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The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument.
The firm said that it has completed clinical trials for the Group B Strep assay for the FDA and will start trials for the C. difficile test this month.
The test is the third in the firm's line of infectious disease assays, which also includes tests for meningococcus and Group B Strep.
The company said it expects a 1 percent increase in 2016 revenues, but noted that the results were adversely affected by certain competitive pressures in Q4, among other problems.
Nearly 8,000 patients participated in a screening study that used a PCR-based detection assay from Becton Dickinson, uncovering a 5 percent carrier rate.
A draft guidance issued by the US Food and Drug Administration regarding fecal microbiota transplants may affect how stool banks operate.
At the Personalized Medicine World Conference, researchers talked about how understanding the microbiome is leading to therapies aimed at keeping it healthy.
The company plans to add assays for Group B Streptococcus, Clostridium difficile, and norovirus in 2016 to complement its existing meningitis test.
Wells Fargo downgraded Cepheid from Outperform to Market Perform, citing the firm's "credibility and visibility" following a revised 2017 outlook.
The Quebec City, Canada-based firm will launch its point-of-care molecular platform with GBS and C. diff tests next year as CE-IVD products.
The editorial board of the Pittsburgh Post-Gazette says other lawmakers should take Florida's approach and provide additional protections against genetic discrimination.
The Hill reports 17 states and the District of Columbia are suing over a new policy that would strip international students of their visas if they only attend classes online.
Centers for Disease Control and Prevention employees call on the agency to label racism a public health crisis and examine its own policies, NPR reports.
In PNAS this week: genetic evidence for Inca resettlement, analysis of spermatogonial stem cell transcriptomes, and more.