA clearance: Patients in Arm A had a 2x higher rate of ctDNA clearance at 3 months vs. Arm B.
Signatera Monitoring in Metastatic Breast Cancer: Oral Presentation
This real-world analysis of over 600 metastatic breast cancer (mBC) patients across all disease subtypes and a wide range of therapeutic regimens (e.g., chemo, ADCs, CDK4/6) shows the utility of metastatic monitoring with Signatera:
Serial ctDNA testing done at an appropriate cadence (6 weeks) can inform treatment response and clinical decisions in metastatic breast cancer.
Signatera ctDNA dynamics were the strongest predictor of treatment benefit in a multivariate analysis, based on measuring time to next treatment (TTNT).
Nearly 75% of patients with favorable dynamics remained on the same treatment for over 4 months, including those receiving antibody drug conjugates (ADCs) where therapy response can be challenging to evaluate on imaging.
Pan-Cancer Performance of Signatera Genome: Poster Presentation
Large-scale presentation of Signatera’s Genome assay, analyzing more than 3,000 samples from over 300 patients across 5 major cancer types.
The study includes analysis of patients with breast cancer, colorectal cancer, non-small cell lung cancer, melanoma, and renal cell carcinoma.
Signatera Performance in Post-Surgical Stage I-IIIb Melanoma: Poster Presentation
This study includes 197 patients and 1,681 plasma samples, tested for a median period of 2 years. This is one of the most comprehensive MRD/monitoring datasets thus far in early melanoma, demonstrating the ability of Signatera to identify patients who may benefit from escalated imaging or earlier treatment initiation.
Post-surgical Signatera-positivity was the most significant predictor of recurrence free survival (RFS).
In the surveillance setting, Signatera-positivity was predictive of shorter RFS (HR: 24.0, P < 0.001).
Full list of oral presentations at ASCO (Free ASCO Whitepaper):

May 30, 2:45 PM CT | 3008 | Breast
Presenter: Silver Alkhafaji
Circulating tumor DNA (ctDNA) in patients with stage 2/3 HR+HER2-negative breast cancer (BC) treated with neoadjuvant endocrine therapy (NET) in the I-SPY2 endocrine optimization pilot (EOP) trial

June 1, 9:45 AM CT | 4503 | Genitourinary
Presenter: Thomas Powles, MBBS, MRCP, M.D.
Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA

June 1, 11:30 AM CT | 3518 | Gastrointestinal
Presenter: Aron Bercz, M.D.
Circulating Tumor DNA Provides an Early Response Assessment in Anal Squamous Cell Carcinoma Treated With Definitive Chemoradiation

June 1, 4:30 PM CT | 1010 | Breast
Presenter: Lajos Pusztai, M.D., DPhil
Circulating tumor (ct)DNA monitoring of ER+/HER2- high-risk breast cancer (BC) during adjuvant endocrine therapy (ET) (DARE)

June 1, 4:30 PM CT | 1011 | Breast
Presenter: Pedram Razavi, M.D., Ph.D.
Circulating tumor DNA (ctDNA) dynamics as a predictor of treatment response in metastatic breast cancer (mBC)

June 2, 3:00 PM CT | 504 | Breast
Presenter: Rita Mukhtar, M.D.
Predicting nodal burden after neoadjuvant chemotherapy (NAC) with circulating tumor (ct)DNA for surgical planning: Results from the I-SPY2 trial

Full list of poster presentations at ASCO (Free ASCO Whitepaper):

May 31, 9:00 AM CT | 11537 | Sarcoma
Presenter: Adie Victor, M.D., M.S.
Early on-treatment circulating tumor (ct)DNA dynamics in response to therapy in patients with sarcoma

May 31, 9:00 AM CT | 11531 | Sarcoma
Presenter: Maggie Zhou, M.D.
Early assessment of response to chemotherapy via ctDNA in soft tissue sarcoma

May 31, 9:00 AM CT | TPS3647 | Gastrointestinal
Presenter: Clara Montagut, M.D.
A precision medicine trial leveraging tissue and blood-based tumor genomics to optimize treatment in resected stage III and high-risk stage II colon cancer (CC) patients (pts): The SAGITTARIUS Trial.

May 31, 9:00 AM CT | 4067 | Gastrointestinal – FMI
Presenter: Michele Prisciandaro, M.D.
Tumor-informed liquid biopsy in predicting recurrence in patients with operable gastroesophageal adenocarcinoma: the LIQUID study

May 31, 9:00 AM CT | 4130 | Gastrointestinal
Presenter: Maen Abdelrahim, M.D.
Real-world analysis of ctDNA and other biomarkers in patients with curatively resected Stage I-III Biliary Tract Cancer

May 31, 9:00 AM CT | 3600 | Gastrointestinal
Presenter: Eiji Oki, Ph.D.
Impact of Perioperative Complications on ctDNA-based MRD Detection and Prognosis: Insights from the GALAXY Study

May 31, 9:00 AM CT | 3591 | Gastrointestinal
Presenter: Emerik Osterlund, M.D., Ph.D.
Biologic correlates of circulating tumor DNA (ctDNA) shedding in the INTERCEPT colorectal cancer (CRC) study

May 31, 9:00 AM CT | 3597 | Colorectal
Presenter: Midhun Malla, M.D., M.S.
ctDNA dynamics and targeted therapies associated with genetic mutations in patients with colorectal cancer

May 31, 9:00 AM CT | 4073 | Esophagogastric Gastric
Presenter: Reetu Mukherji, M.D.
Exome analysis of over 5000 esophagogastric cancers

June 1, 9:00 AM CT | 9574 | Merkel Cell Carcinoma
Presenter: Joshua Elbridge Chan
Comparison of surveillance circulating tumor DNA and merkel polyomavirus antibody titer for detection of merkel cell carcinoma recurrence

June 1, 9:00 AM CT | 9571 | Melanoma
Presenter: George Ansstas, M.D.
Longitudinal ctDNA monitoring for post-surgical molecular residual disease in patients with stage I-IIIb melanoma

June 1, 9:00 AM CT | 9523 | Melanoma
Presenter: Caroline Burkey
Circulating tumor DNA (ctDNA) dynamics during anti-PD-1 based therapy to predict clinical outcomes in advanced stage melanoma: A multicenter retrospective study.

June 1, 9:00 AM CT | 9584 | Melanoma
Presenter: Vincent The-Luc Ma
Sensitivity of circulating tumor DNA (ctDNA) for disease recurrence or relapse in melanoma patients

June 1, 9:00 AM CT | 5563 | Gynecological
Presenter: Jung-Yun Lee, M.D., Ph.D.
ctDNA monitoring in participants with ovarian cancer treated with neoadjuvant pembrolizumab (pembro) plus chemotherapy (chemo) with or without the anti–immunoglobulin-like transcript 4 (ILT4) monoclonal antibody MK-4830

June 2, 9:00 AM CT | 4565 | Genitourinary
Presenter: Adanma Ayanambakkam, M.D.
Association of Tumor-Informed ctDNA-based Molecular Residual Disease (MRD) with Clinical Outcomes for Upper Tract Urothelial Cancer (UTUC)

June 2, 9:00 AM CT | 4602 | Genitourinary
Presenter: Ilana Epstein
Correlation of circulating tumor DNA (ctDNA) dynamics with clinical response in muscle-invasive bladder cancer (MIBC) patients (pts) undergoing trimodality therapy (TMT)

June 2, 9:00 AM CT | 4560 | Genitourinary
Presenter: Kevin R. Reyes, BS
Circulating tumor DNA (ctDNA) monitoring in patients (pts) with advanced urothelial carcinoma (aUC) treated with Enfortumab Vedotin +/- Pembrolizumab (EVP)

June 2, 9:00 AM CT | TPS620 | Breast
Presenter: Michail Ignatiadis, M.D., Ph.D.
EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA)

June 2, 9:00 AM CT | 581 | Breast
Presenter: Julia Foldi, M.D., Ph.D.
Serial circulating tumor DNA (ctDNA) monitoring in early-stage, HR+/HER2-, invasive lobular carcinoma (ILC) of the breast and impact on clinical outcomes

June 2, 9:00 AM CT | 560 | Breast
Presenter: Marla Lipsyc-Sharf, M.D.
Cadence of circulating tumor DNA (ctDNA) testing for molecular surveillance in early-stage breast cancer (eBC)

June 2, 9:00 AM CT | 612 | Breast
Presenter: Mei Wei, M.D.
I-SPY2 endocrine optimization pilot (EOP): Neoadjuvant lasofoxifene (Laso) in molecularly selected patients with hormone receptor positive (HR+)/HER2 negative (HER2-) stage 2/3 breast cancer (BC)

June 2, 1:30 PM CT | 3142 | Pancancer
Presenter: Mridula George, M.D.
Clinical performance of Signatera Genome assay in a cohort of patients (pts) with solid tumors

June 2, 1:30 PM CT | 3048 | Gastrointestinal
Presenter: John Paul Y.C. Shen, M.D.
Development of a methylation-based, tissue-free test for the detection of molecular residual disease by circulating tumor DNA

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

On May 22, 2025 Flatiron Health reported 14 abstracts leveraging its high-quality real-world oncology data have been accepted for poster presentation and online publication at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Flatiron Health, MAY 22, 2025, View Source [SID1234653341]). These studies exemplify Flatiron’s commitment to advancing cancer research and align with this year’s ASCO (Free ASCO Whitepaper) theme, "Driving Knowledge to Action: Building a Better Future," by delivering critical evidence to inform and improve patient care.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"AI and related technologies have enabled us to unlock data and insights from our entire network of over five million people with cancer, providing unprecedented scale, efficiency, and innovation for both real-world evidence generation and clinical trial execution," said Stephanie Reisinger, Senior Vice President & General Manager, Real-World Evidence. "Our research accepted at this year’s ASCO (Free ASCO Whitepaper) demonstrates our lasting commitment to deliver actionable evidence and improve care for every person with cancer."

Highlights include:

a poster presentation utilizing advanced machine learning models to identify a cohort of over 195,000 to complete the largest real-world study to date examining ctDNA testing in early stage breast cancer
an abstract assessing how often PSMA-PET scans were used among non-Latinx/Hispanic White, Black, and Latinx patients with metastatic prostate cancer
an abstract demonstrating the potential of a centralized, tech-enabled screening service to make clinical trial enrollment and more efficient, particularly in community oncology settings
Schedule a meeting with Flatiron Health at ASCO (Free ASCO Whitepaper) 2025, and learn more about our abstracts and events, including workshops and panels.

Follow Flatiron Health on X and LinkedIn for more updates from #ASCO25 and visit us in person at Booth #11131.

Abstracts and Poster Presentations
Racial and ethnic differences in biomarker testing for targetable alterations among patients with HR+ HER2- metastatic breast cancer (mBC)
Catherine Keane, Gene G. Ho, Samantha Reiss, Melissa Estevez, Katherine Harrison, Anca Marinescu, Olive Mbah
Breast Cancer—Metastatic
Poster board: 63
Abstract number: 1084

Real-world (rw) ctDNA testing trends and associated outcomes in patients (pts) with early stage breast cancer (EBC)
Erin Fidyk, Patrick Ward, Melissa Estevez, Konstantin Krismer, John Ritten, Anca Marinescu, Aaron B. Cohen
Breast Cancer—Local/Regional/Adjuvant
Poster board: 148
Abstract number: 555

Real-world patient (pt) characteristics, treatment patterns, and overall survival (OS) in metastatic hormone-sensitive prostate cancer (mHSPC): insights by PTEN status
Partners: Memorial Sloan Kettering Cancer Center, AstraZeneca
Dana Rathkopf, Danni Zhao, Lana Kovacevic, Jenna Collins, Eunice Hankinson, Helen Marshall, Aaron Springford, Simran Shokar, Helene von Bandemer, Weiyan Li
Genitourinary—Prostate, Testicular, and Penile
Poster board: 295
Abstract number: 5096

Impact of social determinants of health on mortality in diffuse large B-cell lymphoma (DLBCL) using real-world data
Partners: Yale School of Medicine, University of Alabama at Birmingham, Fox Chase Cancer Center, University of Texas Southwestern Medical Center, University of Colorado at Anschutz
Maureen Canavan, Mengru Wang, Olive Mbah, Maneet Kaur, Michael J. Hall, Adeel Khan, Jessica McDermott, Madeline Schmitter, Anosheh Afghahi, Gaurav Goyal
Quality Care/Health Services Research
Poster board: 436
Abstract number: 11097

Real-world surgical and treatment patterns after neoadjuvant checkpoint inhibition in US patients with stage II/III non-small cell lung cancer
Partners: UCLA, AstraZeneca, Memorial Sloan Kettering Cancer Center, The University of Chicago
Jay Lee, Daniel Simmons, Tiernan Mulrooney, Jeremy Snider, Lana Natalija Kovacevic, Karen Schwed, Aditya Juloori
Lung Cancer—Non–Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Poster board: 199
Abstract number: 8078

Molecular residual disease (MRD) in solid tumors
Partners: Taylor Cancer Research Center, Exact Sciences, Case Comprehensive Cancer Center
Majd T. Ghanim, John Nemunaitis, Tara Marti, Abhishek Dabral, Katherine Diaz-MacInnis, Judith Frederick, Marla Kuleszynski, Yichen Lu, Amanda Rodriguez-Sullivan, Melanie Palomares, Natalie Salituro, Soma Subramaniam, Anthony Tate, Kathleen Turnbull, Neal J. Meropol
Therapeutics—Molecularly Targeted Agents and Tumor Biology
Poster board: 486b
Abstract number: TPS3186

Assessment of racial/ethnic inequities in uptake of Prostate Specific Membrane Antigen – Positron Emission Tomography (PSMA-PET) scans among patients with metastatic prostate cancer in the United States (US)
Eunice A. Ochuonyo, Samantha Reiss, Patrick J. Ward, Brooke A. Jarrett, Olive Mbah, Prakirthi Yerram, Laura Rivera-Reyes, Sophia Miller, Kelly Magee, Lynn Rosario, Wendy Wittman, Cleo A. Ryals
Online publication only

Accrual of racially and ethnically underrepresented populations with multiple myeloma associated with centralized patient screening in a multicenter study
Partners: University of Colorado, Johnson & Johnson, New York Cancer and Blood Specialists
Anosheh Afghahi, Daniel Sanchez, Yichen Lu, Richard M. Zuniga, Laura Heste, Dina Gifkins, Britney Beaulieu, Catharine Cipolla, Barry Leybovich, Debra Mitchell, Jeffrey Nan, Ebube Onwasigwe, Hemang Patel, Paul Salcuni, Chloe Salzman, Neal J. Meropol, Ashita S. Batavia
Online publication only

A retrospective real-world study of first-line PD-(L)1 inhibitor use in patients with metastatic non-small cell lung cancer (mNSCLC)
Partner: Incyte
Kim Saverno, Siobhan Halloran, Mark Guinter, Kelly Magee, Michael Ondovik, J.E. Hamer-Maansson, Mark Cornfeld, Mihaela Munteanu
Online publication only

A retrospective cohort study of real-world clinical outcomes in patients with CLL/SLL previously treated with covalent BTK inhibitor (cBTKi) and BCL2 inhibitor (BCL2i) regimens
Partners: Merck & Co, MSD UK, Mayo Clinic
Jennifer Prescott, Christina Parrinello, Ahmed Sawas, Enrico De Nigris, Jing Yang, Erik Bloomquist, Indu Shrivastava, Changxia Shao, Xinyue Liu, Mohammed Farooqui, Sameer A. Parikh
Online publication only

Management and outcomes of rash, peripheral neuropathy (PN), and hyperglycemia (HG) during first-line (1L) treatment (Tx) of locally advanced/metastatic urothelial cancer (la/mUC) in a real-world setting
Partners: Cleveland Clinic, Merck KGaA, EMD Serono
Amanda Nizam, Mairead Kearney, Valerie Morris, Seyed Hamidreza Mahmoudpour, Carroline Lobo, Chiemeka Ike, Jason Hoffman, Ilian Iliev, Prakirthi Yerram, Mark Guinter
Online publication only

Concordance of response-based clinical trial and machine learning–generated real-world end points
Partner: Genentech
Qianyi Zhang, Konstantin Krismer, Yichen Lu, Qianyu Yuan, Aaron Dolor, Auriane Blarre, Aaron B. Cohen, Tori Williams, Sophia Maund, Minu K. Srivastava, Kelly Magee
Online publication only

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On May 22, 2025 OncoSwab, a biotechnology company focused on early detection of cancer through non-invasive molecular testing, reported it has entered into a collaboration agreement with Mayo Clinic (Press release, Mayo Clinic, MAY 22, 2025, View Source [SID1234653340]). The agreement provides OncoSwab with access to clinical research expertise and know-how to support the development of its nasal swab-based diagnostic platform.

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The collaboration centers on enabling clinical validation of OncoSwab’s lead diagnostic test, which utilizes genomic biomarkers from nasal fluid to detect lung cancer and expanding the technology into additional indications.

"Our goal is to deliver accurate, accessible diagnostics that empower clinicians to detect cancer earlier and with greater ease" said Andrea Stephany Díaz, co-founder and CEO of OncoSwab.

Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.