Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Interfering With Invasive Mussels

The Chicago Tribune reports that researchers are studying whether RNA interference- or CRISPR-based approaches can combat invasive freshwater mussels.

Participation Analysis

A new study finds that women tend to participate less at scientific meetings but that some changes can lead to increased involvement, the Guardian reports.

Right Whales' Decline

A research study plans to use genetic analysis to gain insight into population decline among North American right whales, according to CBC.

Science Papers Tie Rare Mutations to Short Stature, Immunodeficiency; Present Single-Cell Transcriptomics Map

In Science this week: pair of mutations in one gene uncovered in brothers with short stature and immunodeficiency, and more.