An early user of a new Mycoplasma genitalium and antibiotic resistance test from SpeeDx that uses the Xpert cartridge shared some initial validation data.
The firm said that its cell-free DNA assay has shown a high positive predictive value in preliminary clinical studies involving stage IV colorectal cancer patients.
The test, which searches for fragments of DNA 200 basepairs or longer that are characteristic of diseased mucosa, may eventually compete with diagnostics like Exact Sciences' Cologuard.
The firm said that the assay uses vaginal or rectal swabs to identify Group B Streptococcus DNA in about an hour. It has filed for 510(k) clearance with the US FDA.
Qiagen's partnership and merger agreement with NeuMoDx may help it compete with high-volume molecular testing vendors such as Abbott, Hologic, and Roche.
