NEW YORK (GenomeWeb News) – New Zealand cancer diagnostics company Pacific Edge said today its US Laboratory has achieved registration under the CLIA regulatory process, setting the stage for it to offer its bladder cancer test in the US.

CLIA registration means that Pacific Edge's laboratory in Hershey, Penn., will be able to operate and process urine samples from patients in the US for its laboratory-developed test called Cxbladder. The non-invasive, urine-based test uses molecular signatures to identify the presence of bladder cancer tumors.

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The US Food and Drug Administration has new guidelines that enable some gene and cell therapies to undergo expedited review, according to the New York Times.

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