On December 24, Shanghai Government unveiled the "Work Plan for Developing Medical Artificial Intelligence (2025–2027)" to advance the deep integration of artificial intelligence (AI) with clinical medicine and promote the application of vertical large models in diagnostic support for testing and inspection.

Pertussis is a highly contagious acute respiratory disease that can last for several months and often causes epidemics.

Agilent Technologies Inc. (NYSE: A) today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for PD-L1 IHC 28-8 pharmDx (Code SK005). This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR) 1. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.

In 2019, there were about ten million TB patients worldwide and 1.5 million deaths, and China ranks third in the world with 895,000 new cases of TB each year, most of which are pulmonary TB. The diagnosis of pulmonary TB is based on pathogen detection. Molecular diagnostic is one of the methods of pathogen detection, and the target of the test is the Mycobacterium tuberculosis complex (MTBC). Most of the molecular diagnostic reagents for tuberculosis are based on fluorescent PCR technology.

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, and MyOme, a leading clinical whole genome analysis and polygenic risk modeling company, today announced the launch of an integrated polygenic risk score (iPRS) for personalized breast cancer risk assessment. iPRS, which reports 5-year and lifetime breast cancer risk, offers individuals who receive a negative test result with Natera’s Empower hereditary cancer test the opportunity for further risk assessment using MyOme’s integrated polygenic risk score.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® FILMARRAY® Tropical Fever (TF) Panel has received U.S. Food and Drug Administration (FDA) Special 510(k) clearance. This innovative polymerase-chain reaction (PCR) testing solution offers fast and accurate pathogen identification in patients with unexplained fever, helping to optimize treatment overall.

Latent tuberculosis infection (LTBI) is defined as a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens with no evidence of clinically manifested active TB.

Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that its market-leading Decipher Prostate Genomic Classifier is the only gene expression test to be included in version 1 of the 2025 NCCN* Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as part of the updated “Advanced Tools” table located in the Principles of Risk Stratification and Biomarkers section (PROS-H) .

Copan Diagnostics, a leader in microbiology laboratory innovations, is proud to announce that UriSponge®, a urine collection and transport device which uses a new formulation of advanced preservatives to ensure specimen stability for culture, has received clearance from the U.S. Food and Drug Administration (FDA). The solution offers clinical laboratories and healthcare providers a user-friendly, reliable, and cost-effective way to improve urine specimen collection, preservation, and transport.

The company says the new facility will be the “modern diagnostics production center in Europe.”

The World Health Organization (WHO) has granted prequalification to the molecular diagnostic test for tuberculosis (TB) called Xpert® MTB/RIF Ultra. It is the first test for TB diagnosis and antibiotic susceptibility testing that meets WHO's prequalification standards.

LGC on Wednesday said it has acquired DiaMex, a German manufacturer of third-party serology and molecular quality controls for clinical laboratories and blood banks, for an undisclosed amount.