Companion Diagnostics

News on companion diagnostics and drug/test co-development.

Japanese Regulators Approve Invivoscribe Assay as CDx for Daiichi Sankyo AML Drug

The LeukoStrat CDx FLT3 Mutation Assay can now be used in Japan as the CDx for quizartinib for the treatment of FLT3-ITD positive relapsed or refractory AML.

Resolution Bioscience, Janssen Partner to Develop CDx for Niraparib in Prostate Cancer

Resolution is developing its liquid biopsy assay as a companion diagnostic for niraparib in metastatic castration-resistant prostate cancer.

AstraZeneca, Merck's Lynparza, Myriad Genetics' BRCA Test Approved in Japan

The drug is for first-line maintenance therapy after BRCA-mutated advanced ovarian cancer patients respond to platinum chemo and the test will identify those with BRCA mutations.

Almac NGS-Based CDx Gets CE Mark

Almac said that the assay will be used in a clinical study of repotrectinib (TPX-0005), an investigational, next-generation tyrosine kinase inhibitor.

FDA Approves Qiagen's PIK3CA Test as Companion Test for Novartis Breast Cancer Drug

The test will be used to identify which advanced or metastatic breast cancer patients with PIK3CA mutations are likely to respond to Novartis' alpelisib.

May 07, 2019

Adial Pharmaceuticals, Eurofins Scientific Partner on CDx for Alcohol Use Disorder Drug

May 06, 2019

FDA Grants IDE Approval for Almac Diagnostic Services' CDx for Use in Cancer Drug Study

Apr 12, 2019

FDA Approves Qiagen Companion Dx for Bladder Cancer Drug Balversa

Apr 09, 2019

Myriad Submits MyChoice HRD as Companion Diagnostic for GSK's Zejula

Apr 04, 2019

Myriad Genetics, AstraZeneca, Merck Expand BRCA CDx Collaboration

Apr 03, 2019

LabCorp Joins Qiagen Program to Accelerate Companion Diagnostic Commercialization

Apr 03, 2019

Cellgen, Genomics Testing Cooperative Form Cancer Companion Diagnostic Alliance

Apr 01, 2019

FLT3 Inhibitor Treatment Improves Survival in Relapsed, Refractory AML Patients With Mutations

Mar 28, 2019

Mission Bio, LabCorp Collaborate on Clinical Trials, Companion Dx Development

Mar 21, 2019

Dalcor Holds Firm on Plans for Dalcetrapib Despite Negative Merck Results

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Mar 19, 2019

Glaucoma Diagnostic Targeted by Mannin Research, McMaster University Collaboration

Mar 12, 2019

Biocartis Inks Cancer CDx Deal With Bristol-Myers Squibb

Mar 01, 2019

AmoyDx Wins Chinese Regulatory Approval for BRCA Mutation Test

Feb 26, 2019

Thermo Fisher Scientific Oncomine Dx Target Test Gets Expanded Regulatory Approval in Japan

Feb 21, 2019

Caris Prepares FDA Submission of RNA Sequencing Test; Will Include Companion Dx Claims for Fusions

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Feb 05, 2019

Japanese Regulators Approve Promega CDx for Merck's Keytruda

Jan 16, 2019

Qiagen EGFR Assay Approved in Japan as CDx to Pfizer NSCLC Drug

Jan 14, 2019

MDxHealth Preliminary 2018 Revenues Drop Nearly 1 Percent

Jan 08, 2019

Circulogene Broadens Push Into Companion Diagnostics with NTRK Fusion Assay

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The Scan

New Privacy Coalition

Three genetic testing companies form a coalition to influence how Congress considers genetic privacy, The Hill reports.

Less Sweat, More Diverse Microbiome

University of California, San Diego researchers investigate how skin care products influence the skin microbiome, Scientific American reports.

Oh, This Code

The Wall Street Journal examines billing codes used by uBiome.

PNAS Studies Look at Lung Cancer LncRNA, Hi-C Clustering, and More

In PNAS this week: links between lung adenocarcinoma and lncRNA, algorithm to impute and cluster Hi-C interaction profiles from single cells, and more.

Featured White Papers

Evaluation of the Oncomine BRCA Research Assay for Variant Detection by Next-Generation Sequencing

Jul

30

Featured Webinar

Single-Cell Sequencing Reveals Clonal Heterogeneity in Acute Lymphoblastic Leukemia

This webinar will outline a project that performs large-scale and integrative single-cell genome and transcriptome profiling of pediatric acute lymphoblastic leukemia (ALL) cases at diagnosis, during drug treatment, and in case of relapse.

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