FDA clearance

The funding will be used to pay for clinical trials in the US that will be used as underlying evidence for FDA clearance of the test, the company said.

The PCR-based test can simultaneously detect for the Zika virus, all serotypes of the dengue virus, the chikungunya virus, the West Nile virus, and a host gene. 

The iC-System is based on on iCubate's amplicon-rescued multiplex PCR technology, which detects multiple pathogens simultaneously.

The US Food and Drug Administration yesterday granted emergency use authorization to Thermo Fisher Scientific's TaqPath Zika Virus Kit.

The new version of the mass spectrometry-based system adds 144 microbial species to its database and includes new tools for sample preparation.

NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.

The firm said that the RealTime CMV test is the only commercially available cytomegalovirus that can amplify two select regions of the CMV genome.

At the WIN Symposium, a Merck executive detailed how data from a basket study led to the first pan-cancer, biomarker-informed cancer drug. 

The kit was previously approved by FDA for use on Qiagen's Rotor-Gene Q real-time PCR platform, which is one component of the automated QiaSymphony platform.

The FDA approved the real-time PCR-based test for use on the Cobas 6800 and 8800 systems to assess the response of transplant patients to treatments. 

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While gene therapies may have high price tags, they could be cheaper than the cost of managing disease, according to MIT's Technology Review.

Researchers are looking for markers that indicate which cancer patients may respond to immunotherapies, the Associated Press writes.

In Nature this week: paternal age associated with de novo mutations in children, and more.

Nature News writes that researchers are still wrangling over the role of the p-value.