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FDA Asks Clinical Data to Discuss Regulatory Status of Its Tests

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has asked Clinical Data to “discuss the nature and appropriate regulatory status” of the company’s diagnostic tests, Clinical Data said today.
Specifically, the firm and the FDA will discuss whether “any regulatory requirements apply, [and] the least burdensome ways that the company may fulfill them,” Clinical Data said.
The company said it plans to meet with the FDA “in the near future.”
“The company looks forward to meeting with the FDA and reviewing the regulatory status for all tests conducted on behalf of end-users including FAMILION, its CLIA-certified test for cardiac channelopathies that requires a prescription by healthcare providers,” Clinical Data said in a statement.
“Clinical Data notes that while it conducts DNA assays for one nutrigenomic test on behalf of a third party customer, the test is not marketed by Clinical Data and revenue from this test is immaterial” to its business, the company said.
“The company believes it is in compliance with all applicable state and federal regulations and will continue to work with the appropriate regulatory agencies to remain so,” Clinical Data said.

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