NEWTON, Mass.--(BUSINESS WIRE)--Clinical Data, Inc. (NASDAQ: CLDA) announced today that it intends to oppose a Citizen Petition filed with the U.S. Food and Drug Administration (FDA) by Genentech, Inc. (NASDAQ: DNA), which requested that the agency regulate more stringently all laboratory-developed tests (LDTs) that are used to guide therapeutic decisions – tests that are the essence of personalized therapies. Clinical Data’s genetic biomarker-based tests, including its PGxPredict® tests to assist in predicting a patient’s response to specific drugs, have been developed according to current regulatory requirements and are performed in strict compliance with the Clinical Laboratory Improvement Amendments (CLIA). The development and use of these tests are based on sound scientific evidence, and provide demonstrable clinical value in aiding physicians and patients in making more informed treatment decisions.
