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FDA Tells Celera KIF6 Test Unapprovable Without Changes

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has told Celera that its application for pre-market approval of its KIF6 Genotyping Assay is not approvable "without major amendment," Celera disclosed after the close of the market on Wednesday.

Celera received the letter on April 7 saying the data and peer-reviewed publications that the Alameda, Calif.-based firm submitted to support its PMA "are insufficient to demonstrate the safety and effectiveness of the device for its proposed intended use."

Celera added that FDA told it that it may have to collect additional data on clinical utility to demonstrate the safety and effectiveness of its KIF6 Genotyping Assay. Such a process could include conducting a prospective, randomized clinical control trial.

Celera has requested a meeting with the agency to discuss the deficiencies and how to proceed toward regulatory approval.

The test is CE Marked and is marketed in Europe and other countries that recognized the CE Mark. Celera's Berkeley HeartLab business also has performed the test at its Alameda, Calif.-based CLIA lab since 2008.

Celera, which is in the process of being acquired by Quest Diagnostics, filed with FDA in January to run the assay on Abbott's m2000 molecular diagnostics platform. The test is for detecting a variant in the KIF6 gene that could be used in conjunction with clinical evaluation and patient assessment to evaluate a patient's risk for coronary heart disease.