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real-time PCR

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 kit, which was launched today, leverages real-time RT-PCR technology to detect and quantify hepatitis C virus-specific RNA with genotypes 1 to 6.

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 Resistance GC assay will allow doctors to treat up to 70 percent of infected patients with a single dose of ciprofloxacin.

The CDx would guide use of Novartis' BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women with HR+/HER2- breast cancer.

Genomic Health will have exclusive rights to develop and sell its Oncotype DX Genomic Prostate Score test on Biocartis' Idylla platform.

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.

The firm's molecular assay directly detects varicella-zoster virus DNA from a patient's cerebrospinal fluid and provides results in about one hour.

Qiagen's partnership and merger agreement with NeuMoDx may help it compete with high-volume molecular testing vendors such as Abbott, Hologic, and Roche.

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