September 15, 2021 Acad, Gov/Utilities Chromatography Clinical Research/Diagn. Lab Top-10 Licensing, IP, and Legal Life Science Tools PAI Top-10

FDA Approves Tissue-Based NGS Companion Diagnostic for Takeda's Targeted Therapy for NSCLC Patients with EGFR Exon20 Insertion Mutations

FDA Approves Tissue-Based NGS Companion Diagnostic for Takeda’s Targeted Therapy for NSCLC Patients with EGFR Exon20 Insertion Mutations Oncomine Dx Target Test now approved as CDx for five targeted NSCLC therapies in the U.S. CARLSBAD, Calif., Sept. 15, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher... Read more

September 14, 2021 Clinical Research/Diagn. Life Science Tools M&A, Partnerships

Mesa Labs Announces Agreement to Acquire Agena Bioscience, Inc.

09/14/2021 LAKEWOOD, Colo., Sept. 14, 2021 (GLOBE NEWSWIRE) — Mesa Laboratories, Inc. (NASDAQ:MLAB) (“we”, “us”, “our”, “Mesa” or the “Company”), a global leader in the design and manufacturing of critical quality control solutions for the pharmaceutical, healthcare, and medical device industries, announced today that it has entered into a definitive agreement to acquire Agena Bioscience,... Read more

September 13, 2021 Clinical Research/Diagn. Licensing, IP, and Legal Liq. Handling & Robotics

Quanterix Receives Label Expansion On Emergency Use Authorization For COVID Antigen Test

Simoa SARS-CoV-2 N Protein Antigen Test is first antigen test validated to detect all Variants of Concern currently designated by CDC, including Delta variant, and first authorized for use in saliva samples EUA label expansion demonstrates additional evidence showing potential for Simoa technology across range of clinical tests, including less-invasive testing BILLERICA, Mass., September 13,... Read more

September 10, 2021 Clinical Research/Diagn. Lab Top-10 PR/Corporate

Oncomine Dx Target Test Receives MHLW Approval as a Companion Diagnostic for Eli Lilly's RET-Inhibitor in Non-Small Cell Lung Cancer in Japan

Oncomine Dx Target Test Receives MHLW Approval as a Companion Diagnostic for Eli Lilly’s RET-Inhibitor in Non-Small Cell Lung Cancer in Japan CARLSBAD, Calif., Sept. 10, 2021 /PRNewswire/ — Thermo Fisher Scientific today announced the Japan Ministry of Health, Labour and Welfare (MHLW), Japan’s regulatory agency, has granted approval for the Oncomine Dx Target Test as... Read more

September 8, 2021 Clinical Research/Diagn. Life Science Tools M&A, Partnerships

Bio-Techne and Carterra Initiate a Clinical Research Collaboration for COVID-19 Variant Analysis

SEPTEMBER 08, 2021 Companies bring together cutting-edge technologies and expertise to advance the world’s understanding of COVID-19 variants’ mechanism of action MINNEAPOLIS and SALT LAKE CITY, Sept. 8, 2021 /PRNewswire/ — Bio-Techne, a leading supplier of high-quality and innovative tools for life science research, therapeutic manufacturing and clinical diagnostics and Carterra Inc., the world leader in... Read more

September 7, 2021 Clinical Research/Diagn. M&A, Partnerships

Illumina Partners with Merck to Develop and Commercialize Companion Diagnostic and Research Tests for Use in Identifying Specific Cancer Mutations

Sep 7, 2021 SAN DIEGO, Sept. 7, 2021 /PRNewswire/ — Illumina, Inc. (NASDAQ: ILMN) and Merck (known as MSD outside the United States and Canada) today announced a partnership to develop and commercialize tests that identify genetic mutations used in the assessment of homologous recombination deficiency (HRD). Patients whose tumors are HRD-positive may be eligible for... Read more

September 7, 2021 Clinical Research/Diagn. Life Science Tools M&A, Partnerships

Illumina Acquires GRAIL to Accelerate Patient Access to Life-Saving Multi-Cancer Early-Detection Test

Sep 7, 2021 SAN DIEGO, Sept. 7, 2021 /PRNewswire/ — Illumina, Inc. (NASDAQ: ILMN) and Merck (known as MSD outside the United States and Canada) today announced a partnership to develop and commercialize tests that identify genetic mutations used in the assessment of homologous recombination deficiency (HRD). Patients whose tumors are HRD-positive may be eligible for... Read more

September 1, 2021 Clinical Research/Diagn. Lab Top-10 Life Science Tools

Thermo Fisher Scientific and AstraZeneca to Co-Develop NGS-based Companion Diagnostics

Thermo Fisher Scientific and AstraZeneca to Co-Develop NGS-based Companion Diagnostics CARLSBAD, Calif., Sept. 1, 2021 /PRNewswire/ — Thermo Fisher Scientific’s clinical sequencing business and AstraZeneca today announced they will co-develop next-generation sequencing (NGS)-based companion diagnostics (CDx) to support AstraZeneca’s expanding portfolio of targeted therapies. The companies will collaborate under a multiyear, global agreement. “As the... Read more

August 25, 2021 Acad, Gov/Utilities Atomic Spectroscopy Clinical Research/Diagn. Lab Top-10 Life Science Tools

FDA Approves NGS-Based Companion Diagnostic for Previously Treated IDH1-Mutated Cholangiocarcinoma

FDA Approves NGS-Based Companion Diagnostic for Previously Treated IDH1-Mutated Cholangiocarcinoma CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for TIBSOVO CARLSBAD, Calif., Aug. 25, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted pre-market approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to... Read more

August 18, 2021 Acad, Gov/Utilities Bio/Pharma/CRO Clinical Research/Diagn. PAI Top-10 PR/Corporate

Roche receives FDA approval for first companion diagnostic to identify dMMR solid tumour patients eligible for anti-PD-1 immunotherapy

Cancer is the second leading cause of death worldwide, with nearly 10 million deaths annually.1, 2 In the U.S., approximately 1.9 million new cancer cases are expected to be diagnosed in 2021.1 Based on cancer biomarkers, the first-of-its-kind VENTANA MMR RxDx Panel helps determine which solid tumour patients may benefit from GSK immunotherapy. Roche/GSK collaboration... Read more