CE mark

The test leverages a novel cancer biomarker that may improve the accuracy and sensitivity of noninvasive bladder cancer testing.

The firm's Inify Prostate Screening product presorts slides in a worst-first order, allowing pathologists to work immediately on the most relevant areas.

The algorithm provides automated assessments of objective and reproducible scanned slide images that can help with diagnosis and targeted treatment options.

The Rida Gene SARS-CoV-2 test runs on the Roche LightCycler 480II and is intended for use in hospital, reference, private, and state laboratories.

The test has 100 percent sensitivity and almost 100 percent specificity, and the company has ramped its manufacturing capacity to deliver 30 million tests per month.

The test has been developed to run on Illumina's NextSeq 550Dx next-generation sequencing platform and will be prepared for commercial launch in Europe.

The PCR test detects HIV-1 RNA on the NeuMoDx 96/288 Molecular Systems and joins the company's other bloodborne viral tests for hepatitis B and C.

The disease occurs when cytomegalovirus infection is passed from a mother to an unborn child and can lead to severe and potentially fatal outcomes.

Along with predicting preeclampsia, the Delfia Xpress sFlt-1 kit can be used to help diagnose the condition in the second and third trimesters of pregnancy.

Promega will seek to expand use of the assay in Europe while it works through regulatory review of the test for companion diagnostic use in the US and Asia.