FDA

Flu Antigen Tests Reclassified as Class II Devices

Effective this month, the U.S. Food and Drug Administration (FDA) has reclassified antigen-based, rapid influenza virus antigen detection test systems (RIDTs) used directly on clinical specimens from … [Read more...]

LDTs

FDA Discussion Paper Synthesizes Stakeholder Feedback on LDT Regulation

Last December, the U.S. Food and Drug Administration announced that it would not finalize the guidance on agency oversight of laboratory developed tests (LDTs) that it proposed back in 2014— at least … [Read more...]

LDTs

FDA Synthesizes Feedback on LDTs in New Discussion Paper

Following up its decision not to issue final guidance in 2016 regarding oversight of laboratory developed tests (LDTs), the U.S. Food and Drug Administration released a discussion paper Friday, Jan. … [Read more...]

LDTs

No Final LDT Framework in 2016: FDA Seeks Further Input from Stakeholders, New Administration

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...]

LDTs

FDA Won’t Release Final LDT Guidance in 2016

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...]

PUBLIC HEALTH

CDC and the Diagnostics Industry Continue to Battle Zika

While summer has ended, the battle against the mosquito-borne virus Zika continues. On Oct. 21, the Centers for Disease Control and Prevention (CDC) announced approximately $70 million will be made … [Read more...]

PATIENT SAFETY

FDA Recommendation Against Ovarian Cancer Screening

The U.S. Food and Drug Administration (FDA) recommends against using currently available tests to screen for ovarian cancer, according to a safety communication the agency issued at the beginning of … [Read more...]

LEGISLATION

FDA Considers Liquid Biopsies

In addition to laboratory developed tests and next generation sequencing, could the FDA be looking to impose standards or guidance governing use of liquid biopsies? So-called "liquid biopsies" are … [Read more...]

FDA

Public Comment Sought on Blood Donor Deferral Policies to Reduce HIV Transmission

While the annual rate of new diagnosed cases has declined in the last 10 years, HIV still remains a significant concern. The Centers for Disease Control and Prevention (CDC) reports approximately … [Read more...]

TECHNOLOGY

As Congress Asks Theranos for Documentation, Its CEO Zigs to A Whole New Platform

Its business plan and technology under fire, Theranos appears to be playing metaphorical three-card monte with federal lawmakers and the laboratory community curious as to whether it will become a … [Read more...]


(-0000g2)