T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel. The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S. market.

Danaher on Tuesday announced that it will provide Cepheid's tuberculosis test to the Global Fund to Fight AIDS, TB, and Malaria, as well as to less-developed countries eligible for Cepheid's Global Access Program, at cost.

China Association of In Vitro Diagnostics (CAIVD) and In Vitro Diagnostics Society of China Association for Medical Devices Industry jointly compiled this report.

An expert panel led by researchers at the Ohio State University Wrexner Medical Center and College of Medicine has published a set of evidence-based guidelines for genetic testing and counseling for people with amyotrophic lateral sclerosis (ALS).

Agilent Technologies Inc. (NYSE: A) recently signed a Research Collaboration Agreement (RCA) with the National Cancer Centre Singapore (NCCS) outlining their collaboration to accelerate translational cancer research on the genomic landscape of Asian-prevalent cancers over the next two years.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Experts have raised concerns about Quest Diagnostics’ $399 consumer-initiated Alzheimer’s disease test, telling 360Dx that it is unclear whether the product is accurate enough to support its use.

Diagnostic healthcare company New Day Diagnostics has announced the approval of an agreement to acquire Epigenomics to provide accessible and innovative diagnostic solutions.

Natera on Thursday announced a new study within the Phase II I-SPY 2 trial that will evaluate the ability of its Signatera minimal residual disease test to monitor breast cancer patients' response to neoadjuvant therapy.

MGI Tech said on Thursday that it has signed a memorandum of understanding with South Korean life science tools distributor Bio-Medical Science (BMS) to bring its next-generation sequencing products to South Korea.

Recognizing the long-term needs of the biopharma industry in China and Asia-Pacific, global life sciences leader Cytiva has opened its expanded Shanghai facility. The facility is 11 000 m2, fully operational, and designed to help advance and accelerate the development of novel therapeutics. Customers have access to a wide range of technologies, solutions, and services, including Cytiva’s Fast Trak training center, a Center of Excellence for single-use technologies, and a new automation and digital lab. It is also home to China’s online experience center, customized bioprocess solutions labs and compliance validation labs.

Devyser and Thermo Fisher Scientific have entered into a collaboration agreement to promote laboratory services. The goal is to partner with pharmaceutical companies to support their development projects utilising Devyser’s unique assays in its CLIA-certified laboratory.

For those international medical device companies aiming to localize in China, what exactly does "manufactured within China" mean? To what extent does "localization" qualify as "manufactured within China"?

Astek Diagnostics and Key Technologies announced on Tuesday that they have partnered to develop a benchtop analyzer that will be used to diagnose urinary tract infections.

Agilent Technologies, Inc. (NYSE: A) and Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, today announced they have entered into a definitive agreement for the sale of Resolution Bioscience to Exact Sciences. Financial terms of the agreement were not disclosed and are not material to either party.