FDA

FDA Watch: New FDA Approvals & Applications in Diagnostics

A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine's FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test. The FDA … [Read more...]

GENETIC TESTING

Sequencing Not Ready for First-Line, Newborn Screening

Scientists have been exploring the "hows" and "what ifs" of applying sequencing to newborn screening. However, two new National Institutes of Health-sponsored studies presented at … [Read more...]

FDA

CDRH Emphasizes Biomarkers and Precision Diagnostics in 2017 Priorities

Precision medicine and biomarkers can help the U.S. Food and Drug Administration (FDA) ensure safety of medical devices. That's according to the FDA Center for Devices and Regulatory Health's (CDRH) … [Read more...]

DEALS

Quest Diagnostics Leads Personalized Medicine Developments

Public support for personalized and precision medicine (PM) is running ahead of the health care industry's plans to develop and implement PMbased clinical strategies. At least that is the conventional … [Read more...]

PRECISION MEDICINE

21st Century Cures Act: Moves Closer to Becoming Law

Update: December 7, 2016, the U.S. Senate voted 94 to 5 to pass the 21st Century Cures Act which now moves to President Obama who has indicated that he will sign it "as soon as it reaches my desk." … [Read more...]

EMERGING TESTS

Blood Glucose Monitoring Developments Focus on Mobility, Convenience

According to the Centers for Disease Control and Prevention (CDC) more than 29 million U.S. residents have diabetes. The agency also reports that medical costs for diabetics are twice as high as … [Read more...]

LDTs

FDA Oversight of LDTs Delayed for Consultation with New Administration, Stakeholders

The U.S. Food and Drug Administration (FDA) has provided laboratories with some much needed good news—the agency will not finalize its laboratory-developed test (LDT) guidance document before the end … [Read more...]

GENETIC TESTING

DTC Test Results Don’t Lead to Dramatic Changes in Health Care Use

The U.S. Food and Drug Administration (FDA) has frequently expressed concern about direct-to-consumer (DTC) marketing of genetic testing. For example, the FDA required pre-market approval for … [Read more...]

FDA

FDA’s 2017 Priorities Emphasize Biomarkers and Precision Diagnostics

Precision medicine and biomarkers can help the U.S. Food and Drug Administration (FDA) ensure safety of medical devices. That's according to the FDA Center for Devices and Regulatory Health's (CDRH) … [Read more...]

GENETIC TESTING

Genetic Testing: More Options Require More Education

Increasing diagnostic options for providers and patients was a common theme throughout panel discussions and presentations at the 34th annual Lab Institute in Washington, D.C. Oct. 26-28, 2016. … [Read more...]


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