CE mark

The solutions are solutions for both clinical chemistry and immunoassay platforms and are meant to help labs run tests faster on less equipment and automate manual tasks.  

The test is the first near-patient assay for M. genitalium, and can also guide treatment by detecting antibacterial resistance markers.

The firm said that its rapid point-of-care test enables immediate drug adjustments by measuring levels of clozapine, an antipsychotic drug, in a finger prick of blood.

The German firm said that IB10 Sphingotec DPP3 is the first CE-IVD-marked point-of-care biomarker test that can quantify DPP3 blood plasma levels.

The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1. 

The SuperExtract 32 with the SuperExtract Viral Mag NA Purification kit provides high-quality purification of hepatitis and HIV viral nucleic acid.

The updated test now includes additional susceptibility testing and clinical interpretive breakpoints that are compliant with 2019 European guidance.

NeuMoDx's tests are designed for central laboratory use and run on the company's fully automated NeuMoDx 96 or 288 real-time PCR systems.

The company said it got CE marking for use of its Vitros NT-proBNP II immunodiagnostic assay to diagnose and assess heart failure and enable risk stratification.