On May 3, 2022 RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* for all stages of cancer, reported the enrollment of the first patient into its PREMIER registry, a prospective, real-world evidence clinical outcomes registry for patients with all stages of cancer, at the University of Texas (UT) Southwestern in Dallas (Press release, RefleXion Medical, MAY 3, 2022, View Source [SID1234613436]).

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The PREMIER registry was created to collect data to demonstrate the impact of the RefleXion X1 radiotherapy system, the first-ever system with onboard fast fan-beam KVCT, on patients with all solid tumor and lymphoma cancer types. The registry will expand to include BgRT procedures, a new radiotherapy treatment modality that uses signals detected from positron emission tomography (PET) to guide radiotherapy. The X1 is the first and only system designed with onboard PET detectors. The PREMIER registry will assess health-related quality of life, acute and long-term side effects in patients, and cancer-related outcomes.

"We believe that adapting radiotherapy plans based on how the tumor responds to the first radiation dose will be a key component in bringing together radiotherapy with drug therapies, such as targeted and immune-oncology agents," said Tu Dan, M.D., assistant professor in the Department of Radiation Oncology at UT Southwestern Medical Center. "However, to fully understand the utility of this approach, robust and accurate data collected through longitudinal endpoints in prospective registries, such as RefleXion’s PREMIER registry, are imperative."

The PREMIER registry will include extensive baseline data as well as follow-up data collected at the end of treatment, and then again at three, six, nine, 12, 18 and 24 months. The registry will enroll a minimum of 750 patients from a minimum of four sites throughout the United States.

"Our prospective registry will capture and organize an unprecedented level of data including patient, demographic, tumor, biomarker, imaging and treatment information for all stages of cancer," said Sean Shirvani, M.D., MPH, chief medical officer at RefleXion. "Our hope is that collecting this rich repository of information before, during, and after treatment will enable our clinical partners to investigate and identify the factors that best determine cancer outcomes, which may then arm patients with the information they need to make better decisions around their care."

Prospective registries define specific information and characteristics in advance, before data collection or the impacts of a treatment are known, including the check-in interval for patient follow-up. Known as longitudinal data over time, this improves data accuracy because it minimizes the dependency on patient recall. Therefore, prospective registries can draw closer associations between the treatment delivered and a patient’s outcome.

On May 3, 2022 Agendia, Inc., a commercial-stage company focused on empowering decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, reported the presentation of new data from ongoing clinical studies evaluating its comprehensive suite of genomic tests at the upcoming annual conference of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held June 3-7, 2022 in Chicago, Illinois (Press release, Agendia, MAY 3, 2022, View Source [SID1234613435]).

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The data underscores Agendia’s clinical commitment to full transcriptome analysis and treatment of breast cancer for underserved populations, in addition to numerous sub-studies stemming from the company’s FLEX Registry, the study in the real world, multicenter, prospective and observational on breast cancer. Two abstracts selected by ASCO (Free ASCO Whitepaper) for oral discussion will present an analysis of the ImPrint genomic test, which is currently indicated for research use only, the I-SPY series of assays, and an analysis of FLEX for receptor breast cancer. positive hormones in black women classified by BluePrint .

The company believes that the FLEX Registry’s approach to cancer research is accelerating the generation of relevant data, aimed at redefining cancer treatment. Its patient-centered design and nationwide network of participating sites leverage Agendia’s infrastructure, enabling investigator-initiated sub-studies to produce notable results with the potential to advance science, such as this. is the case of the data presented at ASCO (Free ASCO Whitepaper) 2022.

Below is information related to the nine Agendia abstracts that have been accepted for discussion or poster sessions at the 2022 ASCO (Free ASCO Whitepaper) Annual Conference:

Poster Discussion Sessions

ImPrint immune signature to identify patients at high risk for breast cancer who may benefit from PD1 checkpoint inhibition in I-SPY2
Authors: Kuilman, MM., et al.
Presenter: Lorenza Mittempergher, PhD | R&D, Agendia NV
Session: Breast cancer – local/regional/adjuvant
Poster discussion: Monday, June 6, 2022 | 1: 15-2:45 p.m. CDT
Abstract No.: 514
Full transcriptomic analysis of hormone receptor positive breast cancer in black women classified as basal type by BluePrint
Authors: Reid, S., et al.
Presenter: Sonya A. Reid, MD, MPH | Vanderbilt University Medical Center
Session: Breast Cancer – Local/Regional/Adjuvant
Poster Discussion: Monday, June 6, 2022 | 1: 15-2:45 p.m. CDT
Abstract No.: 517
Sessions per poster

Whole transcriptome analysis of tumors with a discordant oncotype and MammaPrint results in the FLEX trial
Authors: Socoteanu, M., et al.
Session: Breast cancer – local/regional/adjuvant
Session date and time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No.: 556
Clinical Implications for Patients with Discordant Oncotype and MammaPrint Results
Authors: Socoteanu, M., et al.
Session: Breast cancer – local/regional/adjuvant
Session date and time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No.: 560
Investigation of a genomic signature for gene amplification of the transcription factor MAF and insufficient benefits of bisphosphonate for early breast cancer
Authors: Nasrazadani, A., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Session Date and Time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No: 559
Identification of transcriptional changes with MammaPrint and BluePrint in early-stage breast cancer after neoadjuvant chemotherapy
Authors: Chung, A., et al.
Session: Breast cancer – local/regional/adjuvant
Session date and time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No.: 585
Distribution of Breast Cancer Molecular Subtypes Based on Receptor Classifications: Lessons from the I-SPY2 Trial and the FLEX Registry
Authors: Cha, J., et al.
Session: Breast cancer – local/regional/adjuvant
Session date and time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No.: 592
FLEX, the transcriptomic project for 30,000 breast cancers: a platform for early stage breast cancer research using comprehensive genomic testing coupled with clinical data
Authors: Ma, C., et al.
Session: to be confirmed Session
date and time: Monday, June 6, 2022 | 8h00-11h00 CDT
Abstract No.: TPS612
Defining transcriptomic profiles of early-stage mucinous breast cancers: a FLEX
substudy Authors: Sivapiragasam, A., et al.
Session: Developmental Therapeutics – Molecular Targeting Agents and Tumor Biology
Session Date and Time: Sunday, June 5, 2022 | 8h00-11h00 CDT
Abstract No: 3134
Agendia will be sharing important updates on its Twitter , Facebook and LinkedIn pages throughout the conference. The program for the event is available on the ASCO (Free ASCO Whitepaper) 2022 website .

On May 3, 2022 Agendia, Inc. , a commercial-stage company focused on facilitating optimized decision-making by providing clinicians with next-generation information and diagnostic solutions that can be used to help improve outcomes of breast cancer patients worldwide, reported that it will present new data at the European Society for Medical Oncology Breast Cancer Conference 2022 (ESMO Breast 2022) in Berlin, Germany, from 3 to May 5, 2022 (Press release, Agendia, MAY 3, 2022, View Source [SID1234613434]).

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The first of two poster presentations, titled Equivalence of NGS-based MammaPrint 70-gene signature risk of recurrence and BluePrint 80-gene signature of molecular subtyping tests to the centralized microarray tests [234P], concludes that the sequencing version MammaPrint and BluePrint [1] Next-Generation Microarray Testing (NGS) is equivalent to centralized microarray testing, as evidenced by results from several laboratories worldwide. This enables a more accurate decentralized solution for breast cancer care, promoting global accessibility to more reliable genomic tests.

"Accessibility to breast cancer care is crucial and by validating the interchangeability of the NGS version of MammaPrint and BluePrint compared to standardized microarray tests, it opens new doors for clinicians around the world who may need to rely on platforms in the country to secure the MammaPrint and BluePrint results that their patients may need," says Annuska Glas, Senior Vice President of Research and Development and Innovation at Agendia. "MammaPrint is a valuable tool to aid treatment planning for breast cancer patients and with the decentralized NGS platform, it can be offered in even more countries. These results confirm that MammaPrint and BluePrint can provide the same accurate results through of NGS," he adds.

Agendia is creating new ways to ensure accessibility of care around the world, advancing solutions with a decentralized option for test kits to run on an NGS platform, and innovative modalities such as AI digital pathology. This data presented at the ESMO (Free ESMO Whitepaper) Breast 2022 conference follows Agendia’s announcement earlier this year that it was advancing its Digital MammaPrint artificial intelligence (AI) platform in Brazil to potentially radically change the way breast cancer is treated, providing essential information faster and elevating the capabilities of global clinicians treating women with breast cancer in their local communities.

A second poster presentation, entitled Budget impact analysis for the Health Care Package by using MammaPrint in Belgium [238P],builds on earlier research from the landmark MINDACT trial and combines it with interim analysis results from the pilot study conducted in Belgium (unpublished data). The budget impact model shows that the use of MammaPrint results in savings in breast cancer care in Belgium for the Belgian health package compared to no gene expression profiling testing. According to the budget impact model, the use of MammaPrint in patients selected according to the criteria of the pilot study represents a great saving. If gene expression profiling were performed on all clinically high-risk patients, the savings would be even greater.

Combining the cost of genomic testing with the savings from the net reduction in chemotherapy use, the annual savings amount to more than €5.8 million, which is an average saving of €3,900 per patient, compared to standard clinical care of a patient with breast cancer in Belgium. MINDACT has carried out previous analyzes of health savings in several countries, published in the European Journal of Cancer ,showing that genomic testing is beneficial as it provides valuable information that potentially allows patients to avoid the complexity of chemotherapy, resulting in significant financial savings for them, while generating significant cost savings for large healthcare systems around the world.

"A partir de los datos de impacto utilizados en el estudio piloto realizado en Bélgica, podemos determinar nuevas ideas de que el uso de MammaPrint podría conceder un ahorro sustancial de costes a las mujeres que no requieran quimioterapia y, en última instancia, podría aliviar parte de la carga del sistema sanitario belga en su conjunto", señala Pino Cusumano, MD, cirujano de mama del Centre Hospitalier Chrétien de Lieja en Bélgica. "Los datos han demostrado previamente que al desescalar a las mujeres con casos de bajo riesgo del tratamiento de quimioterapia, los resultados siguen siendo igual de buenos y las mujeres pueden seguir un plan de tratamiento más personalizado. Creemos que estos datos demuestran que el análisis anterior es válido para el estado de la atención del cáncer de mama en Bélgica en 2022,and that the overall benefit to the patient extends beyond physical care, to financial well-being as well," he continues.

Taken together, the two posters presented at ESMO (Free ESMO Whitepaper) Breast 2022 suggest that no matter where a patient is located, she can receive the same high-quality results with the added benefit of cost-effective treatment planning.

"The studies presented at EMSO 2022 support Agendia’s key initiatives to ensure that our genomic tests are widely accessible and affordable, without compromising scientific integrity or decision-making, to provide the clarity that women with breast cancer seek to guide treatment planning," says Bastiaan van der Baan, Director of Clinical and Commercial Development at Agendia. "With our strong commitment to facilitating the global adoption of MammaPrint and BluePrint, we look forward to continuing studies like these to increase the evidence supporting our goal of caring for women with breast cancer throughout their treatment," he concludes.

1 The MammaPrint and BluePrint next-generation sequencing kits have not yet been cleared by the Food and Drug Administration for sale in the United States; BluePrint has received CE marking for use in Europe. BluePrint is also marketed as a Laboratory Developed Test (LDT) and is CAP/CLIA audited in the United States.

On May 3, 2022 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported it will host a conference call to discuss its financial results for the year ended December 31, 2021 today at 5 pm ET (Press release, Perimeter Medical Imaging AI, MAY 3, 2022, View Source [SID1234613433]).

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Details on company presentations and webcasts can be found on the "Investors" section of Perimeter’s website at View Source When available, webcasts will be posted for replay following the event. The above listed dates and times are subject to change.

On May 3, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, reported that the company will host a conference call and live audio webcast on Tuesday, May 10, 2022, at 8:00 a.m. ET to review its first quarter 2022 financial results and provide an update on the company (Press release, Gamida Cell, MAY 3, 2022, View Source [SID1234613432]).

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The webcast will be available on the "Investors & Media" section of the Gamida Cell website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 3344029. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.