Healthcare Dive

5 steps to navigate the FDA’s new lab developed test rule

Laboratories are just beginning to assess the magnitude of operational changes needed to comply with a new federal rule expanding regulatory oversight of lab developed tests (LDTs). In a major shift, ...
Medicine Buffalo

FDA-approved screen for Alzheimer’s boost for nursing wet lab

The Food and Drug Administration’s recent approval of a new blood test to aid in the diagnosis of Alzheimer’s disease is a boost for the School of Nursing’s wet lab. The lab, led by nursing researcher ...
KVOA 4

Roche receives FDA approval for first diagnostic tests to identify HER2-positive metastatic breast cancer patients eligible for ENHERTU

This approval reflects the vital role of advanced diagnostics in guiding precise treatment decisions to address the diverse needs of mBC patients. "Metastatic breast cancer remains a significant ...
Business Wire

Thermo Fisher Scientific’s Oncomine Dx Target Test Receives FDA Approval as a Companion Diagnostic to Identify Patients Eligible for Newest Targeted Therapy for Non-Small ...

CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent™ Oncomine™ ...
Nasdaq

Immunovia: CPT PLA Code for the IMMray™ PanCan-d test approved

LUND, Sweden, July 5, 2022 /PRNewswire/ -- Immunovia AB (NASDAQ Stockholm: IMMNOV) announced, that Immunovia, Inc., its American subsidiary, has recently received approval for a Current Procedural ...
Medicine Buffalo

Nursing wet lab equipped to carry out FDA-approved screen for Alzheimer’s

BUFFALO, N.Y. – The Food and Drug Administration’s recent approval of a new blood test to aid in the diagnosis of Alzheimer’s disease is a boost for the University at Buffalo School of Nursing’s wet ...