Affymetrix Inc. has announced that the Affymetrix Clinical Services Laboratory (ACSL) successfully passed the State of California survey for CLIA (Clinical Laboratory Improvement Amendments) certification on April 9, 2007.
The State of California inspector gave ACSL permission to begin offering microarray-based molecular diagnostic patient and clinical trial testing services. These services are designed to improve healthcare and help customers develop personalized tests and therapies faster than ever before.
The Affymetrix-owned and -operated laboratory enables clinical and research laboratories, as well as diagnostic and pharmaceutical companies, to incorporate complex molecular tests into clinical practice.
The CLIA certification ensures that all of its processes are standardized to consistently meet federal and Clinical Laboratory Standards Institute (CLSI) guidelines for accuracy, precision, sensitivity, calibration and control. In addition, all of the ACSL assays have been validated for clinical applications to help ensure reproducible results.
ACSL uses the industry-standard GeneChip® microarray platform, which is the only platform to have earned 510(k) clearance from the United States Food and Drug Administration and to have secured the CE mark from the European Union. A team of licensed and board-certified personnel processes all of the samples and manages data to help ensure the highest quality results.
"The Affymetrix GeneChip® System 3000Dx is the first microarray instrumentation system cleared for molecular diagnostic laboratories and it is becoming the platform of choice for clinical trials and clinical care," said Noel Doheny, senior vice president, molecular diagnostics business unit at Affymetrix. "ACSL will further facilitate this broad adoption of array-based diagnostic tests and help make personalized medicine a reality."