The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
On Monday, November 15, 2021, the Food and Drug Administration (FDA) announced that the U.S. Department of Health and Human Services (HHS) repealed a policy established by the Trump administration that directed the FDA not to...more
Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more
Scientists at the University of California-San Francisco (UCSF) have developed a single test, Metagenomic Next-Generation Sequencing (mNGS), that can rapidly identify infectious microbes in body fluids, increasing the speed...more
Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more