May 10,2023

Lunit to Present 16 Abstracts at the 2023 ASCO Annual Meeting

Lunit (KRX:328130.KQ), a leading global provider of AI-powered cancer diagnostic solutions, today announced the presentation of 16 abstracts featuring its AI-biomarker platform at the American Society of Clinical Oncology (ASCO) Annual Meeting, to be held in Chicago, Illinois, on June 2-6.

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May 05,2023

Data supports DermaSensor skin cancer detection device

DermaSensor announced clinical data validating its handheld, non-invasive device for assisting in the detection of skin cancer. In collaboration with Mayo Clinic and the University of Connecticut School of Medicine, the company presented two studies. One demonstrated the standalone performance of DermaSensor’s novel elastic scattering spectroscopy (ESS) device. The other evaluated the impact of the device on primary care physicians’ (PCP) management of skin cancer. DermaSensor’s clinical validation study enrolled 1,005 patients across 22 primary care centers, evaluating 1,579 lesions in total. Dermatopathology evaluation confirmed 224 high-risk lesions, including melanomas, basal cell carcinomas, and squamous cell carcinomas. The ESS device achieved device sensitivity (95.5%) superior to that of the PCPs (83%).

CLINICAL STUDY

#connected device

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May 01,2023

Three Abstracts Focusing on the Clinical Utility of Veracyte’s Genomic Tests in ILD and Lung Cancer To Be Presented at ATS 2023 International Conference

Veracyte, Inc. (Nasdaq: VCYT) today announced that three abstracts focused on the company’s genomic tests for interstitial lung disease (Envisia Genomic Classifier) and lung cancer (Percepta Nasal Swab) will be presented at the American Thoracic Society (ATS) 2023 International Conference. The meeting will take place May 19-24 in Washington, D.C.

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May 01,2023

Tempus Receives U.S. FDA Approval for xT CDx, a NGS-Based In Vitro Diagnostic Device

Tempus, a leader in artificial intelligence and precision medicine, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s first Premarket Approval (PMA) application for its companion diagnostic test, xT CDx. xT CDx is a 648-gene next-generation sequencing test for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients. The test is intended as a companion diagnostic (CDx) to identify patients who may benefit from treatment with the targeted therapies listed in the Companion Diagnostic Indications table in accordance with the approved therapeutic product labeling. Additionally, xT CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with previously diagnosed solid malignant neoplasms.

REGULATORY FDA

#cdx

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Apr 29,2023

Findings From Two Large-Scale, Real-World Data Sets Reinforce Clinical Utility of Veracyte’s Decipher Prostate Genomic Classifier

Veracyte, Inc. (Nasdaq: VCYT) announced that new data presented at the American Urological Association (AUA) 2023 Annual Meeting validate the real-world performance and clinical utility of the company’s Decipher Prostate Genomic Classifier. The findings are from two separate, large-scale studies evaluating the Decipher Prostate test among a total of more than 100,000 individuals with prostate cancer and reinforce its role as a new standard of care to help inform treatment decisions for these patients. In the first study presented at AUA2023 (#MP44-17), researchers used data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database. Researchers linked data from 2,744 patients in the SEER registry who were tested with the Decipher Prostate test between 2016 and 2020. They then quantified the association of these patients’ Decipher Prostate test scores with receipt of surgery, upgrading, upstaging and adverse pathology at RP, and compared these associations to those of tumor volume, PSA, patient age and Gleason score at diagnosis. The result suggests that Decipher Prostate testing at the time of biopsy may improve risk stratification for prostate cancer patients with favorable-risk disease independent of tumor volume. Additionally, the findings suggest that patients with lower Decipher scores who have higher volume tumors may be suitable candidates for conservative management.

CLINICAL STUDY

#ai/software

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Apr 27,2023

Twist Bioscience and Aster Insights (previously M2GEN) Partner on Launch of Next Generation Oncology Panel for Cancer Research

Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, and Aster Insights, a bioinformatics company with the most advanced, direct-patient, lifetime-consented clinicogenomics data to accelerate oncology discovery research, today announced the availability of the AsterExome panel, which can simultaneously enable whole exome sequencing (WES) with additional coverage for target regions known to contain 620 genes associated with cancer. The AsterExome panel will be integrated into Aster Insights’ AVATAR program, which can enable informatics-based analysis of paired tumor and germline DNA and RNA sequencing data from patients consented via the Total Cancer Care® (TCC) protocol. Aster Insight’s real-world AVATAR data set comes from its Oncology Research Information Exchange Network® (ORIEN) partners

COLLABORATION PARTNERSHIP

#data & technology

#rwd

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Apr 27,2023

Veracyte Announces Five Abstracts Providing Molecular Insights Into Prostate and Other Cancers To Be Presented at the 2023 ASCO Annual Meeting

Veracyte, Inc. (Nasdaq: VCYT) today announced that five abstracts providing new molecular insights into prostate and other cancers will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago and online June 2-6.

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Apr 26,2023

Validation of the Integrated Prediction Model algorithm for outcome of cytoreduction in advanced ovarian cancer

The aim of the study is to validate the Integrated Prediction Model on a retrospective cohort of patients. The researchers previously developed the Integrated Prediction Model using a 4-step algorithm of unresectable stage IVB, patient factors, surgical resectability, and surgical complexity to predict outcome of <1 cm cytoreduction in advanced epithelial ovarian cancer, and triaged patients to neoadjuvant chemotherapy or primary cytoreductive surgery. A retrospective cohort study of 107 patients with advanced ovarian cancer treated between January 2017 and September 2018 was carried out. The study validated the proposal that a triage algorithm integrating patient factors, surgical complexity, and surgical resectability in advanced ovarian cancer had high sensitivity and specificity to predict optimal cytoreduction <1 cm.

CLINICAL STUDY

#ai/software

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Apr 25,2023

PathAI and ConcertAI Partner to Create First-in-class Histopathology and Curated Clinical Real-World Data Product

PathAI, a global leader in AI-powered pathology, and ConcertAI, a leader in AI software-as-a-service (SaaS) technology and real-world evidence (RWE) solutions for life sciences and healthcare, today announced a strategic partnership to launch a first-in-class quantitative histopathology and curated clinical real-world data (RWD) solution combining PathAI’s PathExplore™ tumor microenvironment panel with ConcertAI’s Patient360™ and RWD360™ products. Utilizing real world H&E-stained samples from PathAI’s pathology laboratory, PathExplore extracts quantitative measures of the tumor microenvironment, known as human interpretable features (HIFs), from whole slide images. These data are linked to Patient360’s reference-standard abstracted clinical EMR, medical claims, and Social Determinants of Health data, allowing direct insights into current standards of care and treatment dynamics. ConcertAI and PathAI will jointly offer these combined solutions to biopharma customers, including translational research and real-world data teams. The initial solutions focus on bladder cancer, colorectal cancer, prostate cancer, and melanoma.

COLLABORATION PARTNERSHIP

#data & technology

#rwd

#rwe

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Apr 21,2023

Welby Establishes “Oncology PHR Consortium” and Starts Joint Project for Clinical Implementation of PHR with National Cancer Center Hospital

Welby Co., Ltd. aims to realize patient-centered cancer treatment and improve treatment outcomes through PHR (Personal Health Record). In addition, as an initiative of the “Oncology PHR Consortium”, Welby has started a joint project with the National Cancer Center and other cancer treatment hospitals. The 4th Basic Plan for the Promotion of Cancer Control, which will start this fiscal year, calls for the promotion of digitalization as a foundation to support cancer prevention, cancer treatment, and coexistence with cancer.

COLLABORATION PARTNERSHIP

#institution

#rpm

#mobile app

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