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Companion Diagnostics

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

Becton Dickinson, Navigate BioPharma Collaborate on Flow Cytometry Companion Diagnostics Development

The partners will offer their combined expertise to biopharma companies developing diagnostics and clinical decision-making tools.

Guardant Health Receives Guardant360 CDx Regulatory Approval in Japan for HER2 Lung Cancer Treatment

Patients who test positive for a HER2 mutation and have seen their disease progress after chemotherapy can now be treated with Daiichi Sankyo's Enhertu.

Agilent Technologies Shuttering Resolution Bioscience Business
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For Q3, the firm said its diagnostics revenues rose 3 percent, but Resolution's kitted NGS-based companion diagnostics business hadn't developed as expected.

AmoyDx, AstraZeneca Partner on HER2 Lung Cancer CDx Development in China

Amoy will develop a companion diagnostic for Enhertu (trastuzumab deruxtecan) under its latest agreement to develop companion diagnostics for AstraZeneca's therapies.

FDA Approves Foundation Medicine CDx for Use With Janssen Drug in Prostate Cancer Patients

The test will be used as a companion diagnostic for patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.

Aug 8, 2023

Qiagen CDx for GI Cancer Treatment Ayvakit Gets FDA Approval

Jul 31, 2023

Amoy Diagnostics, AstraZeneca Partner to Advance PARP Inhibitor CDx For Maintenance Indication

Jul 21, 2023

Invivoscribe Gets FDA Approval for LeukoStrat CDx for Daiichi Sankyo Leukemia Drug

Jul 6, 2023

Tempus, TScan Therapeutics Partner on CDx for T-Cell Receptor Therapy in Solid Tumors

Jun 29, 2023

At FDA and in Utah, Transparency Projects Probing Lab Test Quality in Cancer Care
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Jun 20, 2023

FDA Launches Pilot Program to Determine Performance Criteria for Lab-Developed CDx Tests

Jun 9, 2023

Foundation Medicine Blood Test Gets FDA Approval as CDx for Pfizer's Braftovi in Colorectal Cancer

Jun 5, 2023

Foundation Medicine, Merck KGaA to Collaborate on Companion Diagnostics

May 17, 2023

Guardant Health Secures New Commercial Payor Coverage for Liquid Biopsy Cancer Profiling Test

May 11, 2023

Formerly PerkinElmer, Revvity Discusses Plans, Goals as Dx, Life Science Firm
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May 11, 2023

Invivoscribe Leukemia CDx Assay Nabs IVDR Approval

May 4, 2023

FoundationOne Liquid Biopsy Assay Gets FDA OK as Companion Diagnostic for Takeda's Exkivity

May 1, 2023

Tempus Gains FDA Premarket Approval for NGS Solid Tumor Profiling Test

Apr 18, 2023

Myriad Genetics, Intermountain Precision Genomics Obtain NY Certification for Solid Tumor Testing

Apr 14, 2023

AiGene Aims to Remodel Clinical Trials With ctDNA Tech for On-Treatment Response Monitoring
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Apr 11, 2023

Foundation Medicine, Bristol Myers Squibb Expand CDx Partnership to Investigational Cancer Drug

Apr 3, 2023

Theralink Acquires Immunotherapy Biomarker Patent From Vanderbilt University

Mar 27, 2023

Amoy Diagnostics PLC Panel Gets Approval in Japan as CDx for Retevmo in Non-Small Cell Lung Cancer

Mar 9, 2023

Servier, Qiagen to Develop PCR-Based Companion Diagnostic to Identify IDH1-Mutant Leukemia

Mar 2, 2023

Illumina, Myriad Genetics Expand Partnership to Bring TSO 500 HRD Assay to US

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The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.