FDA

The Israeli firm recently announced the results of a multicenter study of its Bladder EpiCheck test in addition to netting €2.5 million in EU funding to develop a lung cancer assay.

The company beat the consensus Wall Street estimate on the top line but missed it on the bottom line. It placed 39 net new ePlex analyzer during the quarter.

The Cobas HPV Test is now approved for use as a primary screening test with BD's SurePath and Hologic's ThinPrep PreservCyt Solution.

Duchenne Trial Halted

Stat News reports federal regulators have halted Sarepta Therapeutics' Duchenne muscular dystrophy gene therapy trial.

The firm said that its average revenue per clinical genetic test decreased by almost 4 percent to $318, primarily due to changes in Medicare reimbursement and regulation.

The system is for high-throughput testing in central labs and the firm plans additional assays for infectious and sexually transmitted diseases.

This drug is the first FDA-approved IDH1 inhibitor and will be used to treat adult patients with relapsed or refractory acute myeloid leukemia.

The FDA said that pooled testing of donations using a screening test that it has licensed is a sufficient method for complying with its testing regulations.

It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.

The new assay simultaneously detects four viral targets in donated blood plasma in a single sample and can add value to the biologics development space.

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New results from the NASA Twins Study indicate that the immune system may rev up when in space, the Washington Post reports.

Kelvin Droegemeier, the new science advisor, spoke at the American Association for the Advancement of Science meeting, Geekwire reports.

In PNAS this week: whole-genome assembly for the white shark, paper-based microfluidic method for detecting the malaria parasite, and more.

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