Genotyping Test for Cystic Fibrosis

The multiplexed test has been cleared by the U.S. Food and Drug Administration (FDA) as an in vitro device for diagnostic use.

The test will be used to determine CF carrier status in adults, as an aid in newborn screening, and in confirmatory diagnostic testing in newborns and children. Performance testing has established that the Tag-It CF kit operates with 100% accuracy and greater than 99.9% reproducibility. The test screens for 23 CFTR gene mutations and four variants. In addition, the kit screens for 16 additional mutations. The kit is not indicated for use as a fetal diagnostic, for pre-implantation testing, or for stand-alone diagnostic purposes.

The test was developed by Tm Bioscience (Toronto, Canada). All of the company's genetic tests are based on the Tag-It universal array platform, which utilizes a proprietary universal tag system that allows for easy optimization, product development, and expansion. Assays from Tm Bioscience operate on the Luminex xMAP system, a bead-based instrument. The company's pipeline includes tests for genetic disorders, drug metabolism, and infectious diseases.

"Clearance by the FDA of a genetic assay for cystic fibrosis provides a highly standardized product for laboratories that offers tremendous benefits to the genetic testing industry, physicians, and to patients,” observed Dr. Michael Watson, executive director, American College of Medical Genetics.




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