RAPS

Companion diagnostics: FDA finalizes guidance to broaden labeling for precision oncology

The US Food and Drug Administration (FDA) on Monday finalized guidance aimed at encouraging broader labeling for companion diagnostics used to guide precision oncology treatments and to facilitate ...
TMCnet

Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer's VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced ...

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Guardant360® CDx liquid biopsy test as a ...

The Bull Case For Agilent Technologies (A) Could Change Following Exclusive FDA Approval Of Its KEYTRUDA Test

Agilent Technologies has recently received U.S. FDA approval for its PD-L1 IHC 22C3 pharmDx assay as the only companion ...
Nasdaq

Labcorp: FDA Approves NAbCyte Companion Diagnostic - Quick Facts

(RTTNews) - Labcorp (LH) announced the FDA has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic to determine patient eligibility for treatment with BEQVEZ, Pfizer's recently ...
Monthly Prescribing Reference

FDA Approves Companion Diagnostic for Hemophilia B Gene Therapy Beqvez

If a patient tests positive for antibodies to AAVRh74var, Beqvez should not be administered. Beqvez is indicated for the treatment of adults with moderate to severe hemophilia B who currently use ...
Business Wire

QIAGEN receives FDA approval for companion diagnostic to Mirati Therapeutics’ KRAZATI in non-small cell lung cancer

GERMANTOWN, Md. & HILDEN, Germany--(BUSINESS WIRE)--QIAGEN (NYSE:QGEN; Frankfurt Prime Standard: QIA) has announced the U.S. Food and Drug Administration (FDA) approval of its therascreen ® KRAS RGQ ...
The Scientist

How AI is De-Risking Drug Development and Companion Diagnostics

Digital pathology and artificial intelligence are transforming the drug development landscape, accelerating the path to ...
Nasdaq

Illumina's Cancer Biomarker Test With Two Companion Diagnostics Gets FDA Approval

(RTTNews) - Illumina, Inc. (ILMN), Tuesday announced Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight Oncology (TSO) Comprehensive test and its first two companion ...
Business Wire

U.S. Food and Drug Administration (FDA) Approves FoundationOne®Liquid CDx as a Companion Diagnostic for AKEEGA® (niraparib and abiraterone acetate) for Patients with BRCA ...

BOSTON--(BUSINESS WIRE)--Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion ...
RAPS

FDA Drafts Guidance on Oncology Companion Diagnostics

The US Food and Drug Administration (FDA) said it was encouraged to help guide developers of companion diagnostics toward newly drafted policies in support of broader labeling. “We’re concerned that ...
FierceBiotech

Agilent companion diagnostic lands FDA nod alongside Keytruda's latest cancer approval

As Merck received its latest FDA nod for Keytruda in ovarian cancer, Agilent gained the green light for its accompanying test to identify patients who can best benefit from the drug. The test, PD-L1 ...