Iris Biotech to Submit Microfluidics-Based Breast Cancer Chip to FDA by End of Year | GenomeWeb
Iris Biotechnologies, a Santa Clara, Calif.-based diagnostics company, plans to submit its first assay to the US Food and Drug Administration for 510(k) clearance as an in vitro diagnostic by the second half of this year, according to a company official.
 
CEO Simon Chin told BioArray News last week that the test, called BreastCancerChip, designed to determine treatments for women with breast cancer, will become available as both a catalog product and as a service sometime this year.
 

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