News & Updates

Roche expands the COVID-19 PCR test portfolio to the new cobas 5800 System in countries accepting the CE Mark

03/04/2022

– Roche continues to increase access to accurate, timely and reliable diagnostics in the fight against COVID-19 by expanding the COVID-19 PCR portfolio on the cobas 5800 System – These tests are for the qualitative detection of SARS-CoV-2 and the qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus – As…

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AI-Powered Algorithm Gets FDA 501(k) Clearance for Detection of Subarachnoid Hemorrhages

03/04/2022

A recent study found that Viz ANEURYSM had a 94 percent accuracy rate of diagnosing subarachnoid hemorrhages on computed tomography angiography (CTA). Excerpt from the Press Release: Subarachnoid hemorrhages reportedly affect nearly 30,000 Americans each year and have a 40 percent mortality rate. However, Viz ANEURYSM, a new artificial intelligence (AI)-powered algorithm, may improve the…

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Biocept Presentation at Molecular Medicine Tri-Con Meeting Highlights Potential of CNSide™ Assay to Support Development of Targeted Therapies for Metastatic Brain Cancer

03/04/2022

Ability to serially monitor treatment response, identify key biomarkers and customize assay aids clinical research efforts to improve treatment for metastatic cancers involving brain and spinal cord Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Feb. 22, 2022– Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, highlighted the ability of its CNSide™ cerebrospinal…

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Vaxcyte Doses First Participants in Phase 1/2 Clinical Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults

03/03/2022

— Company Expects to Announce Topline Results from the Phase 1/2 Study by the End of 2022 — — Proof-of-Concept Study Will Evaluate the Safety, Tolerability and Immunogenicity of VAX-24 — — VAX-24 is a 24-Valent Pneumococcal Conjugate Vaccine Designed to Deliver Broad-Spectrum Protection — Excerpt from the Press Release: SAN CARLOS, Calif., Feb. 23, 2022…

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Maze Therapeutics Announces Publication in Nature Describing a Novel Mechanism Linking Well-Established Genetic Drivers of ALS and FTD

03/03/2022

Findings Highlight Applicability of Maze’s Compass Platform to Identify and Provide Insight into Disease-Causing Genetic Variants to Treat Patients in Need Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Maze Therapeutics, a company translating genetic insights into new precision medicines for patients, today announced the publication in Natureof new findings describing a connection between genetic…

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ChromaCode’s Emergency Use Authorization (EUA) Expanded by FDA for High-Throughput HDPCR™ SARS-CoV-2 Real-Time PCR Assay

03/03/2022

Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–ChromaCode, Inc., a company redefining molecular testing through data science, announced today that the U.S. Food and Drug Administration has expanded the Emergency Use Authorization of ChromaCode’s HDPCR SARS-CoV-2 Assay to include several new qPCR instruments and use of 384-well plates, which has the potential to more than…

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Published Study Details Proof-of-Concept for COVID-19 Detection via Saliva Screening

03/02/2022

Methodology developed by QIMR Berghofer researchers utilizing the Agilent Cary 630 FTIR Spectrometer Excerpt from the Press Release: Agilent Technologies Inc. (NYSE: A) announced today that researchers from the QIMR Berghofer Medical Research Institute in Brisbane, Australia, collaborated with Agilent experts on a proof-of-concept FTIR-based saliva COVID-19 testing workflow using the Agilent Cary 630 FTIR Spectrometer. The study…

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Naveris’ Head and Neck Cancer Recurrence Detection Study Selected for Presentation at ASTRO 2022 Plenary Session

03/02/2022

Excerpt from the Press Release: NATICK, Mass.–(BUSINESS WIRE)–Naveris, Inc., a leader in molecular diagnostics for viral cancers, today announced the presentation of significant new data at the plenary session of the ASTRO 2022 Multidisciplinary Head and Neck Cancers Symposium supporting the clinical value of its flagship diagnostic test, NavDx®. In a real-world analysis of 1,076…

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Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma

03/02/2022

Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma If approved by the European Medicines Agency, KIMMTRAK will be the first and only treatment option approved in Europe to treat patients with unresectable or metastatic uveal melanoma KIMMTRAK demonstrated statistically and clinically meaningful overall survival (OS) benefit, hazard ratio of 0.51, with median OS of almost 22 months Excerpt from the…

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Merlin Test reduces unnecessary surgeries and associated complications for melanoma patients

03/01/2022

Excerpt from the Press Release: ROTTERDAM, Netherlands and SAN DIEGO, Feb. 24, 2022 /PRNewswire/ — Today, SkylineDx announced that their Merlin Test for melanoma patients would have been able to reduce over 59% of surgery-related complications by means of deselecting patients for surgery [2]. The commercially available Merlin Test identifies melanoma patients that can safely forgo a sentinel lymph node…

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