CE mark

Roche's Cobas TaqScreen DPX test; BlackBio's BlackLight Fungal ID kit.

The firm expects to obtain a CE Mark for the assay later this quarter, and plans to eventually submit the panel to the US Food and Drug Administration for 510(k) clearance.

The new platform, called Panther, is expected to help Gen-Probe capture market share in the area of molecular testing at mid- and low-volume clinical laboratories, clinics, and physicians' offices as it competes with platforms from companies such as Roche, Qiagen, Cepheid, and Becton Dickinson.

Epigenomics' PCR-based lung cancer reflex diagnostic test has been validated in a key clinical trial, clearing the way for the test to receive the CE Mark for in vitro diagnostics and for the company to launch the test in Europe in coming weeks.

Synlab has started offering Epi proColon, Epigenomics' PCR-based blood test for early detection of colorectal cancer, through 55 German sites in its network. In addition, Epigenomics recently raised €33.1 million ($44.2 million) through a combined private and public share offering.

Wafergen said that the agreement would support the commercialization strategy for its SmartChip Real-Time PCR system, due to launch later this year.

European customers using or planning to use the 7500 Fast Dx instrument to develop in vitro diagnostic content now have a "much easier" path when submitting a complete IVD platform for regulatory approval by European authorities, a Life Tech official said.

Promega's Maxwell 16 IVD System, Norgen Biotek's diagnostic kits

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The World Health Organization has announced the members of its gene-editing committee, according to NPR.

DARPA is working on developing algorithms that gauge the credibility of research findings, Wired reports.

The American Society of Breast Surgeons recommends all women diagnosed with breast cancer be offered genetic testing, the Washington Post says.

In Science this week: comparison of modern, historical rabbit exomes uncovers parallel evolution after myxoma virus exposure; and more.