NMPA，Medical Device，Pharmaceutical

Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, announced updates to its agreement with Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies.

Tagomics Ltd., a pioneering biomarker discovery and diagnostics company, today announced it has entered into a strategic co-marketing agreement with Agilent Technologies, a leading tools provider in the genomics sector.

Alveo Technologies, Inc. (Alveo), a leader in decentralized molecular diagnostics with its proprietary IntelliSense™ molecular detection technology, today announced that it received an agreement issued by the United States Centers for Disease Control and Prevention (CDC) on a competitive basis to develop a rapid, molecular, point of need diagnostic to detect and differentiate between Influenza A + B, and A/H5 in humans.

Lab informatics firm Sapio Sciences said Monday that it has entered a comarketing agreement with Waters.

1.2 Portable Fluorescence PCR Cycler The miniaturization of fluorescent PCR instruments is also a trend. Small PCR cyclers are portable and realize mobile detection. The detection can be carried out on-site, or ..

Roche subsidiary Foundation Medicine said on Monday that its FoundationOne Liquid CDx assay has received approval from the US Food and Drug Administration for use as a companion diagnostic with Merck KGaA's Tepmetko (tepotinib) in patients with non-small cell lung cancer.

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.

Taking place 22-24 March at the Hangzhou Grand Convention & Exhibition Center, CACLP 2025—the 22nd China International In Vitro Diagnostic Expo—will make a significant impact, bringing a sharp focus to global in..

At the 7th China International Import Expo (CIIE), themed "New Era, Shared Future", representatives from 152 countries, regions, and organizations gathered for national and corporate exhibitions. On 8 November, Switze..

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.

Original from: Caris Life Sciences 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..

Original from: Lucid Diagnostics Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq:..