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FDA approves next|generation cancer biomarker test and ...


FDA approves Illumina cancer biomarker test with two companion ...

Illumina announced FDA approval of its cancer biomarker test with two companion diagnostics to rapidly match. Cision View original content to ...

FDA approves next-generation cancer biomarker test and ... - ADLM

FDA approves next-generation cancer biomarker test and companion diagnostics · Companion Diagnostic for Synovial Sarcoma Gets FDA 510(k) ...

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

... test for multiple cancers and biomarkers, Food and Drug Administration ... FDA Approves Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test ...

FDA Approves Cancer Biomarker Test, Companion Diagnostic ...

The US Food and Drug Administration (FDA) has approved the in vitro diagnostic TruSight Oncology (TSO) Comprehensive test and its first two companion ...

FDA-Approved and Emerging Next Generation Predictive ...

Three currently FDA-approved predictive biomarkers (progra1mmed cell death ligand-1 (PD-L1); microsatellite instability (MSI); tumor mutational burden (TMB)) ...

FDA approves liquid biopsy NGS companion diagnostic test for ...

On November 6, FDA approved the FoundationOne Liquid CDx test as a companion diagnostic device to identify mutations in BRCA1, BRCA2 and ATM ...

FDA approves Illumina cancer biomarker test with two companion ...

Illumina announced FDA approval of its cancer biomarker test with two companion diagnostics to rapidly match patients to targeted therapies.

Illumina's IVD Biomarker Test Becomes the First FDA-approved Pan ...

Illumina's TSO Comprehensive is the first FDA-approved comprehensive genomic profiling IVD kit with pan-cancer companion diagnostic claims.

FDA Approves Illumina Cancer Biomarker Test

SAN DIEGO – DNA-sequencing giant Illumina (Nasdaq: ILMN) won approval from the Food and Drug Administration (FDA) for its cancer biomarker ...

FDA Approves Biomarker Test for Use in NSCLC, Other Solid Tumors

The FDA has approved Illumina's TruSight Oncology Comprehensive test to identify cancer patients who may benefit from certain targeted ...

TruSight Oncology Test Receives FDA Approval for NTRK and RET ...

The test is approved to identify patients with solid tumors harboring NTRK gene fusions and non–small cell lung cancer (NSCLC) harboring RET ...

FDA FACT SHEET

NEXT GENERATION SEQUENCING TESTS. The Food and Drug Administration (FDA) has ... Three-Tiered Approach for Reporting Biomarkers in Tumor Profiling NGS Tests.

FDA approves Illumina's tumor biomarker test as a pan-cancer ...

Illumina has secured an FDA approval to bring its pan-cancer tissue profiling test to U.S. shores. A version of the company's TruSight ...

FDA Authorizes Blood Test for Hereditary Cancer Risk - NCI

FDA has authorized the Invitae Common Hereditary Cancers Panel, a blood test that detects inherited genetic changes that increase the risk ...

FDA Approves Cancer Biomarker Test with Two Companion ...

The FDA approved Illumina's oncology comprehensive test as an IVD tool, along with its first two CDx indications for cancer patients.

FDA Approves First Liquid Biopsy Next-Generation Sequencing ...

The Guardant360CDx is approved both to provide information on multiple solid tumor biomarkers and to help identify EGFR mutations in patients ...

Next-Generation Companion Diagnostics

The basic premise of next-generation companion diagnostics is the use of an FDA-approved drug/biomarker combination based on a cancer's genomic and proteomic ...

FDA Approves New Targeted Treatment For Advanced Hormone ...

Despite the prevalence of PIK3CA mutations, many people are not tested until later in their treatment journey. Early, comprehensive biomarker ...

Guardant360® CDx: Fastest FDA-Approved Liquid CGP Panel

... FDA-approved liquid CGP test across all advanced solid tumors ... FDA approves first liquid biopsy next-generation sequencing companion diagnostic test.

List of Cleared or Approved Companion Diagnostic Devices - FDA

A companion diagnostic device can be in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective ...