Clinical Validation
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| Healthcare Topics | COVID-19, Biotech, Infectious Disease, Diagnostic Tests, Digital Health, Food and Drug Administration, Cancer Diagnostics |
| Companies | Biocept, Celgene, Novartis, AliveCor, Johnson & Johnson, Merck, Pfizer |
| Health Systems | Mayo Clinic, Harvard Medical School, MD Anderson Cancer Center |
| Capital Firms | Khosla Ventures |
| People | Amit Kumar, Bill Newell, Ripudaman Singh, Derek Maetzold, Eric Topol, Kuldeep Singh Rajput, Michael Nall |
| Locations | State of Maryland, New York, New York, York, Pennsylvania, State of California, State of New York |
Selected Headlines
| Date | Headline (link) | Source | Relevant Snippet |
|---|---|---|---|
| 4/3/2021 | Mayo Clinic, Thermo Fisher Scientific Collaborate to Benefit Patients | clpmag.com | Company News 0 Mayo Clinic and Thermo Fisher Scientific, Waltham Mass, have joined forces to bring innovative solutions to patients by accelerating clinical validation , and commercialization of selected next-generation sequencing (NGS), mass spectrometry, and immunology diagnostic tools. The Advanced Diagnostics Laboratory in One Discovery Square, which is part of the Destination Medical Center initiative, will be the home for this collaboration.“By pairing cutting-edge, innovative technologies with world ... |
| 3/29/2021 | Analysis system for breast cancer diagnosis solves ‘blackbox algorithm’ problem | MobiHealthNews | ... time, morphological, molecular and histological data are integrated in a single analysis.The results of the research have now been published in Nature Machine Intelligence and the researchers are now seeking certification and further clinical validation s - including tests in tumour routine diagnostics.WHY IT MATTERSMachine learning algorithms that are not transparent about to how they have come to a decision have been dubbed ‘blackbox’ algorithms .It can be ... |
| 3/26/2021 | Mayo Clinic, Thermo Fisher Scientific collaborate to benefit patients | rdworldonline.com | March 26, 2021By Suzanne FergusonMayo Clinic and Thermo Fisher Scientific have joined forces to bring innovative solutions to patients by accelerating clinical validation , and commercialization of selected next-generation sequencing (NGS), mass spectrometry and immunology diagnostic tools. The Advanced Diagnostics Laboratory in One Discovery Square, which is part of the Destination Medical Center initiative , will be the home for this collaboration."By pairing cutting-edge, innovative technologies with ... |
| 3/25/2021 | Mayo Clinic, Thermo Fisher Scientific collaborate to benefit patients | mayocliniclabs.com | Mayo Clinic, Thermo Fisher Scientific collaborate to benefit patientsMarch 25, 2021ROCHESTER, Minn. ― Mayo Clinic and Thermo Fisher Scientific have joined forces to bring innovative solutions to patients by accelerating clinical validation and commercialization of selected next-generation sequencing (NGS), mass spectrometry and immunology diagnostic tools. The Advanced Diagnostics Laboratory in One Discovery Square, which is part of the Destination Medical Center initiative , will be the home for ... |
| 3/23/2021 | Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint | karger.com | ... a new digital measure: asking the right question, optimized approaches to evaluating new measures, and whether and how to pursue qualification or acceptance. Building on the V3 framework for establishing verification and analytical and clinical validation , we discuss strategic and practical considerations for collecting this evidence, illustrated with concrete examples of trailblazing digital measures in the field. © 2021 The Author(s) Published by S. Karger AG, Basel Key Points A ... |
| 3/20/2021 | Identification of MiR-93-5p Targeted Pathogenic Markers in Acute Myeloid Leukemia through Integrative Bioinformatics Analysis and Clinical Validation | hindawi.com | ... ping Hao, Rong Chen, Dai-qin Xiong, Nan Ding, Jian-hua Yang, Jian-hua Wang, Xuan-sheng Ding, "Identification of MiR-93-5p Targeted Pathogenic Markers in Acute Myeloid Leukemia through Integrative Bioinformatics Analysis and Clinical Validation", Journal of Oncology, vol. 2021, Article ID 5531736, 17 pages, 2021. https://doi.org/10.1155/2021/5531736 Identification of MiR-93-5p Targeted Pathogenic Markers in Acute Myeloid Leukemia through Integrative Bioinformatics Analysis and Clinical Validation Abstract Acute ... |
| 3/17/2021 | Alveo Technologies' be.well COVID-19 Test Wins XPRIZE Rapid Covid Testing Competition | Yahoo News | ... including Alveo, were selected out of a pool of 219 semifinalists, with an initial 700 teams signing up. These semifinalists then had two weeks to send their testing kits and protocols to laboratories for clinical validation . Alveo won $500,000 as one of the top five teams that is advancing to the final deployment phase where its technology will be matched to deployment sites to prepare and administer tests. Each team ... |
| 3/17/2021 | Alveo Technologies' be.well COVID-19 Test Wins XPRIZE Rapid Covid Testing Competition | Yahoo News | ... including Alveo, were selected out of a pool of 219 semifinalists, with an initial 700 teams signing up. These semifinalists then had two weeks to send their testing kits and protocols to laboratories for clinical validation . Alveo won $500,000 as one of the top five teams that is advancing to the final deployment phase where its technology will be matched to deployment sites to prepare and administer tests. Each team ... |
| 3/17/2021 | The Ridgway Record | ridgwayrecord.com | ... IgG/IgM Test (“NADAL Rapid Test”), a leading test exclusively distributed by teräcero in Canada.The NADAL Rapid Test is highly specific and sensitive, as demonstrated repeatedly by numerous internal or independent clinical validation studies, including some by leading Canadian public health laboratories. Recently published results in the Journal of Clinical Microbiology (1), where the NADAL Rapid Test was compared to 10 laboratory-based tests and 2 other ... |
| 3/17/2021 | Rubius Therapeutics: Promising Cancer Treatment Data De-Risks Pipeline | dailymagazine.news | ... an unconfirmed PR in another patient with metastatic uveal melanoma. Additionally, the disease stabilizedin six patients.H.C. Wainwright's Andrew Fein calls the data a "pipeline de-risking event.""The early RTX-240 data provides clinical validation for the RED PLATFORM, providing proof-of-concept and proof-of-mechanism for engineered RBCs (red blood cells) to have a future in supporting the human immune system in targeting certain disease states," the ... |
| 3/16/2021 | Intellia advances CRISPR/Cas9 delivery to treat sickle cell | FiercePharma | ... for in vivo genome editing. The study moves Intellia a step closer to its goal of systemically delivering CRISPR/Cas9 to treat diseases such as sickle cell.CRISPR Therapeutics and Vertex have provided early clinical validation of the use of ex vivo genome editing to treat sickle cell. However, Intellia sees downsides to the ex vivo approach, such as the complexity of its manufacturing process and toxicity of the conditioning ... |
| 3/15/2021 | Rubius Therapeutics surges 84% on encouraging results from early-stage testing of cancer treatment | Business Insider | ... ongoing phase 1/2 trial of RTX-240, the company's cellular therapy product candidate, there was a 54% reduction in target lesions in a patient with metastatic anal cancer.Rubius said the data collected "provide clinical validation " of its Red Platform red blood cells generation system, said Pablo Cagnoni, chief executive at Rubius, in a statement.With "encouraging" initial safety and preliminary efficacy data for RTX-240, he said the company ... |
| 3/12/2021 | Australian Medical Cannabis Company Relocates Headquarters, Leadership to Plymouth Meeting | montco.today | ... based and hemp-derived] product development, product launch and revenue generation,” Odumosu said.He added that Zelira has set apart them from competitors by focusing “on developing products that have some kind of clinical validation , whether it’s in the form of real-life clinical evidence or clinical trial results.”The new headquarters will be home to ten employees.Read more about Zelira Therapeutics at the Philadelphia Business ... |
| 3/12/2021 | GeneFirst Aims to Prove Clinical Feasibility for ATOM-Seq Colorectal Cancer Detection Test | genomeweb.com | NEW YORK – UK-based diagnostics firm GeneFirst is ramping up a clinical validation and feasibility study for a blood-based colorectal cancer detection assay using the firm's ATOM-seq technology, which could support its first clinical implementation.Led by University of Leeds professor Philip Quirke, the 36-month project received a supporting grant last August for £1.4 million ($1.9 million) from the UK's National Institute of Health Research ... |
| 3/11/2021 | InteRNA Technologies Awarded € 2.7M Clinical Innovation Credit from Dutch Government | Yahoo News | Further supporting the clinical validation of lead microRNA candidate INT-1B3 in solid tumors --InteRNA Technologies , a clinical-stage biotech company developing microRNA (miRNA)-based therapeutics with a focus on cancer, today announced that it was awarded a Clinical Innovation Credit of € 2.7 Million from the Dutch government. This award will support the clinical validation of the Company’s lead candidate, INT-1B3, for the treatment of solid tumors ... |
| 3/11/2021 | Boosted by Microsoft's tech, Adaptive Biotechnologies' new diagnostic test for COVID-19 gets FDA nod | FierceHealthcare | ... possible to read how T cells detect disease in the blood, and this is just the beginning of a pipeline of tests for many other indications.”The FDA's EUA was based on a clinical validation study showing that T-Detect COVID demonstrated a sensitivity of 97.1% from date of diagnosis using RT-PCR. Sensitivity is the ability of the test to correctly identify a positive case (true positive). T ... |
| 3/10/2021 | Subtle Medical Launches SubtleMR(TM) 2.0 to Expand Improved MRI Capabilities | salesandmarketingnetwork.com | ... and musculoskeletal regions of the body, and increase image sharpness for head MRI."We are excited about the results we've seen with SubtleMR," said Suzie Bash, MD, Neuroradiologist at RadNet. "In our multicenter, multireader clinical validation research, we reduced our image acquisition time by 60% and were able to restore excellent image quality which exceeded that of standard-of-care. As we have begun incorporating SubtleMR into our routine clinical ... |
| 3/10/2021 | Subtle Medical launches SubtleMR 2.0 to expand improved MR capabilities | dotmed.com | ... and musculoskeletal regions of the body, and increase image sharpness for head MRI."We are excited about the results we've seen with SubtleMR," said Suzie Bash, MD, Neuroradiologist at RadNet. "In our multicenter, multireader clinical validation research, we reduced our image acquisition time by 60% and were able to restore excellent image quality which exceeded that of standard-of-care. As we have begun incorporating SubtleMR into our routine clinical ... |
| 3/10/2021 | GUANGZHOU, China, March 10, 2021 (GLOBE NEWSWIRE) | wapakdailynews.com | ... typing test in Oct 2020. This places OncoCompass TM Target in a leading position for the multi-gene ctDNA NMPA 1 4-stage approval process, which comprises (i) analytical validation, (ii) typing test, (iii) clinical validation , and (iv) review and approval. Fourth Quarter 2020 Financial ResultsRevenues were RMB131.7 million (US$20.2 million) for the three months ended December 31, 2020, representing a 48.5% increase from RMB88.7 million for the ... |
| 3/9/2021 | Expert insights from collaborative and commercial microbiome research studies | news-medical.net | ... Ireland and Atlantia provides a powerful translational pipeline that ranges from the discovery of microbiome features that are medically relevant in specific conditions, the design of nutritional approaches to target these features, and the clinical validation of these approaches using disease-specific surrogate endpoints. First Topic: Food and Ingredient Development Opportunities for Microbiome ModulationHumankind faces a crisis of non-communicable chronic diseases that encompass pathologies such as obesity (and ... |