With the development of artificial intelligence technology, it plays an important role in laboratory medicine, especially in the automatic identification of cell morphology. The new generation of AI technology shows the characteristics of deep learning, autonomous learning, human-machine collaboration, and so on.
Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.
Augurex Life Sciences Corp., a leader in autoimmune biomarker-based diagnostics, today announced that it has formed a nonexclusive agreement with Quest Diagnostics, a leading provider of diagnostic information services, under which Quest will validate and offer a lab-developed test based on the Augurex 14-3-3η (eta) biomarker in the United States.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE Mark for its VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay. This is the first immunohistochemistry (IHC) companion diagnostic test to be made widely available in Europe to aid in identifying epithelial ovarian cancer (EOC) patients who may be eligible for targeted treatment with ELAHERE® (mirvetuximab soravtansine). ELAHERE is a first-in-class antibody-drug conjugate (ADC) therapy developed by AbbVie for the treatment of FRɑ-positive platinum-resistant ovarian cancer.
PAVmed Inc. (NASDAQ: PAVM, PAVMZ) ("PAVmed" or the "Company"), a diversified commercial-stage medical technology company, operating in the medical device, diagnostics, and digital health sectors, today provided a business update for the Company and its subsidiaries, Lucid Diagnostics Inc. (NASDAQ: LUCD) ("Lucid") and Veris Health Inc. ("Veris"), and presented financial results for the Company for the three months ended September 30, 2024.
SEKISUI Diagnostics’ microbial CDMO business announces it has completed construction of its £15.7 million ($20.7 million) cGMP capacity expansion at its UK site for clinical-grade drug substance manufacturing. Following appropriate licensure, this expansion will enable manufacturing capabilities for common drug types including enzymes, proteins and antibody fragment therapies, as well as plasmids and enzymes for cutting-edge gene therapy manufacture.
Caris Life Sciences® (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, today announced the U.S. Food and Drug Administration (FDA) has approved MI Cancer Seek™ for use as a companion diagnostic (CDx) to identify cancer patients who may benefit from treatment with targeted therapies. The assay includes one pan-cancer and five tumor-specific indications for numerous FDA-approved therapies. MI Cancer Seek is the first and only simultaneous Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS)-based assay with FDA-approved CDx indications for molecular profiling of solid tumors. MI Cancer Seek is available for adults and pediatric patients, ages 1-22.
Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), today provided a business update for the Company and presented financial results for the three months ended September 30, 2024.
Chinese authorities recently released revised rules on foreign investors' strategic investment in listed companies in a move to encourage foreign investors to make long-term and value investments in the country.
Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced a collaborative agreement with Thermo Fisher Scientific Inc. (NYSE: TMO), through its subsidiary Life Technologies Corporation (“Thermo Fisher”), a world leader in supplying life sciences solutions and services.
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today reported its financial results for the third quarter ended September 30, 2024.
The following innovative products have obtained the registration certificate of regulatory authorities for the first time in the industry based on the technology platform, and are open to the whole market as the benchmark. Only some representative products are listed.
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