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.

According to the statistics published on the website of the NMPA, in 2020, NMPA approved eight models, one is for fluorescent PCR data analysis, one is for chip data analysis, five are for sequencing data analysis, and one is for interpretation of tumor and genetic disease gene detection results.

In 2020, NMPA approved 18 types of class III molecular diagnostic instruments, and the provincial medical product administration approved 11 types of class II molecular diagnostic instruments, a total of 29.

Seegene Inc., a leading South Korean company providing a total solution for PCR molecular diagnostics, announced today the finalization of a partnership agreement with Werfen, a worldwide leader in specialized diagnostics, on the technology-sharing initiative. Under the agreement, Seegene and Werfen will set up a NewCo in Spain, Werfen-Seegene, upon the conclusion of mandatory government approvals anticipated by the first half of 2025.

The clinical application of molecular diagnostic technology is mainly in the form of detecting nucleic acid markers, including reagents and instruments, which are regulated by the National Medical Product Administration (hereinafter referred to as NMPA).

Diasorin (FTSE MIB: DIA) today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the LIAISON PLEX® Gram-Negative Blood Culture Assay, the second of the three molecular multiplexing panels for Blood Culture identification on the LIAISON PLEX®.

Molecular diagnostics uses human saliva, tissue, blood, feces, urine, and other samples to detect disease-related markers and provides experimental diagnostic results for medical professionals in disease prevention, screening, diagnosis, stratification, prognosis, and efficacy monitoring.

The US Food and Drug Administration said Tuesday that it plans to reclassify several types of qualitative and quantitative hepatitis B virus (HBV) tests as moderate risk Class II devices from their current classification as high-risk Class III devices.

LuminUltra, the global leader in applied molecular diagnostics, today announced the acquisition of the legionella testing business assets of Genomadix Inc, along with rights to develop and commercialize further assays and test methods in water, energy and food and beverage markets globally using the Genomadix Cube™ qPCR (quantitative polymerase chain reaction) Platform.

Seegene Inc., a leading provider of total solution for PCR molecular diagnostics based in South Korea, announced today that it will introduce a new type of research-use-only (RUO) PCR assay to address the spread of the mpox virus variant, Clade Ib, which is currently prevalent in Africa.