FDA approves new lung cancer diagnostic tool, intraveneous opioid

Aug 10, 2020 - 03:00 PM
FDA product update

The Food and Drug Administration Friday approved the first liquid biopsy companion diagnostic that uses next-generation sequencing technology to identify patients with specific gene mutations in a deadly form of metastatic non-small cell lung cancer.

“In addition to benefitting from less invasive testing, patients are provided with a simultaneous mapping of multiple biomarkers of genomic alterations, rather than one biomarker at a time, which can translate to decreased wait times for starting treatment and provide insight into possible resistance mechanisms,” said Tim Stenzel, M.D., director of FDA’s Office of In Vitro Diagnostics and Radiological Health.

In other news, the agency Friday approved a new intraveneous opioid for managing acute pain in adults in hospital and other controlled clinical settings, such as inpatient and outpatient procedures. The drug, Olinvyk (oliceridine), has a maximum recommended daily dose limit of 27 milligrams.

Related News Articles

Headline
AHA launches online collaborative focused on quality improvement
The AHA Living Learning Network is launching the Quality Exchange, a virtual collaborative for health care quality and patient safety professionals at…
Headline
Court strikes down FDA rule on regulating lab-developed tests
The U.S. District Court for the Eastern District of Texas March 31 ruled that the Food and Drug Administration does not have the authority to regulate…
Headline
AHA webpage highlights how hospitals and health systems integrate patient safety
As part of the AHA's Patient Safety Initiative, a dedicated webpage features case studies showing how hospitals and health systems across the nation are…
Blog
Can Collaborative Efforts to Improve Device Design Improve Safety?
Public
During World War II, the U.S. Army Air Corps depended on its B-17 bombers to inflict incredible damage against the Axis powers in Europe. These “Flying…
Headline
AHA podcast: A Great Catch — Strategies for Building a Culture of Safety Reporting
Mindy Estes, M.D., former CEO of Saint Luke’s Health System and former AHA board chair, and Nancy Howell Agee, CEO emeritus of Carilion Clinic and former AHA…
Headline
Survey: Positivity wanes to new low on Americans’ mental and physical health
Americans' assessments of their mental and physical health are the least positive they have been in the history of Gallup’s 24-year poll on the subject, with…