Agendia, Inc. today announced that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint® FFPE Microarray, BluePrint® FFPE Microarray, and MammaPrint and BluePrint NGS Kit. These products are classified as Class C under this regulation. This certification recognizes Agendia’s strict adherence to rigorous quality and safety standards and ensures the tests’ reliability and effectiveness in clinical settings across the EU.

The US Food and Drug Administration announced on Friday that it has granted de novo marketing authorization to an over-the-counter test for syphilis antibodies manufactured by NowDiagnostics.

Agilent Technologies Inc., (NYSE: A) today announced the release of its new Agilent J&W 5Q GC/MS Columns, representing a major advance in gas chromatography/mass spectrometry (GC/MS) column technology. Agilent has a 50-year history of innovation in gas chromatography, continually setting the standard for GC column performance. The new Agilent J&W 5Q GC/MS columns combine Agilent’s industry-recognized ultra-inert performance and ultra-low-bleed technology, delivering unmatched performance and durability for the most demanding applications.

Micronutrients are essential vitamins and minerals that are vital for well-being and disease prevention, but deficiencies can commonly be caused by food allergies and dietary restrictions, certain prescription medications, or chronic health conditions. At least one in three Americans are at risk of nutrient deficiencies1. Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced the availability of 13 blood tests designed to evaluate micronutrient deficiencies, helping people identify if they are lacking certain vitamins and minerals needed by the body to maintain optimal health. These panels are now available for consumer purchase exclusively at questhealth.com.

The US Food and Drug Administration recently granted Emergency Use Authorization for an over-the-counter combination COVID-19 and influenza test developed by Acon Laboratories.

By 2030, a diabetes prevention and treatment system will enable over 60% of residents aged 18 and above to be aware of the disease. By then, the coverage rate of standardized management services for type 2 diabetes patients at the primary level will exceed 70%, according to the documents released by multiple departments including the National Health Commission (NHC).

Eli Lilly has opened a new R&D facility in the Boston Seaport district with the aim of advancing the firm's RNA and DNA-based therapies, as well as discovering new drug targets and developing new medicines.

Illumina, Inc. (NASDAQ: ILMN) today is hosting a Strategy Update for investors to present its strategy and three-year financial outlook that features accelerating revenue growth and significant margin expansion.

In terms of the market share, the biochemical industry in the international market is highly concentrated. The “four giants” (Roche, Beckman, Siemens, and Abbott) have occupied more than 80% of the market share in the international market by virtue of their first-mover advantage. Domestically, many companies enter the IVD field due to low market entry barrier and high gross profit margins of biochemical reagents, so there are numerous enterprises.

Quanterix on Thursday reported an 11 percent rise in second quarter 2024 revenues.

A new study conducted by Quest Diagnostics in collaboration with the University of Alabama has revealed significant gaps in the testing and treatment of sexually transmitted infections (STIs) among pregnant women in the United States.

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

Paige, a global leader in clinical AI applications for cancer, in collaboration with Microsoft, has unveiled the second generation of Virchow, its million-slide foundation model for cancer. As additions to Paige’s suite of foundation models, the world’s largest and most advanced AI models in clinical pathology, Virchow2 and Virchow2G offer a deeper understanding of cells and tissue, aiming to redefine cancer diagnosis and treatment.

Missouri-based diagnostic provider C2N has struck a deal with diagnostic services provider Unilabs to expand access to its Precivity portfolio of Alzheimer’s blood tests in over 75 countries.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today reported its financial results for the second quarter ended June 30, 2024.