NEW YORK (GenomeWeb News) - Affymetrix said today its Clinical Services Lab has been certified to begin offering microarray-based molecular diagnostic testing under Clinical Laboratory Improvement Amendments.
The ACSL, a 10,000 square-foot lab in Sacramento, Calif., will be used for clinical trial and patient testing, the company said.
The facility's offerings include gene expression monitoring, genotyping, chromosomal copy number analysis, and other molecular diagnostic tests.
Affy said that the lab has already signed two agreements with customers.
CLIA certification ensures that the lab's processes meet standards for accuracy, precision, sensitivity, calibration, and control under federal and Clinical Laboratory Standards Institute regulations.
All of the lab's assays have also been validated for clinical applications, the company said.
Affy said the lab received the clearance on April 9.