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.

Seegene Inc. (KQ096530), a leading South Korean company providing a total solution for PCR molecular diagnostics, announced today an extension of its strategic partnership with Springer Nature, a trusted provider to the global scientific community and the publisher of the prestigious scientific journal, Nature.

Hitachi High-Tech Corporation ("Hitachi High-Tech") and Gencurix, Inc. ("Gencurix") have entered a strategic partnership (the Partnership) in the field of cancer molecular diagnostics.

The US Attorney's Office for the Northern District of California said earlier this week that cancer testing company Guardant Health has agreed to settle allegations that it knowingly violated the False Claims Act and regulations of the Defense Health Agency.

The Association for Molecular Pathology on Thursday published a new set of evidence-based recommendations for the analytical validation and reporting of tumor mutational burden (TMB) testing.

Point-of-care diagnostic firm Cue Health is laying off all of its employees and shuttering its operations.