Diagnostics

The New England Journal of Medicine Publishes Pivotal Tofersen Data that Show Benefits in Rare, Genetic Form of ALS

10/03/2022

Publication includes the Phase 3 VALOR SOD1-ALS trial and its open-label-extension study, underscoring the importance of these longer-term data 12-month data show earlier initiation of tofersen slowed decline across critical measures of function and strength in people diagnosed with SOD1-ALS Results offer important learnings regarding the biology of SOD1-ALS and design of ALS clinical trials…

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Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™

09/29/2022

SKOUT’s advanced computer vision capabilities enable physicians to detect pre-cancerous lesions in the colon with more accuracy Excerpt from the Press Release: CAMBRIDGE, Mass. & MINNEAPOLIS–(BUSINESS WIRE)–Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced today that SKOUT™…

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2seventy bio Announces Plans to Initiate KarMMa-9 Study of Abecma (idecabtagene vicleucel) in Newly Diagnosed Multiple Myeloma Patients

09/12/2022

This study will evaluate Abecma in patients with suboptimal response to transplant Data from KarMMa-3 and KarMMa-2 studies of Abecma will be presented at future medical meeting Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–2seventy bio, Inc. (Nasdaq: TSVT) today announced plans to initiate the KarMMa-9 study to evaluate Abecma (idecabtagene vicleucel) in newly diagnosed…

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CorDx Granted CE Mark for Two Monkeypox Diagnostic Tests

08/25/2022

Diagnostics enable the detection of the monkeypox virus in humans Excerpt from the Press Release: SAN DIEGO, Aug. 18, 2022 /PRNewswire/ — CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and medical devices, was recently granted a CE Mark certificate for two of the company’s monkeypox diagnostic tests. The CE Mark,…

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Valo Health Announces First Patient Dosed in the OPL-0401 Phase 2 study of an oral ROCK1/2 inhibitor for the Treatment of Non-Proliferative Diabetic Retinopathy

08/23/2022

Excerpt from the Press Release: Valo’s Opal Computational Platform™ being used to select a patient subset within non-proliferative diabetic retinopathy patients at high risk of progressing toward vision-threatening disease BOSTON, Aug. 18, 2022 /PRNewswire/ — Valo Health, Inc. (“Valo”), the technology company focused on transforming the drug discovery and development process using human-centric data and…

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Corcept Therapeutics Initiates ROSELLA – A Pivotal Phase 3 Trial in Recurrent, Platinum-Resistant Ovarian Cancer

07/04/2022

Phase 2 trial showed that relacorilant plus nab-paclitaxel improved progression-free survival, duration of response and overall survival without an increased side effect burden compared to nab-paclitaxel alone Excerpt from the Press Release: MENLO PARK, Calif., June 29, 2022 (GLOBE NEWSWIRE) — Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development…

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Research suggests specialized brain imaging can unveil mysteries of Alzheimer’s disease, other disorders

06/21/2022

Excerpt from the Press Release: Alzheimer’s disease is the most common form of dementia, one of the major causes of dependency and disability in older adults. Though advances have been made in understanding the harrowing brain disease, diagnostic tests are currently limited and there are no treatments. Now, a uOttawa Faculty of Medicine assistant professor and a…

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OptraSCAN’s Artificial Intelligence-Equipped Digital Pathology Scanner OS-SiA Granted U.S Patent for Scanning, Indexing and Analyzing of the Tissue Area at the Same Time

06/07/2022

Excerpt from the Press Release: SAN JOSE, Calif., May 24, 2022 /PRNewswire/ — OptraSCAN®, the leading end-to-end digital pathology solution provider, announced its digital pathology scanner OS-SiA has been granted US patent – No 2020/0334814 A1 by the United States Patent and Trademark Office. OS-SiA has inbuilt intelligence to scan, index and analyze pathological samples…

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Nexus Medical Labs Receives FDA Emergency Use Authorization for SARS-CoV-2 Test Using the RHINOstic™ Automated Nasal Swab from Rhinostics

06/03/2022

Automated and Easily Scalable Swab-Based Workflow Supports Increased Sample Throughput and Processing Consistency Excerpt from the Press Release: WALTHAM, Mass. & WATERTOWN, Mass.–(BUSINESS WIRE)–Rhinostics Inc. and Nexus Medical Labs recently received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a molecular SARS-CoV-2 test enabling unsupervised self-collection. The test, based on…

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Qualigen Therapeutics’ Pan-RAS Inhibitor Featured in Two Abstracts at American Society for Clinical Oncology (ASCO) 2022 Annual Meeting

06/02/2022

Abstracts Highlight In Vitro and In Vivo Activity of Qualigen’s Pan-RAS inhibitor in (1) Pancreatic Cancer, and (2) Malignant Peripheral Nerve Sheath Tumors Excerpt from the Press Release: CARLSBAD, Calif., May 26, 2022 (GLOBE NEWSWIRE) — Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers…

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