PRECISION MEDICINE

Discordant Commercial, Next-Gen Tumor Profiling Results May be Clinically Relevant

Next-generation sequencing is increasingly becoming commonplace to match cancer-associated alterations with targeted treatments. But, a new study raises concerns that marked differences in results … [Read more...]

INVESTMENT

Dx Investments Hold Steady in 2016, Number of Exits Declines

Investments in the diagnostics and tools (Dx/Tools) sector remained steady in 2016, according to Silicon Valley Bank's annual report, Trends in Healthcare Investments and Exits 2017. The report … [Read more...]

INVESTMENT

2016 Investments Steady, Exits Decline

Investments in the diagnostics and tools (Dx/Tools) sector remained steady in 2016, according to Silicon Valley Bank's annual report, Trends in Healthcare Investments and Exits 2017. The report … [Read more...]

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...]


(-0000g2)