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Gensignia Gets Initial CLIA Licensure From California

NEW YORK (GenomeWeb) – Cancer molecular diagnostics shop Gensignia today said that California has granted it an initial CLIA clinical laboratory license. 

With the license granted under the "deemed status" provision of the Centers for Medicare and Medicaid Services, the San Diego-based company plans to establish a clinical laboratory to offer its Gensignia miRNA Signature Classifier for Lung Cancer Test, as well as other tests in the future, Gensignia CEO Lee McCracken said. 

The plasma-based test was developed with the aim of decreasing the high rate of false positives from low-dose computed tomography (LDCT), the firm said on its website. It said that about 25 percent of patients who undergo LDCT are thought to have lung cancer, but about 96 percent of those positive scans turn out to be false positives. Gensignia's test can be used to confirm LDCT scans, reducing the need for additional diagnostic workups, it said.