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FDA clearance

The company is focusing on hematological malignancies and looking to partner with pharmaceutical companies for companion diagnostics.

The trichomonas assay is Quidel's sixth assay running on the AmpliVue handheld molecular diagnostic device that has been cleared by the FDA. 

Available in March, the PCR-based FilmArray 2.0 platform has higher throughput and takes up a smaller footprint.

The test uses the company's TOCE primer technology for multiplexed real-time PCR and is the first product Seegene has taken through the FDA.

The new clearance allows the use of the Xpert MTB/RIF test, in conjunction with other clinical or laboratory data, to remove patients from respiratory isolation.

The FDA conditionally approved the microarray-based gene expression test for use as entry criteria for a clinical trial for an investigational new drug for multiple myeloma. 

Margaret Hamburg

"It's one thing to have one diagnostic for one disease in the old world, but in the modern era that can't be the framework that we use," the FDA Commissioner said. 

The test runs on Roche's cobas 4800 system and is cleared for the early, simultaneous detection of MRSA and SA directly from nasal specimens. 

The firm also announced that it had placed more than 250 new QIAsymphony molecular diagnostics systems in 2014, surpassing its goal.

A preliminary discussion paper, posted on the FDA's website last month, outlines possible ways the agency might regulate NGS tests in the future.


23andMe and Airbnb have partnered to offer "heritage travel," according to Venture Beat.

China may include regulations protecting genes and embryos in its update of its civil code, Nature News reports.

In Nature this week: exome sequence analysis of individuals with type 2 diabetes, genomic prediction of maize yield across environments, and more.

NPR reports on efforts to engineer bacteriophages to destroy antibiotic-resistance bacteria.