Jan 18,2024 TOP STORY

Aptar Digital Health and Moffitt Cancer Center Launch Clinical Evaluation for Oncology Digital Therapeutic, Oleena®

Aptar Digital Health announced a collaboration with Moffitt Cancer Center, a leading U.S. cancer care and research institution, to conduct a clinical evaluation of Oleena®, Aptar Digital Health’s FDA approved and CE-marked digital therapeutic (DTx) for the management of symptoms in cancer care. The clinical evaluation, which will begin in February 2024 and run for a total period of 15 months, will primarily assess the usability of Oleena® by measuring key indicators such as patient satisfaction and engagement, as well as clinical outcomes including symptom burden, anti-cancer treatment adherence and quality of life. Under this clinical evaluation, head and neck cancer patients being treated with chemoradiation will use Aptar Digital Health’s Oleena® DTx to guide them in self-managing their symptoms.

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Jan 17,2024 TOP STORY

FDA Approves First AI-Powered Skin Cancer Diagnostic Tool

The FDA has approved the DermaSensor, the first AI-powered tool to diagnose skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma, at the point of testing and noninvasively. The DermaSensor is a wireless, handheld device that uses spectroscopy technology to examine lesions at cellular and subcellular levels, then analyze those characteristics using an FDA-cleared algorithm. The device was evaluated in the DERM-SUCCESS study which was led by the Mayo Clinic across 22 study centers and enrolled over 1000 patients. The DermaSensor device demonstrated a 96% sensitivity across all 224 types of skin cancers. Further, negative results from the DermaSensor had a 97% chance of being benign across all skin cancers. A companion clinical utility study also investigated the DermaSensor’s usage with 108 physicians. This study found that the device decreased the number of missed skin cancers by half (18% vs 9%). The FDA previously granted breakthrough device designation to DermaSensor in 2021.

REGULATORY FDA

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Jan 15,2024

SOPHiA GENETICS partners with Karkinos Healthcare to advance cancer research

Karkinos Healthcare will be advancing its research capabilities through a partnership with data-driven medicine company SOPHiA GENETICS which was announced on Monday. Together, the companies will help drive cancer testing and research for blood cancers and solid tumors to underserved areas in low and middle-income countries. Through this partnership, Karkinos will adopt the SOPHiA DDM Platform, which is powered by AI capabilities which standardize digital health data so it can be computed and analyzed to generate insights. The company plans to use SOPHiA GENETICS' technology to expand its offerings, advance its research, and streamline workflow for a variety of blood cancers, including Myeloid cancer and Lymphoma. In addition, the company will analyse solid tumours for a variety of cancer types including ovarian, prostate, breast, pancreas, lung, colorectal, skin, and brain cancers.

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Jan 15,2024

East Suffolk and North Essex NHS Foundation Trust joins LungIMPACT study of Qure.ai

East Suffolk and North Essex NHS Foundation Trust (ESNEFT) has joined the collaborative LungIMPACT study bringing UK academia, NHS hospitals and AI innovator Qure.ai together to gather real-world evidence of AI-assisted diagnosis of lung cancer. The ‘LungIMPACT’ trial is using Qure’s qXR solution to triage chest X-rays with the aim of identifying the presence of suspected lung abnormalities and give immediate reporting. This may then enable a patient to be referred for a CT scan faster if lung cancer is indicated, speeding up access to a confirmed diagnosis and treatment planning. Dr James Hathorn, Consultant Radiologist and Principal investigator for the study at East Suffolk and North Essex NHS Foundation Trust (ESNEFT), said: “There aren’t many big clinical research studies focused on artificial intelligence to prove its real worth, so we’re really excited to be part of this study to help find clinical evidence for the benefits. We want all AI products to be properly researched and evidenced so this is an important study for the future of healthcare.”

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Jan 16,2024

Qure.ai and Project Data Sphere Combine Big Pharma Insights with Deep AI to Drive Cancer Care Forward

Qure.ai and Project Data Sphere, a nonprofit initiative of the CEO Roundtable on Cancer, have announced their partnership to augment tumor assessments using AI-enabled solutions for clinical trials and cancer care. The focus of this collaboration is autoRECIST, a product of Project Data Sphere’s Images and Algorithms program. The program, initiated in consultation with the U.S. Food and Drug Administration, includes stakeholders and experts from across the pharmaceutical industry and academia. In collaboration with Qure.ai, autoRECIST will address the critical need for automating and standardizing tumor response assessments in medical imaging to enhance cancer treatment and research. Rooted in current imaging guidelines, this AI clinical tool will aid radiologists in the detection, selection, measuring and tracking of lesions using defined criteria.

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Jan 16,2024 TOP STORY

Lunit AI Solutions to Power Samsung's X-ray Devices for Advanced Chest Screening

Lunit announced a three-year supply contract with Samsung Electronics (Samsung Healthcare). The collaboration centers around the integration of Lunit's AI technology into Samsung's premium X-ray devices, elevating the accuracy and speed of chest screening. Under the terms of the contract, Lunit will supply Samsung Electronics with two AI-powered chest screening solutions: Lunit INSIGHT CXR and Lunit INSIGHT CXR Triage. The initial phase of this collaboration will see the X-ray devices, enhanced with Lunit's AI solutions, targeting the markets in the US, Canada, and Europe. Future phases aim to expand this to the Middle East, South America, and Southeast Asia, thereby broadening the global reach.

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Jan 17,2024 TOP STORY

Lunit INSIGHT CXR Excels in Long Nodule Detection - Exceptional Performance in Head-to-Head Study published in Radiology

The study led by a research team from Radboud University Medical Center, conducted a head-to-head validation of multiple commercial AI products from leading vendors, establishing Lunit INSIGHT CXR as the leading solution in the detection of lung nodules in chest X-rays. The study used radiographs from 386 patients, including 144 who had at least one nodule according to the reference standard CT image and were therefore considered true positive nodule cases; the remaining 242 were considered controls. 17 human readers, consisting of radiologists and radiology residents with varying experience levels, participated in the study. The mean AUC (Area Under the Curve) for human readers stood at 0.81, with a mean sensitivity of 71% and a mean specificity of 80%. Through the evaluation of seven commercially available CE-marked lung nodule detection algorithms on chest radiographs, Lunit INSIGHT CXR achieved the highest AUC (Area Under the Curve) of 0.93 in lung nodule detection, surpassing all other AI vendors and human readers (Mean AUC 0.81).

CLINICAL STUDY

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Jan 11,2024

UK study backs whole-genome screening for cancer care

A major new study in the UK has shown that combining whole-genome sequencing (WGS) and real-world clinical data at a national scale can help deliver tailored, personalised cancer therapy. Researchers from Genomics England, NHS England, Queen Mary University of London, Guy’s and St Thomas’ NHS Foundation Trust, and the University of Westminster analysed data from more than 30 types of solid tumour in 13,000 patients over a five-year period. Published in the journal Nature Medicine, the study showed various benefits of including WGS data from a simple blood test when assessing patients; for example, revealing that 90% of brain tumours and more than 50% of colon and lung cancers have genetic changes that could affect how patients are treated. The trial – said to be the largest of its kind – drew on the UK’s 100,000 Genomes Project and NHS records and has already led to calls for greater use of genomic testing in cancer care, as it can help select effective therapies for patients and avoid those more likely to cause serious side effects.

CLINICAL STUDY

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Jan 08,2024 TOP STORY

ConcertAI and NeoGenomics Announce Collaboration to Advance Hematological Research & Generative AI Solutions at 2024 JP Morgan Conference

ConcertAI and NeoGenomics, Inc., a leading oncology testing services company, announced a broad collaboration to advance large-scale hematological research solution to investigate real-world clinical practice and outcomes in hematological malignancies. Combining ConcertAI’s longitudinal clinical data with NeoGenomics’ comprehensive biomarkers derived from hundreds of hematological tests, the two copmanies are able to establish a robust and definitive real-world evidence (RWE) hematology solution. This is claimed to be the first population-scale hematology data set, which is both large and broad enough to minimize selection bias, to offer an actionable representation of the hematological prevalent disease in the US. The companies will be launching a hematology-focused collaborative version of ConcertAI’s Clinical Trial Optimization solution later in Q1, supporting study design and optimizing all aspects of trial planning, with multiple clinical development initiatives planned.

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Jan 08,2024 TOP STORY

Caris Life Sciences and Flatiron Health Partner to Create Transformational Real-World Data Offering

Caris Life Sciences and Flatiron Health announced a partnership to create a multimodal data offering to support and accelerate biopharmaceutical drug development and patient care. Combining the breadth and depth of Caris’ genomic, transcriptomic and imaging database with Flatiron’s longitudinal patient data and clinical outcomes, equips cancer researchers with comprehensive real-world data (RWD) offering at scale to power the next wave of cancer therapeutics. “This opportunity has the potential to create the largest and best-in-class clinical-omics dataset with Whole Exome and Whole Transcriptome sequencing coverage, expanding our opportunity to support biopharma in the preclinical stages of drug discovery and translation.” said Stephanie Reisinger, Senior Vice President and General Manager, Real-World Evidence, Flatiron Health.

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