Technology & Devices

FDA Issues Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit

Today, the U.S. Food and Drug Administration took another significant diagnostic action during the coronavirus outbreak (COVID-19). The FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit. “This action today shows our agency’s dedication to working around the clock to …

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Thermo Fisher Scientific Signs Agreement with Janssen to Co-Develop Companion Diagnostic for Cancer

CARLSBAD, Calif., March 12, 2020 /PRNewswire/ — Thermo Fisher Scientific announced today it has signed an agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to co-develop a companion diagnostic (CDx) in oncology. The CDx will support clinical trial enrollment globally. Under the agreement, …

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Roche Receives FDA Approval for CINtec PLUS Cytology Test to Aid Clinicians in Improving Cervical Cancer Prevention

Basel, 11 March 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of CINtec® PLUS Cytology as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus (HPV) using the cobas® 4800 HPV Test. This …

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Study Finds Potential of Whole Breast Ultrasound Tomography to Improve Breast Cancer Risk Assessment

NOVI, Mich.–(BUSINESS WIRE)–Delphinus Medical Technologies, Inc., the leader in advanced breast ultrasound technology, has announced that results of a study comparing the use of whole breast ultrasound tomography (UST) and mammography to assess breast cancer risk have been published in the Journal of Clinical Medicine. The study was conducted by researchers …

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Atomwise and Bridge Biotherapeutics Sign $1 Billion Deal to Unlock Blockbuster Potential in Inflammation

SAN FRANCISCO–(BUSINESS WIRE)–Atomwise, the leader in using artificial intelligence (AI) for small molecule discovery, and Bridge Biotherapeutics, a clinical stage biotech company, announced today a research collaboration to launch up to 13 small molecule programs across multiple therapeutic areas using structure-based AI technology for drug discovery. Under the agreement, Atomwise …

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Voluntis and Bristol-Myers Squibb to Co-Develop Digital Therapeutics for Oncology

NEW YORK & PARIS–(BUSINESS WIRE)–Regulatory News: Voluntis (Paris:VTX) (Euronext Paris, Ticker: VTX – ISIN: FR0004183960), a leader in digital therapeutics, and Bristol-Myers Squibb Company (NYSE:BMY) today announced a collaboration agreement to create and investigate digital therapeutic solutions that will support cancer patients. Leveraging Theraxium Oncology, Voluntis’ core platform for digital …

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First Prospective Study Shows +RNAinsight Identifies More Patients with Increased Risk for Hereditary Cancer Than DNA-Only Testing

ALISO VIEJO, Calif., Feb. 25, 2020 /PRNewswire/ — Ambry Genetics (Ambry), a leading clinical genetic testing lab, announced the publication of a study in Nature Partner Journal Precision Oncology finding that RNA genetic testing, conducted at the same time as DNA testing, identifies more genetic mutations that increase genetic cancer …

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FDA Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis of Fragile X Syndrome

The U.S. Food and Drug Administration today authorized marketing of the first test to detect a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability. The test is intended as an aid in diagnosing FXS and is to be …

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NantOmics and NantHealth Announce Results of AI Software Study Demonstrating the Ability to Identify Aggressive Subtypes of Breast Cancer from Digital Pathology Images

CULVER CITY, Calif.–(BUSINESS WIRE)–NantOmics, LLC, the leader in molecular analysis, and NantHealth, Inc. (NASDAQ: NH), a next-generation, evidence-based, personalized healthcare company, announced today the publication of a peer-reviewed study in Breast Cancer Research, a Springer Nature journal, on a novel AI technique in breast cancer. The study reports on a novel deep-learning system of digital pathology …

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Saama and Pfizer Partner to Transform Work of Clinical Data Managers and Monitors With AI

CAMPBELL, Calif.–(BUSINESS WIRE)–Saama Technologies, Inc., the number one AI clinical analytics platform company, announced today that it signed an agreement with Pfizer Inc. to develop and deploy an AI-powered analytics solution to reduce the challenges commonly experienced by clinical study data managers and monitors. Under this agreement, Saama’s award-winning Life Science Analytics …

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